Gingival OvergrowthNCT01286298
Diode Laser in Gingival Enlargement Related to Orthodontics
A study testing Laser gingivectomy in people with Gingival Overgrowth, run by The University of Hong Kong at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 10 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Overgrowth
- What is being tested?
- Laser gingivectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Oct 2010to Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- between 10-40 year-olds (inclusive).
- gingival enlargement on the labial side of anterior teeth.
- fit and healthy.
- non-smokers.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Prince Philip Dental Hospital
Hong Kong
Tony To, BDS, 852-94368232, tonynfto@netvigator.com
Tony To, BDS
About this study
Official title: The Clinical Application of Diode Laser in Gingival Enlargement Related to Orthodontics
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.
Read the 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.
- Conditions
- Gingival Overgrowth
- Being tested
- Laser gingivectomy
- Keywords
- diode laser, gingival enlargement, gingival overgrowth, gingival hyperplasia, orthodontics
- Medical subject headings
- Gingival Overgrowth, Gingival Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser gingivectomyProcedure or surgery
Also called Biolase
Gingivectomy by diode laser
Laser gingivectomyProcedure or surgery
Also called Biolase
Diode laser gingivectomy for gingival enlargement
| Study group | Role | What they receive |
|---|---|---|
| Laser gingivectomy | Experimental | Not described Receives: Procedure: Laser gingivectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival Overgrowth Index
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2011 (estimated)
- Study startOct 2010
- Primary completionApr 2012 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival OvergrowthStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Investigators
- Tony NF TO, BDS, PDipGDS, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01286298
- Sponsor's protocol ID
- UW 10-396
- Status last verified
- Jan 2011
- First submitted
- 27 Jan 2011
- Last updated
- 31 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Application of Diode Laser in Gingival Enlargement Related to Orthodontics
- ClinicalTrials.gov ID
- NCT01286298
- Acronym / sponsor ID
- UW 10-396
- Conditions
- Gingival Overgrowth
- Keywords
- diode laser, gingival enlargement, gingival overgrowth, gingival hyperplasia, orthodontics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Apr 2012 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 31 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laser gingivectomy | Experimental | Procedure: Laser gingivectomy |
Who may qualify
- Ages
- 10 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- between 10-40 year-olds (inclusive).
- gingival enlargement on the labial side of anterior teeth.
- fit and healthy.
- non-smokers.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser gingivectomyAlso: BiolaseGingivectomy by diode laser | Procedure or surgery | Laser gingivectomy |
| Laser gingivectomyAlso: BiolaseDiode laser gingivectomy for gingival enlargement | Procedure or surgery | Laser gingivectomy |
Primary outcome
Gingival Overgrowth Index
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2011.
Related trials for Gingival Overgrowth
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Periodontal Plastic Reconstruction of Soft Tissue Dehiscences After the Removal of Localized Gingival Enlargements
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tony NF TO, BDS, PDipGDS principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser gingivectomy in people with Gingival Overgrowth, run by The University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tony To, BDS (852-94368232, tonynfto@netvigator.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gingival Overgrowth Index (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2011.