search
Back to results

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

Primary Purpose

Periodontal Disease

Status
Unknown status
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
low-level laser therapy
orthodontic treatment
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontal Disease focused on measuring malocclusion, low-level laser therapy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • The Prince Philip Dental HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

LLLT group

control group

Arm Description

LLLT group: orthodontic treatment and low-level laser therapy

Control group: orthodontic treatment and no laser treatment.

Outcomes

Primary Outcome Measures

inflammatory cytokine levels in the gingival cervical fluid

Secondary Outcome Measures

Full Information

First Posted
January 27, 2015
Last Updated
May 12, 2016
Sponsor
The University of Hong Kong
search

1. Study Identification

Unique Protocol Identification Number
NCT02352038
Brief Title
Randomized Controlled Trial of a Novel Laser-aided Orthodontic-periodontal Treatment Strategy
Official Title
Randomized Controlled Trial of a Novel Laser-aided Orthodontic-periodontal Treatment Strategy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2014 (undefined)
Primary Completion Date
August 2017 (Anticipated)
Study Completion Date
August 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Disease
Keywords
malocclusion, low-level laser therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LLLT group
Arm Type
Experimental
Arm Description
LLLT group: orthodontic treatment and low-level laser therapy
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
Control group: orthodontic treatment and no laser treatment.
Intervention Type
Device
Intervention Name(s)
low-level laser therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
orthodontic treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
inflammatory cytokine levels in the gingival cervical fluid
Time Frame
up to 12 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Systemically health (with special regard to disease affecting tissue repair); No medications required for periodontal therapy and no use of any antibiotic and/or anti-inflammatory medication in the preceding month; 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. Periodontal status confirmed by periodontal evaluation remains stable for at least 6 months after complete periodontal treatment. Exclusion Criteria: smoking; pregnancy; under orthodontic treatment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yanqi Yang
Phone
+852-28590252
Email
yangyanq@hku.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanqi Yang
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Prince Philip Dental Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanqi Yang
Phone
+852-28590252
Email
yangyanq@hku.hk

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
The sharing of individual participant data has not been decided yet.

Learn more about this trial

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

We'll reach out to this number within 24 hrs