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Diode Laser for Harvesting Gingival Graft

Primary Purpose

Gingival Recession

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
diode laser group
scalpel control group
Sponsored by
Cukurova University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession focused on measuring free gingival graft, diode laser, donor site, mucogingival surgery

Eligibility Criteria

21 Years - 38 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cukurova University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Diode laser group

Scalpel control group

Arm Description

In the test sites, an aluminum, gallium, and arsenide diode laser (wavelength 810 nm and power of 1W) was applied in continuous mode.

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 .

Outcomes

Primary Outcome Measures

Oral health related quality of life

Secondary Outcome Measures

Complete root coverage
Smile related quality of life
Post-operative Discomfort on the Visual Analog scale

Full Information

First Posted
April 29, 2015
Last Updated
May 12, 2015
Sponsor
Cukurova University
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1. Study Identification

Unique Protocol Identification Number
NCT02441127
Brief Title
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

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cukurova University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession
Keywords
free gingival graft, diode laser, donor site, mucogingival surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diode laser group
Arm Type
Experimental
Arm Description
In the test sites, an aluminum, gallium, and arsenide diode laser (wavelength 810 nm and power of 1W) was applied in continuous mode.
Arm Title
Scalpel control group
Arm Type
Active Comparator
Arm Description
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 .
Intervention Type
Device
Intervention Name(s)
diode laser group
Intervention Description
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
Procedure
Intervention Name(s)
scalpel control group
Intervention Description
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
Primary Outcome Measure Information:
Title
Oral health related quality of life
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Complete root coverage
Time Frame
6 months
Title
Smile related quality of life
Time Frame
6 months
Title
Post-operative Discomfort on the Visual Analog scale
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Onur Ozcelik, PhD
Organizational Affiliation
Cukurova University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cukurova University
City
Adana
ZIP/Postal Code
01330
Country
Turkey

12. IPD Sharing Statement

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Diode Laser for Harvesting Gingival Graft

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