Diode Laser in Gingival Enlargement Related to Orthodontics

NCT01286298 | Unknown DMC

• 1 other identifier: UW 10-396
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gingival Overgrowth

Keywords

diode laser; gingival enlargement; gingival overgrowth; gingival hyperplasia; orthodontics

Outcome Measures

Primary Outcomes (1)

• Gingival Overgrowth Index

  3 months

Study Arms (1)

Laser gingivectomy

EXPERIMENTAL

Procedure: Laser gingivectomy

Interventions

Laser gingivectomy PROCEDURE

Gingivectomy by diode laser

Also known as: Biolase

Laser gingivectomy

Eligibility Criteria

• Age: 10 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Prince Philip Dental Hospital

Hong Kong, China

RECRUITING

MeSH Terms

Conditions

Gingival Overgrowth; Gingival Hyperplasia

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Tony NF TO, BDS, PDipGDS

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tony To, BDS

CONTACT

852-94368232; tonynfto@netvigator.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 27, 2011
• First Posted: January 31, 2011
• Study Start: October 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: June 1, 2012
• Last Updated: January 31, 2011

Record last verified: 2011-01

Locations

CN (1)