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CompletedNCT02441127

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
52 (actual)
Sponsor
Cukurova University · Academic / Other
Sex
All
Age
21 Years – 38 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DEVICEdiode laser groupthe 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.
PROCEDUREscalpel control groupIn 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

Timeline

Start date
2012-10-01
Primary completion
2014-04-01
Completion
2014-11-01
First posted
2015-05-12
Last updated
2015-05-13

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT02441127. Inclusion in this directory is not an endorsement.

Diode Laser for Harvesting Gingival Graft (NCT02441127) · Clinical Trials Directory