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CompletedNCT02625298Updated Sep 27, 2017Results posted

Use of Mineral Trioxide Aggregate in the Treatment of Traumatized Teeth

A Phase 2 interventional study of ProRoot MTA and MTA+ Cerkamed in Periapical Diseases, sponsored by Association of Paediatric and Preventive Dentists of Serbia. Completed. Open to participants aged 7 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-27.

Sponsored by Association of Paediatric and Preventive Dentists of Serbia · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
7 Years to 18 Years
Sex
All
01

Study summary

Traumatic tooth injuries are common in children and adolescents, and often result in pulpal necrosis and the development of periapical lesions. Treatment of traumatized teeth with endodontic complications depends on the type of injury, number of injured teeth, root development and patient cooperation, which altogether will create a challenge and dictate the treatment plan for the dentist. The purpose of this study was to assess the effectiveness of non-surgical root canal procedures in traumatized permanent teeth with necrotic pulps and chronic periapical lesions using a tri-antibiotic paste and calcium-hydroxide as intracanal medications and two different mineral trioxide aggregate (MTA) products for definitive obturation.

Read the detailed description

Root canal procedures will be performed on single-rooted traumatized permanent teeth (both with mature and immature root development) with necrotic pulps and periaoical lesions. Following access opening in each tooth, the root canals will be gently debrided with a crown-down manual technique using K-files according to the radiographically determined working lengths; irrigation with saline was used in all cases. K-files will be only used to remove the necrotic tissue and the softened predentinal layer without excessive removal of mineralized dentin, as this may have further weaken already thin walls of the root canals, particularly those with immature apical development. Subsequently, a reshaping of the canal system, followed by a minor curettage of the periapical area through the canal using barbed broaches will be made in order to partially destruct the periapical lesion and provoke bleeding. Final irrigation will be performed using 2% NaOCl (Chloraxid, Cerkamed, Stalowa Wola-Poland), 0.2% solution of chlorhexidine-digluconate (Curasept 220, Curadent Swiss GmbH, Kriens-Switzerland) and 40% citric acid solution (40% Citric acid, Cerkamed, Stalowa Wola, Poland). The canals will be then dried with sterile paper points and filled with triple-antibiotics paste using a lentula, for a period of seven days. Following this initial disinfection, calcium-hydroxide paste will be placed into the root canals for at least four weeks, for a maximum of six weeks (UltraCal XS, Ultradent Products Inc., South Jordan, UT USA). Apical thirds of the root canals will be obturated either with ProRoot MTA (Dentsply Tulsa Dental Specialties, Tulsa, OK USA) or MTA+ Cerkamed (Cerkamed, Stalowa Wola, Poland) by forming an apical plug of 3-5 mm of thickness. The correct placement of the apical plug will be assessed radiographically, and the moist cotton pellet was left in the root canal. The next day, the rest of the canal space will be filled with a sealer (Acroseal, Septodont, Saint-Maur des Frosses-France) and gutta-percha points (Guttapercha, VDW GmbH, Munich-Germany) using a lateral compaction technique. Coronal parts of root canal systems will be sealed using glass-ionomer cement (Fuji IX, GC Int., Tokyo, Japan) with a minimum thickness of 1.5-2 mm. The teeth will be restored using composite material (Gradia Direct, GC Int., Tokyo, Japan). Two dentists with many years of clinical experience, and using identical, predetermined treatment protocols will perform all treatments.

The positive clinical outcome will comprise of absence of spontaneous or provoked pain, no discomfort during chewing, no numbness or tenderness to percussion and/or palpation, no altered tooth mobility, tooth crown discoloration or abscess and/or sinus tract. Radiological assessment of the outcomes will be performed according to the analysis of post treatment radiographs (initial, baseline, 3, 6, 12, and 24-months subsequent to obturation) after being photographed using a digital camera Kodak EasyShare Max (Z990) with millimetre measurer in order to obtain interpretation of sizes of periapical lesions during conversion of pixels in mm2 by digital data processing in Adobe Photoshop CS software.

02

Conditions studied

  • Periapical Diseases

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Keywords

  • periapical diseases
  • dental injuries
  • MTA
03

In context

Periapical Diseases

44 studies on the registry are indexed under Periapical Diseases; 12 are open to participants now.

This study's enrollment of 24 is below the median of 60 across 35 interventional studies indexed under Periapical Diseases.

Browse Periapical Diseases studies →

Lead sponsor

Association of Paediatric and Preventive Dentists of Serbia is the lead sponsor of 3 studies on the registry; none are open to participants now.

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

04

Who can participate

Ages eligible
7 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy patient
  • Non-vital tooth with chronic periapical lesions
  • Restorable tooth
  • No horizontal or vertical root fractures
  • No root resorption

Exclusion criteria

Exclusion Criteria:

  • Unrestorable tooth
  • Horizontal or vertical root fractures
  • Root resorption
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    ProRoot MTA

    Traumatized permanent teeth obturated with ProRoot MTA after root canal treatment

    Device: ProRoot MTA

  • Experimental
    MTA+ Cercamed

    Traumatized permanent teeth obturated with MTA+ Cerkamed after root canal treatment

    Device: MTA+ Cerkamed

Interventions

  • DeviceProRoot MTA

    Apical thirds of the root canals obturated with ProRoot MTA (Dentsply Tulsa Dental Specialties, Tulsa, OK USA).

  • DeviceMTA+ Cerkamed

    Apical thirds of the root canals obturated with MTA + (Cerkamed, Stalowa Wola, Poland).

06

What researchers measure

Primary outcomes

  1. Changes Between Initial and Post Treatment Dimensions of Periapical Lesions

    Changes in the dimensions of periapical lesions will be performed according to the analysis of initial and post treatment radiographs (baseline, 3, 6, 12, and 24-months subsequent to obturation) after being photographed using a digital camera Kodak EasyShare Max (Z990) with millimetre measurer in order to obtain interpretation of sizes of periapical lesions during conversion of pixels in mm2 by digital data processing in Adobe Photoshop CS software. Sucessful radiographic assessment will include decrease in size of the periapical lesion at the recall time of 24 months.

    Time frame: baseline, 3, 6, 12 and 24 months

Secondary outcomes

  1. Presence of Clinical Symptoms

    Clinical examination will be used to assess the presence of spontaneous or provoked pain, discomfort during chewing, numbness or tenderness to percussion and/or palpation, altered tooth mobility, tooth crown discoloration or abscess and/or sinus tract.

    Time frame: baseline

07

Results

Posted Jul 25, 2017

Participant flow

The study involved twenty-four patients, 11 males (45.8%) and 13 females (54.2%) (mean age 13.30±2.83), who came to the University Clinic, due to spontaneous or provoked pain, discomfort during chewing, numbness, and observed swelling.

Participant flow — Overall Study
MilestoneProRoot MTAMTA+ Cercamed
Started1113
Completed1013
Not completed10

Outcome measures

PrimaryChanges Between Initial and Post Treatment Dimensions of Periapical Lesions

Changes in the dimensions of periapical lesions will be performed according to the analysis of initial and post treatment radiographs (baseline, 3, 6, 12, and 24-months subsequent to obturation) after being photographed using a digital camera Kodak EasyShare Max (Z990) with millimetre measurer in order to obtain interpretation of sizes of periapical lesions during conversion of pixels in mm2 by digital data processing in Adobe Photoshop CS software. Sucessful radiographic assessment will include decrease in size of the periapical lesion at the recall time of 24 months.

Time frame:
baseline, 3, 6, 12 and 24 months
Reported as:
Mean · square millimeters
Changes Between Initial and Post Treatment Dimensions of Periapical Lesions
square millimetersProRoot MTAMTA+ Cercamed
Initial37.34 ± 0.6334.04 ± 0.34
Baseline16.20 ± 0.2117.54 ± 0.75
3 months12.74 ± 0.1912.01 ± 0.34
6 months11.59 ± 0.257.86 ± 0.23
12 months8.38 ± 0.104.85 ± 0.24
24 months2.99 ± 0.102.48 ± 0.10
Statistical analysis
  • ProRoot MTA vs MTA+ Cercamed · Mixed Models Analysis · p = <0.01
SecondaryPresence of Clinical Symptoms

Clinical examination will be used to assess the presence of spontaneous or provoked pain, discomfort during chewing, numbness or tenderness to percussion and/or palpation, altered tooth mobility, tooth crown discoloration or abscess and/or sinus tract.

Time frame:
baseline
Reported as:
Number · participants
Presence of Clinical Symptoms
participantsProRoot MTAMTA+ Cercamed
spontaneous or provoked pain55
discomfort during chewing86
numbness31
tenderness to percussion and/or palpation22
altered tooth mobility21
tooth crown discoloration11
abscess and/or sinus tract10

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
ProRoot MTA——0/11 (0%)
MTA+ Cercamed——0/13 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(tooth)ProRoot MTAMTA+ CercamedTotal
<=18 years141327
Between 18 and 65 years000
>=65 years000
Sex: Female, Male
Sex: Female, Male(Participants)ProRoot MTAMTA+ CercamedTotal
Female6713
Male5611
Region of Enrollment
Region of Enrollment(tooth)ProRoot MTAMTA+ CercamedTotal
Serbia141327
08

Study locations

No study locations are listed for this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 27, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02625298
Lead sponsor
Association of Paediatric and Preventive Dentists of Serbia
Responsible party
Dejan Markovic (Professor, Association of Paediatric and Preventive Dentists of Serbia) — Principal investigator
First posted
Dec 9, 2015
Start date
Sep 2010
Primary completion
Dec 2015
Completion
Mar 2016
Results posted
Jul 25, 2017
Last update
Sep 27, 2017

Oversight

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

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This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

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