Clinical trial NCT02626117: Laser De-epithelialization for Epithelial Exclusion in Root Coverage Procedure: a Clinical Study
Official title: Laser De-epithelialization for Epithelial Exclusion in Root Coverage Procedure: a Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Gingival Recession
Lead sponsor: Krishnadevaraya College of Dental Sciences & Hospital
Sponsor class: OTHER
First posted: 2015-12-10
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 57
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The concept of laser deepithelialization to retard epithelial migration has enabled new attachment formation in periodontal pockets. Based on this hypothesis, that laser deepithelialization during root coverage procedures will enhance clinical outcome, a split mouth randomized controlled clinical trial was planned to compare the clinical outcome of Coronally advanced flap (CAF) + subepithelial connective tissue graft (SCTG) alone and in combination with laser de-epithelialization in the treatment of gingival recession.

Detailed description: Successful treatment of recession defects to obtain new attachment and prevent repair by long junctional epithelium continues to present a serious therapeutic challenge. The concept of laser deepithelialization to retard epithelial migration has enabled new attachment formation in periodontal pockets. Based on this hypothesis, that laser deepithelialization during root coverage procedures will enhance clinical outcome, a split mouth randomized controlled clinical trial was planned to compare the clinical outcome of Coronally advanced flap (CAF) + subepithelial connective tissue graft (SCTG) alone and in combination with laser de-epithelialization in the treatment of gingival recession.

METHOD:

In a split-mouth study, 20 patients presenting at least one pair of bilaterally symmetrical Miller's Class I and Class II buccal gingival recessions will be selected. Control site will receive coronally advanced flap with connective tissue graft and test site will receive laser deepithelialization as an adjunct to coronally advanced flap with connective tissue graft. Gingival recession depth (GRD), Gingival recession width (GRW), Probing depth (PD), Clinical attachment level (CAL), Keratinized tissue width (KTW), Plaque index (PI), Gingival index (GI), Gingival bleeding index (GBI) will be measured at baseline, 6 weeks, 3 months and 6 months after treatment. The root coverage outcomes were also assessed by photogrammetric analysis.

Eligibility criteria: Inclusion Criteria:• Miller's Class I and II recession defects involving maxillary or mandibular canines or premolars.

* Similar bilateral recession defects.
* Systemically healthy patients.
* Patients willing to participate in study.
* Age group of 21-57 years.
* Patients with esthetic concerns.

Exclusion Criteria:

* Pregnant and lactating woman
* Patients who have undergone any type of regenerative periodontal therapy six months prior to the initial examination.
* Patients with history of smoking.
* Teeth with hopeless prognosis.
* Root surface restoration.

Primary outcomes:
measure: Percentage of root coverage (PRC)
timeFrame: 6 months
measure: Complete root coverage
timeFrame: 6 months
Secondary outcomes:
measure: Reductions in recession depth (Rec Red)
timeFrame: 6 months
measure: Gingival recession width (GRW)
timeFrame: 6 months
measure: Probing depth (PD)
timeFrame: 6 months
measure: Clinical attachment level (CAL)
timeFrame: 6 months
measure: Keratinized tissue width (KTW)
timeFrame: 6 months
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Dr Joann Pauline George
state: Karnataka
Study officials:
affiliation: krishnadevaraya college of dental sciences
name: Joann Pauline George, MDS
role: STUDY_DIRECTOR
References:
citation: Nevins ML, Camelo M, Schupbach P, Kim SW, Kim DM, Nevins M. Human clinical and histologic evaluation of laser-assisted new attachment procedure. Int J Periodontics Restorative Dent. 2012 Oct;32(5):497-507.