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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

Tracking Information
First Submitted Date  ICMJE January 27, 2015
First Posted Date  ICMJE January 30, 2015
Last Update Posted Date May 13, 2016
Study Start Date  ICMJE April 2014
Estimated Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2015)
inflammatory cytokine levels in the gingival cervical fluid [ Time Frame: up to 12 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 29, 2015)
inflammatory cytokine levels in the gingival crevical fluid [ Time Frame: up to 12 months ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized Controlled Trial of a Novel Laser-aided Orthodontic-periodontal Treatment Strategy
Official Title  ICMJE Randomized Controlled Trial of a Novel Laser-aided Orthodontic-periodontal Treatment Strategy
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Periodontal Disease
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: LLLT group
    LLLT group: orthodontic treatment and low-level laser therapy
    Interventions:
    • Device: low-level laser therapy
    • Other: orthodontic treatment
  • Placebo Comparator: control group
    Control group: orthodontic treatment and no laser treatment.
    Intervention: Other: orthodontic treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 29, 2015)
35
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2017
Estimated Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02352038
Other Study ID Numbers  ICMJE HMRF01121056
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: The sharing of individual participant data has not been decided yet.
Responsible Party Dr. Yanqi Yang, The University of Hong Kong
Study Sponsor  ICMJE The University of Hong Kong
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yanqi Yang The University of Hong Kong
PRS Account The University of Hong Kong
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP