Diode Laser for Harvesting Gingival Graft

NCT ID: NCT02441127

Last Updated: 2015-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2014-11-30

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

Conditions

Gingival Recession

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

diode laser group

Intervention Type: DEVICE

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.

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 .

Group Type: ACTIVE_COMPARATOR

scalpel control group

Intervention Type: PROCEDURE

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

Interventions

diode laser group

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.

Intervention Type: DEVICE

scalpel control group

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

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 38 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cukurova University

OTHER

Sponsor Role: lead

Responsible Party

Onur Ozcelik

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Onur Ozcelik, PhD

Role: PRINCIPAL_INVESTIGATOR

Cukurova University

Locations

Cukurova University

Adana, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

CukurovaU4

Identifier Type: -

Identifier Source: org_study_id