Diode Laser for Harvesting Gingival Graft

Not Applicable

Completed

• Conditions: Gingival Recession
• Interventions: Device: diode laser group; Procedure: scalpel control group

• Registration Number: NCT02441127
• Lead Sponsor: Cukurova University

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

Study Timeline

• Study Start: 2012-10
• Primary Completion: 2014-04
• Study Completion: 2014-11
• Study First Submitted: 2015-04-29
• Status Verified: 2015-05
• Study First Submitted QC: 2015-05-07
• Study First Posted: 2015-05-12
• Last Update Submitted: 2015-05-12
• Last Update Posted: 2015-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diode laser group	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.
Scalpel control group	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 .

Primary Outcome Measures

Name	Time	Method
Oral health related quality of life	6 months

Secondary Outcome Measures

Name	Time	Method
Post-operative Discomfort on the Visual Analog scale	1 month
Smile related quality of life	6 months
Complete root coverage	6 months

Trial Locations

Locations (1)

Cukurova University; 🇹🇷 Adana, Turkey