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

NCT06685016 | Recruiting

• 1 other identifier: 0016945/i
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dentinal Hypersensitivity; Plaque, Dental; Bleeding Gum

Keywords

Clear Aligners; Interproximal enamel reduction

Outcome Measures

Primary Outcomes (2)

• 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.

  from 3 to 4 months

• 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.

  from 3 to 4 months

Secondary Outcomes (1)

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

  from 3 to 4 months

Study Arms (3)

Control Group

EXPERIMENTAL

Subjects will not receive any treatment

Diagnostic Test: Evaluation of Dentin hypersensitivity with VAS scale

Laser Diode Group

EXPERIMENTAL

Subjects treated with Laser Diode

Diagnostic Test: Evaluation of Dentin hypersensitivity with VAS scale

Sodium Fluoride Group

EXPERIMENTAL

Subjects with a sodium fluoride gel treatment.

Diagnostic Test: Evaluation of Dentin hypersensitivity with VAS scale

Interventions

Evaluation of Dentin hypersensitivity with VAS scale DIAGNOSTIC_TEST

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

Control Group; Laser Diode Group; Sodium Fluoride Group

Eligibility Criteria

• Age: 17 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Study Sites (1)

Multidisciplinary department of Medical-Surgical and Dental Specialties

Naples, 80138, Italy

RECRUITING

Related Publications (12)

• 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.

  PMID: 32762733 BACKGROUND

• 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.

  PMID: 16855970 BACKGROUND

• Orchardson R, Gillam DG. The efficacy of potassium salts as agents for treating dentin hypersensitivity. J Orofac Pain. 2000 Winter;14(1):9-19.

  PMID: 11203743 BACKGROUND

• 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.

  PMID: 24265652 BACKGROUND

• Boyd RL. Esthetic orthodontic treatment using the invisalign appliance for moderate to complex malocclusions. J Dent Educ. 2008 Aug;72(8):948-67.

  PMID: 18676803 BACKGROUND

• 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.

  PMID: 27982013 BACKGROUND

• 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.

  PMID: 24825832 BACKGROUND

• 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.

  PMID: 1333728 BACKGROUND

• 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.

  PMID: 15615137 BACKGROUND

• 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.

  PMID: 16849068 BACKGROUND

• Lapenaite E, Lopatiene K. Interproximal enamel reduction as a part of orthodontic treatment. Stomatologija. 2014;16(1):19-24.

  PMID: 24824056 BACKGROUND

• 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.

  PMID: 31216069 BACKGROUND

MeSH Terms

Conditions

Dental Plaque; Gingival Hemorrhage

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases; Oral Hemorrhage; Mouth Diseases; Gingival Diseases; Periodontal Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Vincenzo Grassia, DDs,PhD

  University of Campania Luigi Vanvitelli

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vincenzo Grassia, DDs,PhD

CONTACT

+39 0815665524; vincenzo.grassia@unicampania.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: November 12, 2024
• Study Start: June 24, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: November 14, 2024

Record last verified: 2024-11

Locations

IT (1)