Diode Laser in Gingival Enlargement Related to Orthodontics

January 27, 2011 updated by: The University of Hong Kong

The Clinical Application of Diode Laser in Gingival Enlargement Related to Orthodontics

Gingival enlargement is one of the most common soft tissue problems associated with fixed orthodontic treatment. The presence of orthodontic appliances impedes oral hygiene measures and alters the oral microbial ecosystem to a more pathogenic oral biofilm. Subsequent accumulation of plaque can contribute to development of chronic periodontal inflammation and can progress to gingival enlargement. Gingival enlargement inhibits hygiene measures, slows down orthodontic tooth movement and cause aesthetic and functional problems. Management of gingival enlargement by non-surgical periodontal treatment is considered to be most important and effective. Optimal plaque control can be maintained by meticulous brushing, flossing and professional scaling. However, motivation of maintaining oral hygiene can be disappointing in some patients. In cases that the enlarged gingivae became fibrous, surgical treatment can be considered.

Traditionally, gingivectomy was performed using scalpel under local infiltration. Since the first laser designed for dental use was introduced in 1989. Laser technology has continuously developed over the years and there are now many different types of dental lasers using a variety of wavelengths, e.g. Diode, Er:YAG, CO2 and Er,Cr:YSGG lasers. In orthodontics, various intraoral soft tissues surgical procedures may be required frequently, e.g. gingivectomy, gingivoplasty, fraenectomy, exposure of unerupted/ impacted/ partially erupted teeth. The use of laser has becoming more popular because the advantages of laser therapy are good haemostasis, excellent visualization of the operating field, fewer intra- and post-operative complications, bactericidal effect, no suture required, less scars, and better pain control with effects of reduced use of local anaesthesia and analgesic. Diode laser unit has the merits of compact size and relatively low price. Gingivectomy by diode laser may become an effective adjunctive treatment in orthodontic practice.

The aim of this study was to evaluate the clinical effectiveness of diode laser in the management of gingival enlargement related to orthodontic treatment.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The null hypothesis: diode laser gingivectomy is not effective in gingival enlargement related to orthodontic treatment.

Outcome measures:

Plaque Index Gingival Index Bleeding on Probing Probing Pocket Depth Gingival Overgrowth Index Pain score by VAS

Inclusion criteria:

  1. between 10-40 year-olds (inclusive).
  2. gingival enlargement on the labial side of anterior teeth.
  3. fit and healthy.
  4. non-smokers.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hong Kong, China
        • Recruiting
        • Prince Philip Dental Hospital
        • Contact:
        • Principal Investigator:
          • Tony To, BDS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 38 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. between 10-40 year-olds (inclusive).
  2. gingival enlargement on the labial side of anterior teeth.
  3. fit and healthy.
  4. non-smokers.

Exclusion Criteria:

  1. gingival enlargement resolved after non-surgical periodontal treatment.
  2. patients who refuse diode laser gingivectomy operation.
  3. smokers
  4. patients who are taking medications that may cause drug-associated gingival enlargement, e.g. calcium channel blockers, anticonvulsants or immunosuppressants.
  5. patients with lingual orthodontic appliance.
  6. pregnant or lactating women.
  7. patients who are not competent in giving consents.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Laser gingivectomy
Procedure: Laser gingivectomy
Gingivectomy by diode laser
Other Names:
  • Biolase
Procedure: Laser gingivectomy
Diode laser gingivectomy for gingival enlargement
Other Names:
  • Biolase

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Gingival Overgrowth Index
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Investigators

  • Principal Investigator: Tony NF TO, BDS, PDipGDS, The University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Anticipated)

April 1, 2012

Study Completion (Anticipated)

June 1, 2012

Study Registration Dates

First Submitted

January 27, 2011

First Submitted That Met QC Criteria

January 27, 2011

First Posted (Estimate)

January 31, 2011

Study Record Updates

Last Update Posted (Estimate)

January 31, 2011

Last Update Submitted That Met QC Criteria

January 27, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UW 10-396

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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