Comparison of Oral Hygiene & Root Resorption During Orthodontic Treatment

NCT02745626 | Completed Results

• 1 other identifier: IRB No. 12-025-2
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

Orthodontic treatment has been traditionally carried out with fixed appliances involving the use of stainless steel brackets and archwires. The challenge has been to move teeth and their roots effectively while minimizing iatrogenic damage such as root resorption and gingival inflammation. In recent years, with the development of new appliances and brackets such as self-ligating brackets and clear aligners there have been reports of improved periodontal status, less iatrogenic root damage and improved hygiene during treatment. Although these treatment modalities have been rapidly accepted in clinical practice, both clinical and basic science research data regarding their overall biological compatibility to support higher levels of evidence based dentistry (e.g, randomized clinical trials) is lacking. In other words, their advantages and disadvantages in this regard have not yet been scientifically evaluated. Such quantification will provide invaluable information for improvements in these treatment modalities. A randomized controlled clinical trial will be conducted with strict inclusion and exclusion criteria to test the following hypothesis (H) up to 18 months into treatment: H-1: There is no difference in the amount of root resorption caused by the three different appliances. H-2: Gingival health is not affected by the 'type of appliance' being used to correct the malocclusion. H-3: There is no difference in the amount of bacterial count and the type of appliance being used for orthodontic treatment. The hypothesis will be tested with the following specific aims (SA): SA-1: To investigate the amount of orthodontically induced inflammatory root resorption generated by treatment. SA-2: To evaluate the periodontal health of the patients with the different appliance systems. SA-3: To determine the changes in Streptococcus mutans and total bacterial counts contained in the plaque of orthodontic patients. SA-4: To ascertain whether there is an association between the microbial count and the type of appliance being used for orthodontic treatment

Conditions

Orthodontic Pathological Resorption of External Root; Complication of Personal Oral Hygiene

Outcome Measures

Primary Outcomes (1)

• Plaque Index

  A measure of the plaque levels on the desired tooth surface. The following scores were used: 0 no plaque/debris on inspection and probing 1. thin film of plaque only visible after probing 2. ribbon-like layer of plaque covering the sulcus \& gingival crown areas but not filling interdental space 3. thick layer of plaque already visible at inspection and filling interdental space

  T0: Before treatment; T1: 9 months of treatment; T2: 18 months of treatment

Secondary Outcomes (6)

• Gingival Index

  T0: Before treatment; T1: 9 months of treatment; T2: 18 months of treatment

• Bleeding Index

  T0: Before treatment; T1: 9 months of treatment; T2: 18 months of treatment

• Total Bacterial Count

  T0: Before treatment; T1: 9 months of treatment; T2: 18 months of treatment

• S.Mutans Count

  T0: Before treatment; T1: 9 months of treatment; T2: 18 months of treatment

• Amount of Root Resorption Observed for Maxillary Lateral Incisor = Length of Root at T0-Length of Root at T2 (in mm)

  T0-T2: 18 months of treatment

Study Arms (3)

Clear Aligner Appliance

EXPERIMENTAL

Clear Aligners, Align Technology Inc., Santa Clara, California

Device: Appliance

Self-ligating Appliance

EXPERIMENTAL

Carriere Self-Ligating Bracket, Carlsbad, CA

Device: Appliance

Conventional bracket appliance

EXPERIMENTAL

Preadjusted edge wise brackets using elastomeric ties.

Device: Appliance

Interventions

Appliance DEVICE

Orthodontic appliance to carry out orthodontic tooth movement.

Clear Aligner Appliance; Conventional bracket appliance; Self-ligating Appliance

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• physically healthy with no relevant allergies or medical problems;
• above 12 years of age at commencement of treatment;
• in permanent dentition;
• less than 5 mm of anterior crowding or spacing with adequate overjet and overbite;
• ability to maintain adequate oral hygiene
• in optimum dental health without immediate need for any allied dental procedure.

You may not qualify if:

• skeletal anterior-posterior discrepancies between the maxilla and mandible (ANB ≥ 5°);
• centric relation - centric occlusion discrepancies of greater than 3 mm;
• presence of active periodontal disease.

Sponsors & Collaborators

• UConn Health: lead
• Align Technology, Inc.: collaborator

Study Sites (1)

Orthodontic Center at University of Connecticut Health Center

Farmington, Connecticut, 06032, United States

Location

Related Publications (1)

• Chhibber A, Agarwal S, Yadav S, Kuo CL, Upadhyay M. Which orthodontic appliance is best for oral hygiene? A randomized clinical trial. Am J Orthod Dentofacial Orthop. 2018 Feb;153(2):175-183. doi: 10.1016/j.ajodo.2017.10.009.

  PMID: 29407494 DERIVED

Limitations and Caveats

There was no protocol in place to monitor the compliance of the patient with clear aligners.

Results Point of Contact

• Title: Dr. Madhur Upadhyay, Director Orthodontic Clinic, Assistant Professor
• Organization: University of Connecticut Health

maupadhyay@uchc.edu

860-679-3729

Study Officials

• Madhur Upadhyay, BDS,MDS,MDSc

  UConn Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director (Orthodontic Clinic & Fellowship Program), Assistant Professor

Study Record Dates

• First Submitted: April 13, 2016
• First Posted: April 20, 2016
• Study Start: December 1, 2011
• Primary Completion: May 1, 2015
• Study Completion: November 1, 2015
• Last Updated: March 10, 2017
• Results First Posted: March 10, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)