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TerminatedNCT02144233MAPUpdated Apr 22, 2020Results posted

Restoring Masticatory Function to Treat Chronic Pain

An interventional study of Occlusal adjustment and Placebo occlusal adjustment in Temporomandibular Joint Dysfunction Syndrome and Chronic Pain, sponsored by Urbano Santana Penin, MD, DDS, PhD. Terminated at 2 sites in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-04-22.

Sponsored by Urbano Santana Penin, MD, DDS, PhD · Not applicable, Interventional, and Treatment

Why this study was terminated
Interim analysis showed benefice of one therapy over the other one.
Phase
Not applicable
Study type
Interventional
Enrollment
77
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The primary endpoint will be the average change in pain score from baseline to the three- and six-month assessments. Efficacy will be demonstrated by superior pain relief with the active treatment compared with the placebo.

Read the detailed description
  • The cause of temporomandibular joint (TMJ) disorders (TMD) remains unknown and therapy is usually empirical. Systematic reviews have concluded that currently there is no evidence that occlusal adjustment has any therapeutic or preventive effect on temporomandibular disorders. However, these reviews also indicate that evidence to the contrary has not been provided and that more research is needed to elucidate whether there is any benefit of occlusal adjustment treatment for TMD. The risk factors for chronic unilateral TMD include a steeper condylar path, flatter lateral anterior guidance, and habitual chewing on the affected side. Consequently, a new occlusal therapy is proposed to restore the physiological jaw closure and masticatory function.
  • The primary end point of the trial is to assess the efficacy of the new occlusal therapy on the affected side TMD pain, and the maximum mouth opening. Efficacy is demonstrated by showing significantly superior pain relief and increasing maximum mouth opening (when it was limited) with the active treatment compared with placebo.

Phase III, single center, randomized, parallel-group, single-blind with blinded assessment, placebo-controlled clinical trial.

  • A linear mixed model will be performed for comparisons of most variables and a logistic regression model will be used to measure the probability/risk of change on the chewing side between baseline and six months; in addition, McNemar's test may be used.
  • Interim analysis plan and stopping rules. The study will employ an interim analysis plan with a single interim analysis after 70% of participants have completed the six-month follow-up visit. Using the Lan-DeMets version of the O'Brien-Fleming stopping rule, the critical value for statistical significance at the interim analysis (under intention-to-treat approach) will be +2.438, corresponding to a nominal two-sided P value of 0.0146.

Participants remaining with significant pain (and/or limited mouth opening) after the study will be invited to follow the conventional treatment, or to "complete" occlusal adjustment (rescue therapy): the full adjustment (if they were placebos), or a refining (if they received real therapy); the kind of received therapy will not be disclosed to participants. It based on the researchers' conviction, participants are encouraged to receive electively "complete" occlusal adjustment. All participants will be reevaluated between 3 to 6 months after study (12-Mo follow-up). Although no pain was reported at the 6-Mo follow-up, if pain returns, same approach will be carried out. Two sessions occlusal adjustment will be carried out and, if the pain remains, the patient will be treated following the Hospital approaches. The evolution of patients during post-MAP period, until writing of the manuscript, will be reported in the same manuscript, even if MAP result early stopped.

Additional patient's monitoring until next five years after treatment is expected.

02

Conditions studied

  • Temporomandibular Joint Dysfunction Syndrome
  • Chronic Pain

Keywords

  • Pain
  • Temporomandibular joint disorders
  • Occlusal adjustment
  • Therapy
  • Randomized clinical trial
  • Mastication
  • Habitual chewing side
  • Handedness preference
  • Jaw asymmetry
03

In context

Joint Diseases

712 studies on the registry are indexed under Joint Diseases; 127 are open to participants now.

This study's enrollment of 77 is above the median of 60 across 470 interventional studies indexed under Joint Diseases.

Browse Joint Diseases studies →

Lead sponsor

This is the only study on the registry with Urbano Santana Penin, MD, DDS, PhD as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Completely dentate (except for the third molars; including if they were treated before enrollment by conventional or implant-supported fixed prosthesis allowing similar potential comfortable chewing on both sides)
  • Normal Angle Class I occlusion
  • Self-reported pain-intensity scores from 4 to 9 in a 0-10 visual analogue scale (VAS) or numerical pain rating scale (NRS).
  • Chronic (over 6 months) joint and/or muscle pain, according to diagnostic criteria for temporomandibular disorders (DC/TMD), for which they had requested therapy

Exclusion criteria

Exclusion Criteria:

  • Psychosis
  • Major depression
  • Substance abuse
  • Cognitive impairment
  • Addiction to morphine or derivates
  • Litigation or asking for disability/retirement compensation for chronic pain
  • Dental care professionals
  • Orthodontic therapy during the last 2 years
  • Patients with any pain that is more severe, in the same location as, or cannot be clearly distinguished from TMD pain
  • Individuals for whom minimally invasive occlusal adjustment could not achieve occlusal equilibration, including: Over 2 mm of difference between the maximal intercuspal position and the centric occlusion or over 4 mm of difference between upper and lower archs (or over 2mm on at less one side) measured: between the mesial fosses of first upper premolars with respect the buccal cusps of the first lower premolars; and/or between the mesiopalatal cusp of the first upper molars respect to the central (mesial) fossae of the first lower molar.
  • Severe periodontal disease with grade 3 mobility
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
77 participants (actual)

Study arms

  • Experimental
    Occlusal adjustment therapy

    Occlusal adjustment therapy consists of the elimination of premature tooth contacts during retruded jaw closure, and the reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance). A resin-composite, placed mainly in the canine tooth, can be used to increases the flatter lateral guidance on the habitual chewing side; overcorrection is expected to compensate for a masticatory preference on the opposite side to the handedness.

    Procedure: Occlusal adjustment

  • Placebo comparator
    Placebo occlusal adjustment therapy

    Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed.

    Procedure: Placebo occlusal adjustment

Interventions

  • ProcedureOcclusal adjustment

    The first step consists of the elimination of premature tooth contacts during retruded jaw closure. The second step included reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance)

    Also known as: Occlusal reshaping, Selective grinding of teeth, Restoring physiological jaw-closure, Restoring impaired chewing function

  • ProcedurePlacebo occlusal adjustment

    Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed.

06

What researchers measure

Primary outcomes

  1. Jaw-pain-Intensity (Affected Side)

    Self-reported affected-side pain-intensity across the trial in a 0-10 visual analogue scale (VAS) (0=no pain, 10=worst possible pain). Higher values represent a worse outcome.

    Time frame: Baseline and 6-months

Secondary outcomes

  1. Chewing Side

    A consistent chewing side was considered if at lees 5 out of 7 almonds (or at lees 7 of 10 cycles of chewing gum), the participant report to use same side, and same side was used during kinesiography recordings of spontaneous chewing. Any other results lead to alternate chewing allocation.

    Time frame: Baseline and 6-months

  2. Change in Global Severity Index Scores (Symptom Checklist-90-Revised (SCL-90-R))

    Mean change in Global Severity Index scores from a self-administered Spanish validated questionaire SCL-90-R. Higher values represent a worse outcome. Range (0-4).

    Time frame: Baseline, 6-Months

  3. Maximum Unassisted Jaw Opening

    Vertical jaw-opening (incisal level) measured using a ruler. Higher values represent a better outcome.

    Time frame: Baseline, 3- and 6-Months

Other outcomes

  1. Headache-intensity

    Headache intensity in recent months (If any) in a 0-10 numerical pain rating scale with 0=no pain and 10= worst possible pain.

    Time frame: Baseline 3- and 6-Months

  2. Number of Participants With Neuropathic Pain

    Neuropathic pain Questionnaire (DN4). Over 4 scores indicates neuropathic facial pain.

    Time frame: Baseline, 6-Months

  3. Handedness Preference

    Handedness preference assessed using Edinburg inventory: Left Right 1. Writing 2. Drawing 3. Throwing 4. Scissors 5. Toothbrush 6. Knife (without fork) 7. Spoon 8. Broom (upper hand) 9. Striking Match (match) 10. Opening box (lid) I Which foot do you prefer to kick with? II Which eye do you use when using only one?

    Time frame: Baseline

  4. Lateral Guidance Angles (LG)

    The angle between the tangent of the LG tracings and the horizontal Frankfort line, starting from the midsagittal point up 2 mm: using a calibrated Model K7 diagnostic system. Both sides recordings of each patient were measured and considered individually. The mean of both sides of each patient was not used.

    Time frame: Baseline

  5. Condylar Path Angles

    Parasagittal plane condylar path tracings in relation to the Frankfort Horizontal Plane following the Gysi extraoral method.

    Time frame: Baseline

  6. Adverse Events

    Unexpected Adverse Events (NIH, 2009).

    Time frame: After therapy, 1-Month, 3-Months, 6-Months

  7. Jaw Asymmetry

    Over 1 mm of interincisal midline deviation and inter-arches Angle Classification of the lateral sectors (canines and first molars); it will be assessed during maximal intercuspal position and during jaw retruded contact position

    Time frame: Baseline

  8. Participant's Awareness With Trial Group Assignment

    Physicians and patients are quizzed at the end of the study to determine whether or not they have guessed the therapy involved

    Time frame: Six months

  9. Credibility (of Participants)

    Confidence of participants in the goodness of treatment. These items were simplified here to the following single question: How confident would you be that this treatment would be successful in eliminating your pain and/or limited mouth opening? 0-10 numerical rating scale, with 0=nothing to 10= totally.

    Time frame: Baseline, 6-Months

  10. Sociodemography

    Level of education

    Time frame: Baseline

  11. Patient Impression (Improvement)

    Patient impression outcome will be reported as Improved Vs. no change.

    Time frame: 6-Months

  12. Pain Interference on Daily Activity

    In the past 6 months, how much has facial pain interfered with your daily activities rated on a 0-10 scale where 0 is "no interference" and 10 is "unable to carry on any activities"? 0-10 VAS/NRS (0=No interference to 10=Unable to carry on any activities). N.B. Only one item was choose to simplify.

    Time frame: Baseline; 6-Months

  13. Pain-dimensions

    McGill Pain questionnaire

    Time frame: Baseline, 6-Months

  14. Temporomandibular Disorders Related Impairment

    Mandibular Function Impairment Questionnaire (MFIQ)

    Time frame: Baseline, 6-Mo

  15. Circulating Biomarkers

    Blood levels of Circulating Biomarkers

    Time frame: Baseline, 6-Months

  16. Periodontal Disease (if Indicated)

    Radiographic defect, Probing depth, Clinical attachment level, Tooth mobility Tooth mobility

    Time frame: Baseline, 6-Months

  17. Occlusal Forces/Pressure

    Dental or occlusal forces measured using fuji-film method.

    Time frame: Baseline; 6-Months

  18. Maximum Comfortable (Without Pain) Jaw Opening

    Vertical jaw-opening (incisal level) measured using a ruler.

    Time frame: Baseline, immediate after therapy, 3- and 6-Months

  19. Patient's Perception of Reduced Movement

    Subjective patient's perception of reduced jaw-opening; how many fingers can put between your incisors?. Higher values represent a better outcome.

    Time frame: Baseline, 6-Months

  20. Protrusive Motion

    Magnitude (mm) of protrusive jaw-movement (incisal level) and lateral shift (quantitative, mm; and/or qualitative, left/right), using kinesiography recordings. Higher values represent a better outcome.

    Time frame: Baseline, 6-Months

07

Results

Posted Apr 22, 2020

Participant flow

Participant flow — Overall Study
MilestoneOcclusal Adjustmen TherapyPlacebo Occlusal Adjustment Therapy
Started3938
Completed3938
Not completed00

Outcome measures

PrimaryJaw-pain-Intensity (Affected Side)

Self-reported affected-side pain-intensity across the trial in a 0-10 visual analogue scale (VAS) (0=no pain, 10=worst possible pain). Higher values represent a worse outcome.

Time frame:
Baseline and 6-months
Reported as:
Median · units on a scale
Jaw-pain-Intensity (Affected Side)
units on a scaleOcclusal Adjustmen TherapyPlacebo Occlusal Adjustment Therapy
baseline7 (5 to 8)7 (6 to 7)
6-Months2 (0 to 3)3.5 (1 to 6)
SecondaryChewing Side

A consistent chewing side was considered if at lees 5 out of 7 almonds (or at lees 7 of 10 cycles of chewing gum), the participant report to use same side, and same side was used during kinesiography recordings of spontaneous chewing. Any other results lead to alternate chewing allocation.

Time frame:
Baseline and 6-months
Reported as:
Count of participants · Participants
Chewing Side
ParticipantsOcclusal Adjustmen TherapyPlacebo Occlusal Adjustment Therapy
baseline — Right1614
baseline — Alternate813
baseline — Left1511
6-Months — Right66
6-Months — Alternate2527
6-Months — Left85
SecondaryChange in Global Severity Index Scores (Symptom Checklist-90-Revised (SCL-90-R))

Mean change in Global Severity Index scores from a self-administered Spanish validated questionaire SCL-90-R. Higher values represent a worse outcome. Range (0-4).

Time frame:
Baseline, 6-Months
Reported as:
Mean · score on a scale
Change in Global Severity Index Scores (Symptom Checklist-90-Revised (SCL-90-R))
score on a scaleOcclusal Adjustmen TherapyPlacebo Occlusal Adjustment Therapy
baseline0.89 ± 0.570.81 ± 0.51
6-Months0.52 ± 0.50.5 ± 0.49
Statistical analysis
  • Occlusal Adjustmen Therapy vs Placebo Occlusal Adjustment Therapy · Mixed Models Analysis · p = 0.54
SecondaryMaximum Unassisted Jaw Opening

Vertical jaw-opening (incisal level) measured using a ruler. Higher values represent a better outcome.

Time frame:
Baseline, 3- and 6-Months
Reported as:
Mean · mm
Maximum Unassisted Jaw Opening
mmOcclusal Adjustmen TherapyPlacebo Occlusal Adjustment Therapy
baseline41.5 ± 8.443.9 ± 7.8
3-Months45.66 ± 7.946.73 ± 7.7
6-Months47.7 ± 8.446.4 ± 7.7
Other pre-specifiedHeadache-intensity

Headache intensity in recent months (If any) in a 0-10 numerical pain rating scale with 0=no pain and 10= worst possible pain.

Time frame:
Baseline 3- and 6-Months
Reported as:
Median · score on a scale
Headache-intensity
score on a scaleOcclusal Adjustmen TherapyPlacebo Occlusal Adjustment Therapy
baseline7 (5 to 8)5.75 (1 to 7.63)
3-Months4 (1.5 to 6)3 (0.5 to 6)
6-Months4 (0 to 5)3 (0 to 7)
Other pre-specifiedNumber of Participants With Neuropathic Pain

Neuropathic pain Questionnaire (DN4). Over 4 scores indicates neuropathic facial pain.

Time frame:
Baseline, 6-Months
Reported as:
Count of participants · Participants
Number of Participants With Neuropathic Pain
ParticipantsOcclusal Adjustmen TherapyPlacebo Occlusal Adjustment Therapy
baseline — neuropathic pain1312
baseline — without neuropathic symptoms2625
at month 6 — neuropathic pain34
at month 6 — without neuropathic symptoms3633
Other pre-specifiedHandedness Preference

Handedness preference assessed using Edinburg inventory: Left Right 1. Writing 2. Drawing 3. Throwing 4. Scissors 5. Toothbrush 6. Knife (without fork) 7. Spoon 8. Broom (upper hand) 9. Striking Match (match) 10. Opening box (lid) I Which foot do you prefer to kick with? II Which eye do you use when using only one?

Time frame:
Baseline
Reported as:
Count of participants · Participants
Handedness Preference
ParticipantsOcclusal Adjustmen TherapyPlacebo Occlusal Adjustment Therapy
right2931
left107
Other pre-specifiedLateral Guidance Angles (LG)

The angle between the tangent of the LG tracings and the horizontal Frankfort line, starting from the midsagittal point up 2 mm: using a calibrated Model K7 diagnostic system. Both sides recordings of each patient were measured and considered individually. The mean of both sides of each patient was not used.

Time frame:
Baseline
Reported as:
Mean · degrees
Lateral Guidance Angles (LG)
degreesOcclusal Adjustmen TherapyPlacebo Occlusal Adjustment Therapy
Lateral Guidance Angles (LG)42 ± 10.340.6 ± 11.8
Other pre-specifiedCondylar Path Angles

Parasagittal plane condylar path tracings in relation to the Frankfort Horizontal Plane following the Gysi extraoral method.

Time frame:
Baseline
Reported as:
Mean · degrees
Condylar Path Angles
degreesOcclusal Adjustmen TherapyPlacebo Occlusal Adjustment Therapy
right joint50.5 ± 10.747.3 ± 8.1
left joint50.1 ± 10.549.3 ± 8.6
Other pre-specifiedAdverse Events

Unexpected Adverse Events (NIH, 2009).

Time frame:
After therapy, 1-Month, 3-Months, 6-Months
Reported as:
Count of participants · Participants
Adverse Events
ParticipantsOcclusal Adjustmen TherapyPlacebo Occlusal Adjustment Therapy
Adverse Events00
Other pre-specifiedJaw Asymmetry

Over 1 mm of interincisal midline deviation and inter-arches Angle Classification of the lateral sectors (canines and first molars); it will be assessed during maximal intercuspal position and during jaw retruded contact position

Time frame:
Baseline

Results for this outcome have not been posted.

Other pre-specifiedParticipant's Awareness With Trial Group Assignment

Physicians and patients are quizzed at the end of the study to determine whether or not they have guessed the therapy involved

Time frame:
Six months
Reported as:
Count of participants · Participants
Participant's Awareness With Trial Group Assignment
ParticipantsOcclusal Adjustmen TherapyPlacebo Occlusal Adjustment Therapy
real therapy2621
I don't' know1214
placebo therapy13
Other pre-specifiedCredibility (of Participants)

Confidence of participants in the goodness of treatment. These items were simplified here to the following single question: How confident would you be that this treatment would be successful in eliminating your pain and/or limited mouth opening? 0-10 numerical rating scale, with 0=nothing to 10= totally.

Time frame:
Baseline, 6-Months
Reported as:
Mean · units on a scale
Credibility (of Participants)
units on a scaleOcclusal Adjustmen TherapyPlacebo Occlusal Adjustment Therapy
baseline8 ± 1.88.3 ± 1.3
6-Months8 ± 1.97.6 ± 2.6
Other pre-specifiedSociodemography

Level of education

Time frame:
Baseline
Reported as:
Count of participants · Participants
Sociodemography
ParticipantsOcclusal Adjustmen TherapyPlacebo Occlusal Adjustment Therapy
Higher2126
Secondary129
No qualifications63
Other pre-specifiedPatient Impression (Improvement)

Patient impression outcome will be reported as Improved Vs. no change.

Time frame:
6-Months
Reported as:
Count of participants · Participants
Patient Impression (Improvement)
ParticipantsOcclusal Adjustmen TherapyPlacebo Occlusal Adjustment Therapy
Improved3725
No change211
Other pre-specifiedPain Interference on Daily Activity

In the past 6 months, how much has facial pain interfered with your daily activities rated on a 0-10 scale where 0 is "no interference" and 10 is "unable to carry on any activities"? 0-10 VAS/NRS (0=No interference to 10=Unable to carry on any activities). N.B. Only one item was choose to simplify.

Time frame:
Baseline; 6-Months
Reported as:
Mean · units on a scale
Pain Interference on Daily Activity
units on a scaleOcclusal Adjustmen TherapyPlacebo Occlusal Adjustment Therapy
baseline5.2 ± 2.64.5 ± 2.9
6-Months3.1 ± 2.62 ± 3.2
Other pre-specifiedPain-dimensions

McGill Pain questionnaire

Time frame:
Baseline, 6-Months

Results for this outcome have not been posted.

Other pre-specifiedTemporomandibular Disorders Related Impairment

Mandibular Function Impairment Questionnaire (MFIQ)

Time frame:
Baseline, 6-Mo

Results for this outcome have not been posted.

Other pre-specifiedCirculating Biomarkers

Blood levels of Circulating Biomarkers

Time frame:
Baseline, 6-Months

Results for this outcome have not been posted.

Other pre-specifiedPeriodontal Disease (if Indicated)

Radiographic defect, Probing depth, Clinical attachment level, Tooth mobility Tooth mobility

Time frame:
Baseline, 6-Months

Results for this outcome have not been posted.

Other pre-specifiedOcclusal Forces/Pressure

Dental or occlusal forces measured using fuji-film method.

Time frame:
Baseline; 6-Months

Results for this outcome have not been posted.

Other pre-specifiedMaximum Comfortable (Without Pain) Jaw Opening

Vertical jaw-opening (incisal level) measured using a ruler.

Time frame:
Baseline, immediate after therapy, 3- and 6-Months

Results for this outcome have not been posted.

Other pre-specifiedPatient's Perception of Reduced Movement

Subjective patient's perception of reduced jaw-opening; how many fingers can put between your incisors?. Higher values represent a better outcome.

Time frame:
Baseline, 6-Months

Results for this outcome have not been posted.

Other pre-specifiedProtrusive Motion

Magnitude (mm) of protrusive jaw-movement (incisal level) and lateral shift (quantitative, mm; and/or qualitative, left/right), using kinesiography recordings. Higher values represent a better outcome.

Time frame:
Baseline, 6-Months

Results for this outcome have not been posted.

Adverse events

Collected over 6 months. Non-serious events are listed at a 3% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Occlusal Adjustmen Therapy0/39 (0%)0/39 (0%)3/39 (7.7%)
Placebo Occlusal Adjustment Therapy0/38 (0%)0/38 (0%)0/38 (0%)
Most frequent other events
Most frequent other events
EventOcclusal Adjustmen TherapyPlacebo Occlusal Adjustment Therapy
Dental hypersensitivityMusculoskeletal and connective tissue disorders3/390/38

Baseline characteristics

Age, Continuous
Age, Continuous(years)Occlusal Adjustmen TherapyPlacebo Occlusal Adjustment TherapyTotal
Median29 (22 to 38)30 (25 to 40)30 (24 to 40)
Sex: Female, Male
Sex: Female, Male(Participants)Occlusal Adjustmen TherapyPlacebo Occlusal Adjustment TherapyTotal
Female373572
Male235
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Occlusal Adjustmen TherapyPlacebo Occlusal Adjustment TherapyTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American123
White383674
More than one race000
Unknown or Not Reported000
Self-reported jaw-pain intensity
Self-reported jaw-pain intensity(units on a 0-10 scale)Occlusal Adjustmen TherapyPlacebo Occlusal Adjustment TherapyTotal
Median7 (5 to 8)7 (6 to 7)7 (6 to 7)
08

Study locations

2 sites
  • Universidad de Santiago de Compostela
    Santiago de Compostela, A Coruña, Galicia 15782, Spain
  • Complexo Hospitalario Universitario A Coruña
    A Coruña, A Coruña. Galicia 15006, Spain
09

References and documents

Publications

  • Santana-Mora U, Lopez-Cedrun J, Mora MJ, Otero XL, Santana-Penin U. Temporomandibular disorders: the habitual chewing side syndrome. PLoS One. 2013 Apr 8;8(4):e59980. doi: 10.1371/journal.pone.0059980. Print 2013. PubMed 23593156 ↗

Study documents

  • Protocol and statistical analysis plan · Mar 1, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — A closed, certificate, database called OpenClinica allows access to members of the Data and Safety Monitoring Board. We expect to publish raw data in Sci Data. Figures from participant's mouth could be posted in a repository. The protocol will be attached as a supplementary appendix to the main manuscript

Supporting information: Study protocol, Sap, Icf

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 22, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02144233
Lead sponsor
Urbano Santana Penin, MD, DDS, PhD
Collaborators
University of Santiago de Compostela
Responsible party
Urbano Santana Penin, MD, DDS, PhD (Prof., University of Santiago de Compostela) — Sponsor-investigator
First posted
May 21, 2014
Start date
Aug 2014
Primary completion
Jun 15, 2018
Completion
Jun 15, 2018
Results posted
Apr 22, 2020
Last update
Apr 22, 2020

Study contacts

Urbano Santana-Penin, Prof
principal investigator · University of Santiago de Compostela
Jose Lopez-Cedrun, Dr
study chair · University Hospital Complex of La Coruña
Maria J Mora, Prof
study director · University of Santiago de Compostela
Urbano Santana-Mora, Dr
principal investigator · University of Santiago de Compostela

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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