Diode Laser in Gingival Enlargement Related to Orthodontics

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by The University of Hong Kong.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01286298
First received: January 27, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted

January 27, 2011
January 27, 2011
October 2010
April 2012   (final data collection date for primary outcome measure)
Gingival Overgrowth Index [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Diode Laser in Gingival Enlargement Related to Orthodontics
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.

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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Gingival Overgrowth
  • Procedure: Laser gingivectomy
    Gingivectomy by diode laser
    Other Name: Biolase
  • Procedure: Laser gingivectomy
    Diode laser gingivectomy for gingival enlargement
    Other Name: Biolase
Experimental: Laser gingivectomy
Interventions:
  • Procedure: Laser gingivectomy
  • Procedure: Laser gingivectomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
June 2012
April 2012   (final data collection date for primary outcome measure)

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.
Both
10 Years to 40 Years
Yes
Contact: Tony To, BDS 852-94368232 tonynfto@netvigator.com
China
 
NCT01286298
UW 10-396
Yes
Dr. Tony Ngan-fat TO/ Master student, Orthodontics, Faculty of Dentistry, the University of Hong Kong
The University of Hong Kong
Not Provided
Principal Investigator: Tony NF TO, BDS, PDipGDS The University of Hong Kong
The University of Hong Kong
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP