NCT02441127

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 12, 2015

Completed
Last Updated

May 13, 2015

Status Verified

May 1, 2015

Enrollment Period

1.5 years

First QC Date

April 29, 2015

Last Update Submit

May 12, 2015

Conditions

Gingival Recession

Keywords

free gingival graftdiode laserdonor sitemucogingival surgery

Outcome Measures

Primary Outcomes (1)

  • Oral health related quality of life

    6 months

Secondary Outcomes (3)

  • Complete root coverage

    6 months

  • Smile related quality of life

    6 months

  • Post-operative Discomfort on the Visual Analog scale

    1 month

Study Arms (2)

Diode laser group

EXPERIMENTAL

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

Device: diode laser group

Scalpel control group

ACTIVE COMPARATOR

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 .

Procedure: scalpel control group

Interventions

diode laser groupDEVICE

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.

Diode laser group
scalpel control groupPROCEDURE

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

Scalpel control group

Eligibility Criteria

Age21 Years - 38 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • History of periodontitis or abscess formation
  • Presence of systemic disease
  • Smokers
  • Pregnant patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cukurova University

Adana, 01330, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Officials

  • Onur Ozcelik, PhD

    Cukurova University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 29, 2015

First Posted

May 12, 2015

Study Start

October 1, 2012

Primary Completion

April 1, 2014

Study Completion

November 1, 2014

Last Updated

May 13, 2015

Record last verified: 2015-05

Locations

TU(1)