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

April 27, 2021 updated by: The University of Hong Kong

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • The Prince Philip Dental Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

25 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

  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 before periodontal and orthodontic treatment.
  4. Recent completion of orthodontic treatment and readiness for debonding and retainer delivery.

Exclusion Criteria:

  1. smoking;
  2. pregnancy;
  3. under orthodontic treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: LLLT group
Low-level laser therapy and orthodontic retention
Device: low-level laser therapy
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.
Other: orthodontic retention
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.
Placebo Comparator: control group
orthodontic retention and no laser treatment.
Other: orthodontic retention
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in probing pocket depth (PPD)
Time Frame: debond, 3 month follow-up, 6 month follow-up and 12 month follow-up
Record the changes of probing pocket depth in millimeters from baseline to 3 months, 6 months and 12 months through probing.
debond, 3 month follow-up, 6 month follow-up and 12 month follow-up
Changes in bleeding on probing (BOP)
Time Frame: debond, 3 month follow-up, 6 month follow-up and 12 month follow-up
Record the bleeding on probing changes from baseline to 3 months, 6 months and 12 months through probing.
debond, 3 month follow-up, 6 month follow-up and 12 month follow-up
Changes in clinical attachment loss (CAL)
Time Frame: debond, 3 month follow-up, 6 month follow-up and 12 month follow-up
Record the clinical attachment loss (CAL) changes from baseline to to 3 months, 6 months and 12 months.
debond, 3 month follow-up, 6 month follow-up and 12 month follow-up
Changes in plaque index (PI)
Time Frame: debond, 3 month follow-up, 6 month follow-up and 12 month follow-up
Record the plaque index (PI) changes from baseline to to 3 months, 6 months and 12 months.
debond, 3 month follow-up, 6 month follow-up and 12 month follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Orthodontic outcome stability
Time Frame: debond, 3 month follow-up, 6 month follow-up and 12 month follow-up
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
debond, 3 month follow-up, 6 month follow-up and 12 month follow-up
Alveolar bone remodelling
Time Frame: debond, 12 month follow-up
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.
debond, 12 month follow-up
Supragingival and subgingival plaque
Time Frame: debond, 1 month follow-up, 3 month follow-up, 6 month follow-up and 12 month follow-up
Bacteria loads in supragingival and subgingival plaques will be recorded.
debond, 1 month follow-up, 3 month follow-up, 6 month follow-up and 12 month follow-up
Cervical dentin sensitivity
Time Frame: debond, each week interval during the first months, 3 months, 6 months and 12 months
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.
debond, each week interval during the first months, 3 months, 6 months and 12 months
Maximum voluntary bite force
Time Frame: debond, 1 month follow-up, 3 month follow-up, 6 month follow-up and 12 month follow-up
Use an standardized occlusal force gauge to record the magnitude of bite force in newton (N).
debond, 1 month follow-up, 3 month follow-up, 6 month follow-up and 12 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Hong Kong

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yanqi Yang, The Prince Philip Dental Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 21, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 5, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 29, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HKUCTR-2390

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Periodontal Diseases

Clinical Trials on low-level laser therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings