Randomized Controlled Trial of a Novel Laser-aided Orthodontic-periodontal Treatment Strategy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- The University of Hong Kong
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- inflammatory cytokine levels in the gingival cervical fluid
Study Overview
Brief Summary
The aim of the study is to assess the effects of low-level laser therapy (LLLT) in patients with periodontitis during orthodontic-periodontal treatment for 12 months on the following aspects: (1) Effects on periodontal status; (2) Effects on alveolar bone remodeling; (3) Effects on cervical dentin sensitivity; (4) Effects on pain and quality of life.
To eliminate any bias, the investigators will initially hypothesize that there is no difference in periodontal status, jawbone remodeling, tooth sensitivity, pain and quality of life in patients having teeth with chronic periodontitis and receiving LLLT with orthodontic treatment versus teeth undergoing orthodontic treatment without incorporation of LLLT.
Detailed Description
On the basis of the investigators' pilot study results, 35 patients with chronic periodontitis will be recruited and initially treated for inflammation. Using a randomized split-mouth design,the teeth in experimental (laser) group will receive LLLT while the teeth in the control (placebo) group will receive no laser treatment. The effects of LLLT in orthodontic-periodontal treatment on periodontal inflammation control, jawbone remodeling, reduction of tooth sensitivity, pain relief and quality of life will be investigated.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion 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.
- •Periodontal status confirmed by periodontal evaluation remains stable for at least 6 months after complete periodontal treatment.
Exclusion Criteria
- •under orthodontic treatment.
Arms & Interventions
LLLT group
LLLT group: orthodontic treatment and low-level laser therapy
Intervention: low-level laser therapy (Device)
LLLT group
LLLT group: orthodontic treatment and low-level laser therapy
Intervention: orthodontic treatment (Other)
control group
Control group: orthodontic treatment and no laser treatment.
Intervention: orthodontic treatment (Other)
Outcomes
Primary Outcomes
inflammatory cytokine levels in the gingival cervical fluid
Time Frame: up to 12 months
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr. Yanqi Yang
Clinical assistant professor
The University of Hong Kong