- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02441127
Diode Laser for Harvesting Gingival Graft
Diode Laser For Harvesting Subepithelial Connective Tissue Graft in The Treatment of Gingival Recession Defects: A Novel Approach to Limit Morbidity
Aims: The aim of present randomized controlled clinical study was to evaluate whether the additional use of diode laser would facilitate the donor surgery, improve the palatal wound healing and reduce post-operative morbidity after the coronally advanced flap (CAF) with connective tissue (CTG) grafts.
Methods: Fifty-two patients with isolated recessions were treated. The CTG resulted from the de-epithelialization of a free gingival graft (FGG) with blade (control group) or diode laser (DL) (test group). The DL was used to de-epithelialize the outer part of the FGG and photo-biostimulate the palatal wound area. Post-operative morbidity was evaluated by using Oral health related Quality of life (QoL), smile related QoL and visual analogue scale-discomfort (VAS). Root coverage outcomes were also evaluated 6 months after operation.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The procedure of connective tissue harvesting from the palate is often characterized by the challenge of obtaining the largest volume of tissue possible on one side while minimizing post-operative pain and reducing the risk of complications on the other.The present clinical study evaluated whether the additional use of diode laser would facilitate the donor surgery, improve the palatal wound healing and reduce post-operative morbidity after the bilaminar periodontal plastic surgery procedure for the treatment of isolated single gingival recession defects with no loss of interdental clinical attachment.
In the test sites, an aluminum, gallium, and arsenide diode laser (wavelength 810 nm and power of 1W) was applied in continuous mode. In the control group,a free (epithelialized) gingival graft was harvested by two horizontal and two vertical incisions defining the area. The post operative course of the patients were evaluated by visual analogical scale and the oral health impact profile
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Adana, Turkey, 01330
- Cukurova University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Presence of identifiable buccal cemento-enamel junction;
- Presence of a step ≤ 1mm at the cemento-enamel junction level
- No contraindications for periodontal surgery and no periodontal surgery on the involved sites
- Full-mouth plaque score of <10%; full-mouth bleeding score of <15%
- No occlusal interferences.
Exclusion Criteria:
- History of periodontitis or abscess formation
- Presence of systemic disease
- Smokers
- Pregnant patients.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Diode laser group
In the test sites, an aluminum, gallium, and arsenide diode laser (wavelength 810 nm and power of 1W) was applied in continuous mode.
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the laser tip was used to remove all visible epithelium in the outer side of the defined graft area.
The treatment was performed from the coronal to the apical aspect in parallel paths, and care was taken to avoid any laser contact to the palatal bone and periosteum by aiming the laser beam at a 450 angle to the palatal soft-tissue.
The resultant layer on the surface was totally removed with knife and moist gauze.
Then, the graft was harvested from the de-epithelized area with a 15c blade.
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Active Comparator: Scalpel control group
The surgical technique used in the control group was a FGG harvested by two horizontal and two vertical incisions by scalpel defining the area to be harvested .
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In the control group tissue was obtained by two horizontal and two vertical incisions defining the area to be harvested.
The blade was oriented perpendicular to the bone along the coronal horizontal incision and once an adequate soft tissue thickness was obtained; it was rotated in order to be parallel to the superficial surface.
The thickness of the graft was maintained uniform while proceeding apically with the blade until the FGG was harvested.
The palatal wound was protected with equine-derived collagen maintained by compressive sling 5-0 sutures
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Oral health related quality of life
Time Frame: 6 months
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6 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Complete root coverage
Time Frame: 6 months
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6 months
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Smile related quality of life
Time Frame: 6 months
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6 months
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Post-operative Discomfort on the Visual Analog scale
Time Frame: 1 month
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1 month
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Onur Ozcelik, PhD, Cukurova University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CukurovaU4
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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