Diode Laser in Gingival Enlargement Related to Orthodontics

Gingival Overgrowth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01286298
• Other study ID #: UW 10-396
• Status: Recruiting
• Phase: N/A
• First received: January 27, 2011
• Last updated: January 27, 2011
• Start date: October 2010
• Est. completion date: June 2012

Study information

• Verified date: January 2011
• Source: The University of Hong Kong
• Contact: Tony To, BDS
• Phone: 852-94368232
• Email: tonynfto[@]netvigator.com
• Is FDA regulated: No
• Health authority: Hong Kong: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 10 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gingival Hyperplasia
• Gingival Overgrowth
• Hypertrophy

Intervention

Procedure:
• Laser gingivectomy
Gingivectomy by diode laser
• Laser gingivectomy
Diode laser gingivectomy for gingival enlargement

Locations

Country	Name	City	State
China	Prince Philip Dental Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gingival Overgrowth Index		3 months	No