Clinical trial NCT01286298: Diode Laser in Gingival Enlargement Related to Orthodontics
Official title: The Clinical Application of Diode Laser in Gingival Enlargement Related to Orthodontics
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gingival Overgrowth
Keywords: diode laser
gingival enlargement
gingival overgrowth
gingival hyperplasia
orthodontics
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2011-01-31
Enrollment: 20
Sex: ALL
Minimum age (years): 10
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Gingival Overgrowth Index
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Prince Philip Dental Hospital
Study officials:
affiliation: The University of Hong Kong
name: Tony NF TO, BDS, PDipGDS
role: PRINCIPAL_INVESTIGATOR
References: