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Diode Laser in Gingival Enlargement Related to Orthodontics

Primary Purpose

Gingival Overgrowth

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Laser gingivectomy
Laser gingivectomy
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Overgrowth focused on measuring diode laser, gingival enlargement, gingival overgrowth, gingival hyperplasia, orthodontics

Eligibility Criteria

10 Years - 40 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Prince Philip Dental HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Laser gingivectomy

Arm Description

Outcomes

Primary Outcome Measures

Gingival Overgrowth Index

Secondary Outcome Measures

Full Information

First Posted
January 27, 2011
Last Updated
January 27, 2011
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT01286298
Brief Title
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

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Unknown status
Study Start Date
October 2010 (undefined)
Primary Completion Date
April 2012 (Anticipated)
Study Completion Date
June 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
The University of Hong Kong

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Overgrowth
Keywords
diode laser, gingival enlargement, gingival overgrowth, gingival hyperplasia, orthodontics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Laser gingivectomy
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Laser gingivectomy
Other Intervention Name(s)
Biolase
Intervention Description
Gingivectomy by diode laser
Intervention Type
Procedure
Intervention Name(s)
Laser gingivectomy
Other Intervention Name(s)
Biolase
Intervention Description
Diode laser gingivectomy for gingival enlargement
Primary Outcome Measure Information:
Title
Gingival Overgrowth Index
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: between 10-40 year-olds (inclusive). gingival enlargement on the labial side of anterior teeth. fit and healthy. non-smokers. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tony To, BDS
Phone
852-94368232
Email
tonynfto@netvigator.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tony NF TO, BDS, PDipGDS
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince Philip Dental Hospital
City
Hong Kong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tony To, BDS
Phone
852-94368232
Email
tonynfto@netvigator.com
First Name & Middle Initial & Last Name & Degree
Tony To, BDS

12. IPD Sharing Statement

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Diode Laser in Gingival Enlargement Related to Orthodontics

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