OrthodonticsNCT03765151
The Effectiveness of Low-level Laser Therapy in Orthodontic Retention for Periodontal-compromised Patients
A study testing low-level laser therapy and orthodontic retention in people with Orthodontics and Periodontal Diseases, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Orthodontics, Periodontal Diseases
- What is being tested?
- low-level laser therapy and orthodontic retention
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Oct 2018to 1 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- smoking;
- pregnancy;
- under orthodontic treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Orthodontics, Periodontal Diseases
- Being tested
- low-level laser therapy, orthodontic retention
- Keywords
- low-level laser therapy, orthodontic retention, periodontal disease
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low-level laser therapyDevice
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.
orthodontic retentionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| LLLT group | Experimental | Low-level laser therapy and orthodontic retention Receives: Device: low-level laser therapy; Other: orthodontic retention |
| control group | Placebo comparator | orthodontic retention and no laser treatment. Receives: Other: orthodontic retention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: debond, 3 month follow-up, 6 month follow-up and 12 month follow-up
Changes in bleeding on probing (BOP)
Record the bleeding on probing changes from baseline to 3 months, 6 months and 12 months through probing.
Measured: debond, 3 month follow-up, 6 month follow-up and 12 month follow-up
Changes in clinical attachment loss (CAL)
Record the clinical attachment loss (CAL) changes from baseline to to 3 months, 6 months and 12 months.
Measured: debond, 3 month follow-up, 6 month follow-up and 12 month follow-up
Changes in plaque index (PI)
Record the plaque index (PI) changes from baseline to to 3 months, 6 months and 12 months.
Measured: debond, 3 month follow-up, 6 month follow-up and 12 month follow-up
Secondary outcomes (5)
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
Measured: debond, 3 month follow-up, 6 month follow-up and 12 month follow-up
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.
Measured: debond, 12 month follow-up
Supragingival and subgingival plaque
Bacteria loads in supragingival and subgingival plaques will be recorded.
Measured: debond, 1 month follow-up, 3 month follow-up, 6 month follow-up and 12 month follow-up
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.
Measured: debond, each week interval during the first months, 3 months, 6 months and 12 months
Maximum voluntary bite force
Use an standardized occlusal force gauge to record the magnitude of bite force in newton (N).
Measured: debond, 1 month follow-up, 3 month follow-up, 6 month follow-up and 12 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study start1 Oct 2018
- Primary completion1 Jun 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OrthodonticsStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yanqi Yang, Principal investigator, The Prince Philip Dental Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03765151
- Sponsor's protocol ID
- HKUCTR-2390
- Status last verified
- Apr 2021
- First submitted
- 21 Nov 2018
- Last updated
- 29 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Low-level Laser Therapy as an Adjunct Strategy in Orthodontic Retention for Periodontal-compromised Patients
- ClinicalTrials.gov ID
- NCT03765151
- Acronym / sponsor ID
- HKUCTR-2390
- Conditions
- Orthodontics, Periodontal Diseases
- Keywords
- low-level laser therapy, orthodontic retention, periodontal disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 5 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LLLT group | Experimental | Device: low-level laser therapy, Other: orthodontic retentionLow-level laser therapy and orthodontic retention |
| control group | Placebo comparator | Other: orthodontic retentionorthodontic retention and no laser treatment. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- smoking;
- pregnancy;
- under orthodontic treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low-level laser therapyLLLT 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. | Device | LLLT group |
| orthodontic retentionAll 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. | Other | LLLT group, control group |
Primary outcome
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.
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.
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.
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.
5 secondary outcomes
Orthodontic outcome stability
Time frame: debond, 3 month follow-up, 6 month follow-up and 12 month follow-up
Alveolar bone remodelling
Time frame: 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
Cervical dentin sensitivity
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yanqi Yang principal investigator
The Prince Philip Dental Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low-level laser therapy and orthodontic retention in people with Orthodontics and Periodontal Diseases, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in probing pocket depth (PPD) (time frame: debond, 3 month follow-up, 6 month follow-up and 12 month follow-up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2021.