NCT02352038

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 30, 2015

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

December 13, 2024

Status Verified

December 1, 2024

Enrollment Period

7.8 years

First QC Date

January 27, 2015

Last Update Submit

December 9, 2024

Conditions

Periodontal Disease

Keywords

malocclusionlow-level laser therapy

Outcome Measures

Primary Outcomes (1)

  • inflammatory cytokine levels in the gingival cervical fluid

    up to 12 months

Study Arms (2)

LLLT group

EXPERIMENTAL

LLLT group: orthodontic treatment and low-level laser therapy

Device: low-level laser therapyOther: orthodontic treatment

control group

PLACEBO COMPARATOR

Control group: orthodontic treatment and no laser treatment.

Other: orthodontic treatment

Interventions

low-level laser therapyDEVICE

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.

LLLT group
orthodontic treatmentOTHER

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.

LLLT groupcontrol group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Periodontal status confirmed by periodontal evaluation remains stable for at least 6 months after complete periodontal treatment.

You may not qualify if:

  • smoking;
  • pregnancy;
  • under orthodontic treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Prince Philip Dental Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Periodontal DiseasesMalocclusion

Interventions

Low-Level Light TherapyOrthodontics

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesTooth Diseases

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapyDentistry

Study Officials

  • Yanqi Yang

    The University of Hong Kong

    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
PRINCIPAL INVESTIGATOR
PI Title
Clinical assistant professor

Study Record Dates

First Submitted

January 27, 2015

First Posted

January 30, 2015

Study Start

April 1, 2014

Primary Completion

January 1, 2022

Study Completion

September 1, 2022

Last Updated

December 13, 2024

Record last verified: 2024-12

Locations

HK(1)