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

The University of Hong Kong (HKU)

Status: Completed

Conditions: Periodontal Disease

Treatments: Other: orthodontic treatment; Device: low-level laser therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02352038

HMRF01121056

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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35 participants in 2 patient groups, including a placebo group

LLLT group

Experimental group

Description:

LLLT group: orthodontic treatment and low-level laser therapy

Treatment:

Device: low-level laser therapy

Other: orthodontic treatment

control group

Placebo Comparator group

Description:

Control group: orthodontic treatment and no laser treatment.

Treatment:

Other: orthodontic treatment