Diode Laser in Gingival Enlargement Related to Orthodontics

NCT ID: NCT01286298

Last Updated: 2011-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2012-06-30

Brief Summary

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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

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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.

Conditions

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Gingival Overgrowth

Keywords

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diode laser gingival enlargement gingival overgrowth gingival hyperplasia orthodontics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Laser gingivectomy

Group Type EXPERIMENTAL

Laser gingivectomy

Intervention Type PROCEDURE

Gingivectomy by diode laser

Laser gingivectomy

Intervention Type PROCEDURE

Diode laser gingivectomy for gingival enlargement

Interventions

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Laser gingivectomy

Gingivectomy by diode laser

Intervention Type PROCEDURE

Laser gingivectomy

Diode laser gingivectomy for gingival enlargement

Intervention Type PROCEDURE

Other Intervention Names

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Biolase Biolase

Eligibility Criteria

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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.
Minimum Eligible Age

10 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Orthodontics, Faculty of Dentistry, the University of Hong Kong

Principal Investigators

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Tony NF TO, BDS, PDipGDS

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

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Prince Philip Dental Hospital

Hong Kong, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Tony To, BDS

Role: CONTACT

Phone: 852-94368232

Email: [email protected]

Facility Contacts

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Tony To, BDS

Role: primary

Other Identifiers

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UW 10-396

Identifier Type: -

Identifier Source: org_study_id