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

Sponsor
The University of Hong Kong (Other)
Overall Status
Unknown status
CT.gov ID
NCT02352038
Collaborator
(none)
35
1
2
40
0.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: low-level laser therapy
  • Other: orthodontic treatment
N/A

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
Anticipated Enrollment :
35 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Randomized Controlled Trial of a Novel Laser-aided Orthodontic-periodontal Treatment Strategy
Study Start Date :
Apr 1, 2014
Anticipated Primary Completion Date :
Aug 1, 2017
Anticipated Study Completion Date :
Aug 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: LLLT group

LLLT group: orthodontic treatment and low-level laser therapy

Device: low-level laser therapy
The test teeth will receive LLLT using a 940 nanometer diode laser (EZLASE; BIOLASE Technology Inc., Irvine, CA, USA) with output power of 330 milliwatt. The experimental side was irradiated for 30 s in two sessions, delivering an energy density of 7 Joules per square centimeter.

Other: orthodontic treatment
Orthodontic treatment will be carried out using preadjusted appliances with bonded 0.022×0.028-square inch brackets/buccal tubes and 0.014-inch NiTi archwires as the first archwires. The treatment or the major part of the treatment will be completed in 12 months.

Placebo Comparator: control group

Control group: orthodontic treatment and no laser treatment.

Other: orthodontic treatment
Orthodontic treatment will be carried out using preadjusted appliances with bonded 0.022×0.028-square inch brackets/buccal tubes and 0.014-inch NiTi archwires as the first archwires. The treatment or the major part of the treatment will be completed in 12 months.

Outcome Measures

Primary Outcome Measures

  1. inflammatory cytokine levels in the gingival cervical fluid [up to 12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Prince Philip Dental Hospital Hong Kong Hong Kong

Sponsors and Collaborators

  • The University of Hong Kong

Investigators

  • Principal Investigator: Yanqi Yang, The University of Hong Kong

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr. Yanqi Yang, Clinical assistant professor, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT02352038
Other Study ID Numbers:
  • HMRF01121056
First Posted:
Jan 30, 2015
Last Update Posted:
May 13, 2016
Last Verified:
May 1, 2016
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Keywords provided by Dr. Yanqi Yang, Clinical assistant professor, The University of Hong Kong
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 13, 2016