Randomized Controlled Trial of a Novel Laser-aided Orthodontic-periodontal Treatment Strategy

Not Applicable

Completed

• Conditions: Periodontal Disease
• Interventions: Device: low-level laser therapy; Other: orthodontic treatment

• Registration Number: NCT02352038
• Lead Sponsor: The University of Hong Kong

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 Timeline

• Study Start: 2014-04
• Study First Submitted: 2015-01-27
• Study First Submitted QC: 2015-01-29
• Study First Posted: 2015-01-30
• Primary Completion: 2022-01
• Study Completion: 2022-09
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-13

Recruitment & Eligibility

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

Inclusion 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.
4. Periodontal status confirmed by periodontal evaluation remains stable for at least 6 months after complete periodontal treatment.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
inflammatory cytokine levels in the gingival cervical fluid	up to 12 months

Trial Locations

Locations (1)

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