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Completed

NCT Number: NCT02352038

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Prince Philip Dental Hospital

Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

  • smoking;
  • pregnancy;
  • under orthodontic treatment.

Treatment and study plan

Low-Level Laser Therapy

Device

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.

Orthodontic treatment

Other

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.

Primary outcomes

  1. inflammatory cytokine levels in the gingival cervical fluid

    Time frame: up to 12 months

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Important dates

Study start
2014
Primary completion
2022
Study completion
2022
First posted
Jan 30, 2015
Registry last updated
Dec 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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