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Clinical Trials/NCT03765151
NCT03765151
Completed
Not Applicable

The Effectiveness of Low-level Laser Therapy as an Adjunct Strategy in Orthodontic Retention for Periodontal-compromised Patients

The University of Hong Kong1 site in 1 country35 target enrollmentOctober 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Orthodontics
Sponsor
The University of Hong Kong
Enrollment
35
Locations
1
Primary Endpoint
Changes in probing pocket depth (PPD)
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2018
End Date
December 1, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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:
  • Systemically health (with special regard to disease affecting tissue repair);
  • No medications required for periodontal therapy and no use of any antibiotic and/or anti-inflammatory medication in the preceding month;
  • 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.
  • Recent completion of orthodontic treatment and readiness for debonding and retainer delivery.

Exclusion Criteria

  • under orthodontic treatment.

Outcomes

Primary Outcomes

Changes in probing pocket depth (PPD)

Time Frame: 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)

Time Frame: 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)

Time Frame: 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)

Time Frame: 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 Outcomes

  • Supragingival and subgingival plaque(debond, 1 month follow-up, 3 month follow-up, 6 month follow-up and 12 month follow-up)
  • Cervical dentin sensitivity(debond, each week interval during the first months, 3 months, 6 months and 12 months)
  • Maximum voluntary bite force(debond, 1 month follow-up, 3 month follow-up, 6 month follow-up and 12 month follow-up)
  • Orthodontic outcome stability(debond, 3 month follow-up, 6 month follow-up and 12 month follow-up)
  • Alveolar bone remodelling(debond, 12 month follow-up)

Study Sites (1)

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