Clinical trial NCT02441127: Diode Laser for Harvesting Gingival Graft
Official title: Diode Laser For Harvesting Subepithelial Connective Tissue Graft in The Treatment of Gingival Recession Defects: A Novel Approach to Limit Morbidity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession
Keywords: free gingival graft
diode laser
donor site
mucogingival surgery
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2015-05-12
Enrollment: 52
Sex: ALL
Minimum age (years): 21
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Oral health related quality of life
timeFrame: 6 months
Secondary outcomes:
measure: Complete root coverage
timeFrame: 6 months
measure: Smile related quality of life
timeFrame: 6 months
measure: Post-operative Discomfort on the Visual Analog scale
timeFrame: 1 month
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Cukurova University
Study officials:
affiliation: Cukurova University
name: Onur Ozcelik, PhD
role: PRINCIPAL_INVESTIGATOR
References: