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

NCT03765151 | Completed

• 1 other identifier: HKUCTR-2390
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Orthodontics; Periodontal Diseases

Keywords

low-level laser therapy; orthodontic retention; periodontal disease

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

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

Secondary Outcomes (5)

• Orthodontic outcome stability

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

• Alveolar bone remodelling

  debond, 12 month follow-up

• Supragingival and subgingival plaque

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

• Cervical dentin sensitivity

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

• Maximum voluntary bite force

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

Study Arms (2)

LLLT group

EXPERIMENTAL

Low-level laser therapy and orthodontic retention

Device: low-level laser therapy; Other: orthodontic retention

control group

PLACEBO COMPARATOR

orthodontic retention and no laser treatment.

Other: orthodontic retention

Interventions

low-level laser therapy DEVICE

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.

LLLT group

orthodontic retention OTHER

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.

LLLT group; control group

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• smoking;
• pregnancy;
• under orthodontic treatment.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The Prince Philip Dental Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Periodontal Diseases

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Yanqi Yang

  The Prince Philip Dental Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2018
• First Posted: December 5, 2018
• Study Start: October 1, 2018
• Primary Completion: June 1, 2020
• Study Completion: December 1, 2020
• Last Updated: April 29, 2021

Record last verified: 2021-04

Locations

HK (1)