Trial record 12 of 26 for:    Open Studies | "Gingival Diseases"

Diode Laser in Gingival Enlargement Related to Orthodontics

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by The University of Hong Kong.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01286298
First received: January 27, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  Purpose

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.


Condition Intervention
Gingival Overgrowth
Procedure: Laser gingivectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Clinical Application of Diode Laser in Gingival Enlargement Related to Orthodontics

Resource links provided by NLM:


Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • Gingival Overgrowth Index [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: October 2010
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Laser gingivectomy Procedure: Laser gingivectomy
Gingivectomy by diode laser
Other Name: Biolase
Procedure: Laser gingivectomy
Diode laser gingivectomy for gingival enlargement
Other Name: Biolase

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

Ages Eligible for Study:   10 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01286298

Contacts
Contact: Tony To, BDS 852-94368232 tonynfto@netvigator.com

Locations
China
Prince Philip Dental Hospital Recruiting
Hong Kong, China
Contact: Tony To, BDS    852-94368232    tonynfto@netvigator.com   
Principal Investigator: Tony To, BDS         
Sponsors and Collaborators
The University of Hong Kong
Investigators
Principal Investigator: Tony NF TO, BDS, PDipGDS The University of Hong Kong
  More Information

No publications provided

Responsible Party: Dr. Tony Ngan-fat TO/ Master student, Orthodontics, Faculty of Dentistry, the University of Hong Kong
ClinicalTrials.gov Identifier: NCT01286298     History of Changes
Other Study ID Numbers: UW 10-396
Study First Received: January 27, 2011
Last Updated: January 27, 2011
Health Authority: Hong Kong: Department of Health

Keywords provided by The University of Hong Kong:
diode laser
gingival enlargement
gingival overgrowth
gingival hyperplasia
orthodontics

Additional relevant MeSH terms:
Gingival Hyperplasia
Gingival Overgrowth
Hypertrophy
Gingival Diseases
Mouth Diseases
Pathological Conditions, Anatomical
Periodontal Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on October 29, 2014