N/A
N=68
Comparison of Oral Hygiene & Root Resorption During Orthodontic Treatment
Orthodontic Pathological Resorption of External Root · Complication of Personal Oral Hygiene
Bottom Line
View on ClinicalTrials.gov: NCT02745626 ↗Enrolled (actual)
68
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcome: Primary: Plaque Index — 0.5; 0.7; 0.7; 0.8 Plaque Index (PI)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Appliance (Device)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- UConn Health
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Plaque Index |
0.5; 0.7; 0.7; 0.8; 1.4; 1.3 | — |
| SECONDARY Gingival Index |
0.4; 0.1; 0.1; 0.5; 1; 1.2 | — |
| SECONDARY Bleeding Index |
0.5; 0.6; 0.6; 0.6; 1.4; 1.3 | — |
| SECONDARY Total Bacterial Count |
7.9; 4.7; 4.4; 6; 32.7; 10.9 | — |
| SECONDARY S.Mutans Count |
0.8; 1; 1.1; 0.5; 0.8; 1.6 | — |
| SECONDARY Amount of Root Resorption Observed for Maxillary Lateral Incisor = Length of Root at T0-Length of Root at T2 (in mm) |
0.3; 0.9; 0.8 | — |
| SECONDARY Amount of Root Resorption Observed for Maxillary Second Premolar = Length of Root at T0-Length of Root at T2 (in mm) |
0.17; 0.16; 0.21 | — |
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
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02745626). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.