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

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ClinicalTrials.gov Identifier: NCT02352038
Recruitment Status : Unknown
Verified May 2016 by Dr. Yanqi Yang, The University of Hong Kong.
Recruitment status was:  Recruiting
First Posted : January 30, 2015
Last Update Posted : May 13, 2016
Sponsor:
Information provided by (Responsible Party):
Dr. Yanqi Yang, The University of Hong Kong

Study Description
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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
Periodontal Disease Device: low-level laser therapy Other: orthodontic treatment Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 2014
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Orthodontia

Arms and Interventions
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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
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Primary Outcome Measures :
  1. inflammatory cytokine levels in the gingival cervical fluid [ Time Frame: up to 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02352038


Contacts
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Contact: Yanqi Yang +852-28590252 yangyanq@hku.hk

Locations
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Hong Kong
The Prince Philip Dental Hospital Recruiting
Hong Kong, Hong Kong
Contact: Yanqi Yang    +852-28590252    yangyanq@hku.hk   
Sponsors and Collaborators
The University of Hong Kong
Investigators
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Principal Investigator: Yanqi Yang The University of Hong Kong
More Information
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Responsible Party: Dr. Yanqi Yang, Clinical assistant professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT02352038    
Other Study ID Numbers: HMRF01121056
First Posted: January 30, 2015    Key Record Dates
Last Update Posted: May 13, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The sharing of individual participant data has not been decided yet.
Keywords provided by Dr. Yanqi Yang, The University of Hong Kong:
malocclusion
low-level laser therapy
Additional relevant MeSH terms:
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Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases