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The Effectiveness of Low-level Laser Therapy in Orthodontic Retention for Periodontal-compromised Patients

Primary Purpose

Orthodontics, Periodontal Diseases

Status

Completed

Phase

Not Applicable

Locations

Hong Kong

Study Type

Interventional

Intervention

low-level laser therapy

orthodontic retention

About this trial

This is an interventional treatment trial for Orthodontics focused on measuring low-level laser therapy, orthodontic retention, periodontal disease

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Thirty-five non-smoking Ethnic Chinese patients (male or female; age: 25-65 years) will be recruited from the Prince Philip Dental Hospital, Faculty of Dentistry, the University of Hong Kong into the following selection 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 before periodontal and orthodontic treatment.
Recent completion of orthodontic treatment and readiness for debonding and retainer delivery.

Exclusion Criteria:

smoking;
pregnancy;
under orthodontic treatment.

Sites / Locations

The Prince Philip Dental Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

LLLT group

control group

Arm Description

Low-level laser therapy and orthodontic retention

orthodontic retention and no laser treatment.

Outcomes

Primary Outcome Measures

Changes in probing pocket depth (PPD)

Record the changes of probing pocket depth in millimeters from baseline to 3 months, 6 months and 12 months through probing.

Changes in bleeding on probing (BOP)

Record the bleeding on probing changes from baseline to 3 months, 6 months and 12 months through probing.

Changes in clinical attachment loss (CAL)

Record the clinical attachment loss (CAL) changes from baseline to to 3 months, 6 months and 12 months.

Changes in plaque index (PI)

Record the plaque index (PI) changes from baseline to to 3 months, 6 months and 12 months.

Secondary Outcome Measures

Orthodontic outcome stability

Assess the changes in Little's irregularity index (LII) in maxillar and mandibular anterior teeth in millimeters by measuring both plaster models and e-models

Alveolar bone remodelling

Alveolar bone remodelling will be assessed by the changes in height (measured in millimeters) and thickness (measured in millimeters) of alveolar marginal bone surrounding predetermined target teeth according to Cone Beam computed tomography.

Supragingival and subgingival plaque

Bacteria loads in supragingival and subgingival plaques will be recorded.

Cervical dentin sensitivity

Cervical dentin hypersensitivity will be evaluated by subjective assessment on a visual analogue scale (range from 0 to 100 mm) after a standardized stimuli applied on the test and control teeth.

Maximum voluntary bite force

Use an standardized occlusal force gauge to record the magnitude of bite force in newton (N).

Full Information

NCT ID

NCT03765151

First Posted

November 21, 2018

Last Updated

April 27, 2021

Sponsor

The University of Hong Kong

1. Study Identification

Unique Protocol Identification Number

NCT03765151

Brief Title

The Effectiveness of Low-level Laser Therapy in Orthodontic Retention for Periodontal-compromised Patients

Official Title

The Effectiveness of Low-level Laser Therapy as an Adjunct Strategy in Orthodontic Retention for Periodontal-compromised Patients

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

October 1, 2018 (Actual)

Primary Completion Date

June 1, 2020 (Actual)

Study Completion Date

December 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

The aim of the study is to evaluate the effects of low-level laser therapy (LLLT) on patients with chronic periodontitis during a post-orthodontic period for 12 months. Following aspects will be assessed: 1. Effects on tooth stability maintenance and bone remodeling. 2. Effects on periodontal inflammation status. 3. Effects on cervical dentin sensitivity and quality of life. The study design is a randomised controlled trail. To eliminate any bias, the investigator will initially hypothesis there is no significant difference in the aforementioned aspects between teeth retained with an adjunctive LLLT strategy and those retained in a conventional regimen.

Detailed Description

The study design is a randomised split-mouth design based on the result of investigator's pilot study. Thirty-five non-smoking Ethnic Chinese patients (male and female, age: 25-65 years) with chronic periodontitis will be recruited. The teeth in experimental group will receive LLLT during orthodontic retention period for 12 months, while the teeth in the control (placebo) group will not receive laser therapy. Orthodontic occlusal indices will be measured to explore LLLT's role in maintaining tooth stability. The effects of LLLT on periodontal inflammation status will be evaluated by assessing clinical periodontal parameters and the levels of supra-gingival and sub-gingival bacteria. The effects of LLLT on bone remodelling will be explored by testing the biochemical biomarkers in gingival crevicular fluid (GCF). Cone-beam computed tomography will also be used to provide clinical evidence of periodontal status and bone remodelling. Possible effects of LLLT on patient's quality of life will be investigated via validated questionnaires, subjective assessment of tooth sensitivity, and objective measurement of bite force.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Orthodontics, Periodontal Diseases

Keywords

low-level laser therapy, orthodontic retention, periodontal disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

35 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LLLT group

Arm Type

Experimental

Arm Description

Low-level laser therapy and orthodontic retention

Arm Title

control group

Arm Type

Placebo Comparator

Arm Description

orthodontic retention and no laser treatment.

Intervention Type

Device

Intervention Name(s)

low-level laser therapy

Intervention Description

LLLT will be performed by a diode gallium-aluminum-arsenide (Ga-Al-As) laser with a 940-nm wavelength (Ezlase; Biolase Technology Inc., Irvine, CA) and delivered by a quadrant-sized probe which cover the region from the central incisor to the first molar on the test side. The laser probe will be 1 cm from the soft tissue around the test tooth at the gingival margin and alveolar mucosa covering the root area using a setting of 800 milliwatt in a continuous wave. Each tooth will receive 30 seconds of exposure, with no more than 8.6 J/cm2 of energy delivered. In addition, a spot-size laser probe will be applied for 30 seconds 5 mm from the cervical dentin with an output power of 700 milliwatt to reduce tooth sensitivity.

Intervention Type

Other

Intervention Name(s)

orthodontic retention

Intervention Description

All participants included will wear fixed lingual retainer and removable retainers in the post-orthodontic retention period and their previous orthodontic treatment will be carried out by one operator using preadjusted appliances with bonded 0.022×0.028-inch2 brackets/buccal tubes and 0.014-inch Nickel Titanium (NiTi) archwires as the first archwires.

Primary Outcome Measure Information:

Title

Changes in probing pocket depth (PPD)

Description

Record the changes of probing pocket depth in millimeters from baseline to 3 months, 6 months and 12 months through probing.

Time Frame

debond, 3 month follow-up, 6 month follow-up and 12 month follow-up

Title

Changes in bleeding on probing (BOP)

Description

Record the bleeding on probing changes from baseline to 3 months, 6 months and 12 months through probing.

Time Frame

debond, 3 month follow-up, 6 month follow-up and 12 month follow-up

Title

Changes in clinical attachment loss (CAL)

Description

Record the clinical attachment loss (CAL) changes from baseline to to 3 months, 6 months and 12 months.

Time Frame

debond, 3 month follow-up, 6 month follow-up and 12 month follow-up

Title

Changes in plaque index (PI)

Description

Record the plaque index (PI) changes from baseline to to 3 months, 6 months and 12 months.

Time Frame

debond, 3 month follow-up, 6 month follow-up and 12 month follow-up

Secondary Outcome Measure Information:

Title

Orthodontic outcome stability

Description

Assess the changes in Little's irregularity index (LII) in maxillar and mandibular anterior teeth in millimeters by measuring both plaster models and e-models

Time Frame

debond, 3 month follow-up, 6 month follow-up and 12 month follow-up

Title

Alveolar bone remodelling

Description

Time Frame

debond, 12 month follow-up

Title

Supragingival and subgingival plaque

Description

Bacteria loads in supragingival and subgingival plaques will be recorded.

Time Frame

debond, 1 month follow-up, 3 month follow-up, 6 month follow-up and 12 month follow-up

Title

Cervical dentin sensitivity

Description

Cervical dentin hypersensitivity will be evaluated by subjective assessment on a visual analogue scale (range from 0 to 100 mm) after a standardized stimuli applied on the test and control teeth.

Time Frame

debond, each week interval during the first months, 3 months, 6 months and 12 months

Title

Maximum voluntary bite force

Description

Use an standardized occlusal force gauge to record the magnitude of bite force in newton (N).

Time Frame

debond, 1 month follow-up, 3 month follow-up, 6 month follow-up and 12 month follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Thirty-five non-smoking Ethnic Chinese patients (male or female; age: 25-65 years) will be recruited from the Prince Philip Dental Hospital, Faculty of Dentistry, the University of Hong Kong into the following selection 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 before periodontal and orthodontic treatment. Recent completion of orthodontic treatment and readiness for debonding and retainer delivery. Exclusion Criteria: smoking; pregnancy; under orthodontic treatment.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yanqi Yang

Organizational Affiliation

The Prince Philip Dental Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Prince Philip Dental Hospital

City

Hong Kong

Country

Hong Kong

12. IPD Sharing Statement

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The Effectiveness of Low-level Laser Therapy in Orthodontic Retention for Periodontal-compromised Patients

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