Periodontal Diseases Clinical Trial
Official title:
The Effectiveness of Low-level Laser Therapy as an Adjunct Strategy in Orthodontic Retention for Periodontal-compromised Patients
Verified date | April 2021 |
Source | The University of Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 35 |
Est. completion date | December 1, 2020 |
Est. primary completion date | June 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 25 Years to 65 Years |
Eligibility | 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. Exclusion Criteria: 1. smoking; 2. pregnancy; 3. under orthodontic treatment. |
Country | Name | City | State |
---|---|---|---|
Hong Kong | The Prince Philip Dental Hospital | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
The University of Hong Kong |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in probing pocket depth (PPD) | Record the changes of probing pocket depth in millimeters from baseline to 3 months, 6 months and 12 months through probing. | debond, 3 month follow-up, 6 month follow-up and 12 month follow-up | |
Primary | Changes in bleeding on probing (BOP) | Record the bleeding on probing changes from baseline to 3 months, 6 months and 12 months through probing. | debond, 3 month follow-up, 6 month follow-up and 12 month follow-up | |
Primary | Changes in clinical attachment loss (CAL) | Record the clinical attachment loss (CAL) changes from baseline to to 3 months, 6 months and 12 months. | debond, 3 month follow-up, 6 month follow-up and 12 month follow-up | |
Primary | Changes in plaque index (PI) | Record the plaque index (PI) changes from baseline to to 3 months, 6 months and 12 months. | debond, 3 month follow-up, 6 month follow-up and 12 month follow-up | |
Secondary | Orthodontic outcome stability | 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 | debond, 3 month follow-up, 6 month follow-up and 12 month follow-up | |
Secondary | Alveolar bone remodelling | 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. | debond, 12 month follow-up | |
Secondary | Supragingival and subgingival plaque | Bacteria loads in supragingival and subgingival plaques will be recorded. | debond, 1 month follow-up, 3 month follow-up, 6 month follow-up and 12 month follow-up | |
Secondary | Cervical dentin sensitivity | 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. | debond, each week interval during the first months, 3 months, 6 months and 12 months | |
Secondary | Maximum voluntary bite force | Use an standardized occlusal force gauge to record the magnitude of bite force in newton (N). | debond, 1 month follow-up, 3 month follow-up, 6 month follow-up and 12 month follow-up |
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