CClinicalTrials.gg
RecruitingNCT06685016Updated Nov 14, 2024

Evaluation of Dental and Periodontal Health After IPR in Patients in Orthodontic Treatment With Clear Aligners

An interventional study of Evaluation of Dentin hypersensitivity with VAS scale in Dentinal Hypersensitivity, Plaque, Dental and Bleeding Gum, sponsored by University of Campania Luigi Vanvitelli. Recruiting at 1 site in Italy. Open to participants aged 17 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-14.

Sponsored by University of Campania Luigi Vanvitelli · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as recruiting.
  • Registered 1 year 4 months after the study started (first participant enrolled Jun 2023, registered Nov 2024).
  • Started Jun 2023; still recruiting 3 years 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
17 Years to 100 Years
Sex
All
01

Study summary

This study aimed to evaluate dental and periodontal health after interproximal enamel reduction and to compare Laser diode (a device used in the Orthodontic Program) and sodium fluoride (often used in the Orthodontic Program and in the Material Dental Program). The hypothesis was that the intervention groups would show a lower dentin hypersensitivity incidence than the control group during orthodontic treatment.

Read the detailed description

Interproximal enamel reduction (IPR) is a common procedure used during orthodontic treatment aimed to reduce mesio-distal tooth size dimensions to address lack of space (mild and moderate crowding), Bolton tooth-size discrepancy, correction of morphologic anomalies, tooth reshaping and management of gingival papilla. It is a practice that also offers an attractive alternative to overcome difficulty when extracting premolars and resolve the instability of overexpansion in non- extraction cases, improving the stability of the arches.

IPR may be exploited inconjunction with fixed appliance treatment, although its application with removable appliance treatment such as clear aligners is commonplace.

Clinically, the most accepted IPR techniques include air-rotor stripping with fine tungsten-carbide or diamond burs, handpiece or contra-angle-mounted diamond-coated disks, and handheld or motor- driven abrasive metal strips.

Some of these techniques can cause deep furrows and scratches that cannot be removed by polishing . In addition, these surface irregularities could promote the adherence of plaque bacteria and induce iatrogenic damage, such as dental caries, gingival inflammation, periodontal tissue breakdown, gingival recession and increased sensitivity of the shaped teeth to hot and cold temperatures.

Sometimes, after IPR, it is possible to have dentin hypersensitivity (DH), attributed to exposure to dentinal tubules. This clinical condition is influenced by various factors, including patient' s age, the severity of crowding, pathological tooth wear, hypersensitivity before treatment and the amount of the removed enamel.

DH can be defined as "short and sharp pain due to exposure of the dentinal tubules in response to thermal, evaporative, tactile, osmotic or chemical stimuli". The hydrodynamic theory proposed by Brännström is the most accepted theory to explain the DH mechanism. According to this theory, external stimuli, leading to fluid movement within the dentinal tubules and this movement indirectly stimulates the pulp nerve ends, causing a painful sensation.

Several methods can perform DH treatment. Based on the mode of their administration, the desensitizing treatment can be classified into at-home therapy or in-office therapy categories. At- home desensitizing products include toothpaste, mouthwashes and chewing gums. In contrast, in- office desensitizing products can be gels, solutions, varnishes, resin sealers, glass ionomers, dentin adhesives and more sophisticated laser techniques. In addition, eliminating of nociceptive stimuli, there are two main treatment strategies: modifying nervous response by preventing or reducing neuronal transmission and occluding the permeable dentinal tubules.

Potassium salts were thought to decrease the excitability of pulpal nerves and result in a reduction in DH. Still, clinical trials with sound design have failed to provide evidence that potassium is effective in desensitizing teeth. Potassium salts likely reduced the perception of dentin sensitivity through a placebo effect. The proposed mechanism for glutaraldehyde, another agent used for the treatment of DH, involves the reaction with serum albumin in dentinal tubule fluid, leading to precipitate formation within tubules and subsequent narrowing or blocking of the tubules. Strontium salts, fluoride, oxalate and arginine/calcium can occlude the tubules and form a protective layer on the dentin surface. Dental adhesives and resin sealants can occlude the dentinal tubules by forming a physical barrier thus blocking the movement of dentinal fluid and preventing direct stimulation of odontoblastic processes. The action of glass ionomers in the management of DH can also lead to occlusion of open dentinal tubules by precipitating a hydroxycarbonate apatite layer over the previously patent tubule openings. Laser treatment has been investigated as a prospective treatment for DH. Several studies suggest that the low-power laser could suppress the excitability of the pulpal nerves. Higher output laser is thought to reduce symptoms of DH by inducing the occlusion of dentin tubules.

Pain associated with DH may reduce the quality of life, but does not compromise people's health. Currently, no studies that have tested desensitizing substances to reduce or eliminate DH that can occur after IPR.

02

Conditions studied

  • Dentinal Hypersensitivity
  • Plaque, Dental
  • Bleeding Gum

Keywords

  • Clear Aligners
  • Interproximal enamel reduction
03

In context

Dental Plaque

314 studies on the registry are indexed under Dental Plaque; 55 are open to participants now.

This study's planned enrollment of 30 is below the median of 59 across 279 interventional studies indexed under Dental Plaque.

Browse Dental Plaque studies →

Lead sponsor

University of Campania Luigi Vanvitelli is the lead sponsor of 170 studies on the registry; 26 are open to participants now.

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

04

Who can participate

Ages eligible
17 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • to be in orthodontic treatment with clear aligners and this treatment requires interproximal enamel reduction;
  • permanent dentition;
  • good oral and periodontal health.

Exclusion criteria

Exclusion Criteria:

  • enamel defects;
  • cervical caries;
  • periodontal disease;
  • history of trauma or craniofacial anomalies;
  • pregnancy.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Control Group

    Subjects will not receive any treatment

    Diagnostic Test: Evaluation of Dentin hypersensitivity with VAS scale

  • Experimental
    Laser Diode Group

    Subjects treated with Laser Diode

    Diagnostic Test: Evaluation of Dentin hypersensitivity with VAS scale

  • Experimental
    Sodium Fluoride Group

    Subjects with a sodium fluoride gel treatment.

    Diagnostic Test: Evaluation of Dentin hypersensitivity with VAS scale

Interventions

  • Diagnostic testEvaluation of Dentin hypersensitivity with VAS scale

    Dentin hypersensitivity and periodontal indices evaluation are performed after and before IPR, at 1 week, 1 month and 3 months

06

What researchers measure

Primary outcomes

  1. Assestment of DH after IPR

    Dentin hypersensitivity will be assessed before and after interproximal enamel reduction and after the application of therapeutic protocols. Dentin hypersensitivity will be performed with the evaporative method. After isolation of the adjacent teeth, the air syringe will be placed 2-3 mm from the tooth surface, at a perpendicular position of 90º, and a continuous air blast of 45 to 60 psi (3.10 to 4.13 Bar) should be applied for 2-3 seconds. The air temperature should be around 20°C (19-22°C). The discomfort will be expressed in a numerical 0-10 cm visual analog scale (VAS) where the value 0 is correlated with no discomfort and the value 10 for utmost discomfort or intolerable pain during application of the stimulus. Each patient will place a vertical mark on the VAS to indicate the intensity of his or her level of sensitivity after the applied stimuli.

    Time frame: from 3 to 4 months

  2. Reduction of the Dentin Hypersensitivity

    . Dentin hypersensitivity will be performed with the evaporative method. After isolation of the adjacent teeth, the air syringe will be placed 2-3 mm from the tooth surface, at a perpendicular position of 90º, and a continuous air blast of 45 to 60 psi (3.10 to 4.13 Bar) should be applied for 2-3 seconds. The air temperature should be around 20°C (19-22°C). The discomfort will be expressed in a numerical 0-10 cm visual analog scale (VAS) where the value 0 is correlated with no discomfort and the value 10 for utmost discomfort or intolerable pain during application of the stimulus. Each patient will place a vertical mark on the VAS to indicate the intensity of his or her level of sensitivity after the applied stimuli.

    Time frame: from 3 to 4 months

Secondary outcomes

  1. Evaluation of Dentin hypersensitivity after the application of therapeutic protocols.

    Evaluate Dentin Hypersensitivity in the control group and the treated groups,with the evaporative method. After isolation of the adjacent teeth, the air syringe will be placed 2-3 mm from the tooth surface, at a perpendicular position of 90º, and a continuous air blast of 45 to 60 psi (3.10 to 4.13 Bar) should be applied for 2-3 seconds. The air temperature should be around 20°C (19-22°C). The discomfort will be expressed in a numerical 0-10 cm visual analog scale (VAS) where the value 0 is correlated with no discomfort and the value 10 for utmost discomfort or intolerable pain during application of the stimulus. Each patient will place a vertical mark on the VAS to indicate the intensity of his or her level of sensitivity after the applied stimuli. To assess in which group it reduces or is eliminated more quickly.

    Time frame: from 3 to 4 months

07

Study locations

1 of 1 sites recruiting
  • Multidisciplinary department of Medical-Surgical and Dental Specialties
    Naples, 80138, Italy
    Recruiting
08

References and documents

Publications

  • Liu XX, Tenenbaum HC, Wilder RS, Quock R, Hewlett ER, Ren YF. Pathogenesis, diagnosis and management of dentin hypersensitivity: an evidence-based overview for dental practitioners. BMC Oral Health. 2020 Aug 6;20(1):220. doi: 10.1186/s12903-020-01199-z. PubMed 32762733 ↗
  • Poulsen S, Errboe M, Lescay Mevil Y, Glenny AM. Potassium containing toothpastes for dentine hypersensitivity. Cochrane Database Syst Rev. 2006 Jul 19;2006(3):CD001476. doi: 10.1002/14651858.CD001476.pub2. PubMed 16855970 ↗
  • Orchardson R, Gillam DG. The efficacy of potassium salts as agents for treating dentin hypersensitivity. J Orofac Pain. 2000 Winter;14(1):9-19. PubMed 11203743 ↗
  • Livas C, Jongsma AC, Ren Y. Enamel reduction techniques in orthodontics: a literature review. Open Dent J. 2013 Oct 31;7:146-51. doi: 10.2174/1874210601307010146. eCollection 2013. PubMed 24265652 ↗
  • Boyd RL. Esthetic orthodontic treatment using the invisalign appliance for moderate to complex malocclusions. J Dent Educ. 2008 Aug;72(8):948-67. PubMed 18676803 ↗
  • Pindoria J, Fleming PS, Sharma PK. Inter-proximal enamel reduction in contemporary orthodontics. Br Dent J. 2016 Dec 16;221(12):757-763. doi: 10.1038/sj.bdj.2016.945. PubMed 27982013 ↗
  • Lombardo L, Guarneri MP, D'Amico P, Molinari C, Meddis V, Carlucci A, Siciliani G. Orthofile(R): a new approach for mechanical interproximal reduction : a scanning electron microscopic enamel evaluation. J Orofac Orthop. 2014 May;75(3):203-12. doi: 10.1007/s00056-014-0213-0. Epub 2014 May 15. PubMed 24825832 ↗
  • Joseph VP, Rossouw PE, Basson NJ. Orthodontic microabrasive reproximation. Am J Orthod Dentofacial Orthop. 1992 Oct;102(4):351-9. doi: 10.1016/0889-5406(92)70051-B. PubMed 1333728 ↗
  • Zachrisson BU. Actual damage to teeth and periodontal tissues with mesiodistal enamel reduction ("stripping"). World J Orthod. 2004 Summer;5(2):178-83. No abstract available. PubMed 15615137 ↗
  • Jarjoura K, Gagnon G, Nieberg L. Caries risk after interproximal enamel reduction. Am J Orthod Dentofacial Orthop. 2006 Jul;130(1):26-30. doi: 10.1016/j.ajodo.2004.08.024. PubMed 16849068 ↗
  • Lapenaite E, Lopatiene K. Interproximal enamel reduction as a part of orthodontic treatment. Stomatologija. 2014;16(1):19-24. PubMed 24824056 ↗
  • Marto CM, Baptista Paula A, Nunes T, Pimenta M, Abrantes AM, Pires AS, Laranjo M, Coelho A, Donato H, Botelho MF, Marques Ferreira M, Carrilho E. Evaluation of the efficacy of dentin hypersensitivity treatments-A systematic review and follow-up analysis. J Oral Rehabil. 2019 Oct;46(10):952-990. doi: 10.1111/joor.12842. Epub 2019 Jul 12. PubMed 31216069 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 14, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06685016
Lead sponsor
University of Campania Luigi Vanvitelli
Responsible party
Vincenzo Grassia (Associate Professor, University of Campania Luigi Vanvitelli) — Principal investigator
First posted
Nov 12, 2024
Start date
Jun 24, 2023
Primary completion
Dec 2024 (estimated)
Completion
Dec 2024 (estimated)
Last update
Nov 14, 2024

Study contacts

Vincenzo Grassia, DDs,PhD
Contact
vincenzo.grassia@unicampania.it
+39 0815665524
Vincenzo Grassia, DDs,PhD
principal investigator · University of Campania Luigi Vanvitelli

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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