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

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.

Study Overview

• Status: Completed
• Conditions: Periodontal Disease
• Intervention / Treatment: Device: low-level laser therapy; Other: orthodontic treatment

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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LLLT group; LLLT group: orthodontic treatment and low-level laser therapy	Device: low-level laser therapy; 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.; Other: orthodontic treatment; 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.
Placebo Comparator: control group; Control group: orthodontic treatment and no laser treatment.	Other: orthodontic treatment; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
inflammatory cytokine levels in the gingival cervical fluid	up to 12 months

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Investigators: Principal Investigator: Yanqi Yang, The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2014
• Primary Completion (Actual): January 1, 2022
• Study Completion (Actual): September 1, 2022

Study Registration Dates

• First Submitted: January 27, 2015
• First Submitted That Met QC Criteria: January 29, 2015
• First Posted (Estimated): January 30, 2015

Study Record Updates

• Last Update Posted (Actual): December 13, 2024
• Last Update Submitted That Met QC Criteria: December 9, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: low-level laser therapy; malocclusion
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Periodontal Diseases
• Other Study ID Numbers: HMRF01121056

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The sharing of individual participant data has not been decided yet.