The Effectiveness of Low-level Laser Therapy in Orthodontic Retention for Periodontal-compromised Patients

Not Applicable

Completed

• Conditions: Periodontal Diseases; Orthodontics
• Interventions: Other: orthodontic retention; Device: low-level laser therapy

• Registration Number: NCT03765151
• Lead Sponsor: The University of Hong Kong

Brief Summary

The aim of the study is to evaluate the effects of low-level laser therapy (LLLT) on patients with chronic periodontitis during a post-orthodontic period for 12 months. Following aspects will be assessed: 1. Effects on tooth stability maintenance and bone remodeling. 2. Effects on periodontal inflammation status. 3. Effects on cervical dentin sensitivity and quality of life. The study design is a randomised controlled trail. To eliminate any bias, the investigator will initially hypothesis there is no significant difference in the aforementioned aspects between teeth retained with an adjunctive LLLT strategy and those retained in a conventional regimen.

Detailed Description

The study design is a randomised split-mouth design based on the result of investigator's pilot study. Thirty-five non-smoking Ethnic Chinese patients (male and female, age: 25-65 years) with chronic periodontitis will be recruited. The teeth in experimental group will receive LLLT during orthodontic retention period for 12 months, while the teeth in the control (placebo) group will not receive laser therapy. Orthodontic occlusal indices will be measured to explore LLLT's role in maintaining tooth stability. The effects of LLLT on periodontal inflammation status will be evaluated by assessing clinical periodontal parameters and the levels of supra-gingival and sub-gingival bacteria. The effects of LLLT on bone remodelling will be explored by testing the biochemical biomarkers in gingival crevicular fluid (GCF). Cone-beam computed tomography will also be used to provide clinical evidence of periodontal status and bone remodelling. Possible effects of LLLT on patient's quality of life will be investigated via validated questionnaires, subjective assessment of tooth sensitivity, and objective measurement of bite force.

Study Timeline

• Study Start: 2018-10-01
• Study First Submitted: 2018-11-21
• Study First Submitted QC: 2018-12-03
• Study First Posted: 2018-12-05
• Primary Completion: 2020-06-01
• Study Completion: 2020-12-01
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-27
• Last Update Posted: 2021-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Thirty-five non-smoking Ethnic Chinese patients (male or female; age: 25-65 years) will be recruited from the Prince Philip Dental Hospital, Faculty of Dentistry, the University of Hong Kong into the following selection criteria:

1. Systemically health (with special regard to disease affecting tissue repair);
2. No medications required for periodontal therapy and no use of any antibiotic and/or anti-inflammatory medication in the preceding month;
3. Chronic periodontitis with at least two pairs (clinically matched) displaced single-rooted teeth (each pair of teeth is in the same arch but in two contralateral hemi-arches respectively belonging to the same tooth typology) having at least one site probing depth of 5 mm or more, interproximal attachment loss of 3 mm or more, and radiographic signs of alveolar bone loss before periodontal and orthodontic treatment.
4. Recent completion of orthodontic treatment and readiness for debonding and retainer delivery.

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Exclusion Criteria

1. smoking;
2. pregnancy;
3. under orthodontic treatment.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
control group	orthodontic retention	orthodontic retention and no laser treatment.
LLLT group	low-level laser therapy	Low-level laser therapy and orthodontic retention
LLLT group	orthodontic retention	Low-level laser therapy and orthodontic retention

Primary Outcome Measures

Name	Time	Method
Changes in probing pocket depth (PPD)	debond, 3 month follow-up, 6 month follow-up and 12 month follow-up	Record the changes of probing pocket depth in millimeters from baseline to 3 months, 6 months and 12 months through probing.
Changes in bleeding on probing (BOP)	debond, 3 month follow-up, 6 month follow-up and 12 month follow-up	Record the bleeding on probing changes from baseline to 3 months, 6 months and 12 months through probing.
Changes in clinical attachment loss (CAL)	debond, 3 month follow-up, 6 month follow-up and 12 month follow-up	Record the clinical attachment loss (CAL) changes from baseline to to 3 months, 6 months and 12 months.
Changes in plaque index (PI)	debond, 3 month follow-up, 6 month follow-up and 12 month follow-up	Record the plaque index (PI) changes from baseline to to 3 months, 6 months and 12 months.

Secondary Outcome Measures

Name	Time	Method
Supragingival and subgingival plaque	debond, 1 month follow-up, 3 month follow-up, 6 month follow-up and 12 month follow-up	Bacteria loads in supragingival and subgingival plaques will be recorded.
Cervical dentin sensitivity	debond, each week interval during the first months, 3 months, 6 months and 12 months	Cervical dentin hypersensitivity will be evaluated by subjective assessment on a visual analogue scale (range from 0 to 100 mm) after a standardized stimuli applied on the test and control teeth.
Maximum voluntary bite force	debond, 1 month follow-up, 3 month follow-up, 6 month follow-up and 12 month follow-up	Use an standardized occlusal force gauge to record the magnitude of bite force in newton (N).
Orthodontic outcome stability	debond, 3 month follow-up, 6 month follow-up and 12 month follow-up	Assess the changes in Little's irregularity index (LII) in maxillar and mandibular anterior teeth in millimeters by measuring both plaster models and e-models
Alveolar bone remodelling	debond, 12 month follow-up	Alveolar bone remodelling will be assessed by the changes in height (measured in millimeters) and thickness (measured in millimeters) of alveolar marginal bone surrounding predetermined target teeth according to Cone Beam computed tomography.

Trial Locations

Locations (1)

The Prince Philip Dental Hospital; 🇭🇰 Hong Kong, Hong Kong