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Laser De-epithelialization for Epithelial Exclusion in Root Coverage Procedure: a Clinical Study

Phase 4
Conditions
Gingival Recession
Interventions
Device: LASER deepithelialization
Device: Sham LASER deepithelialization
Registration Number
NCT02626117
Lead Sponsor
Krishnadevaraya College of Dental Sciences & Hospital
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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
20
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
CAF+ SCTG+ laser depithelialisationLASER deepithelializationCAF + SCTG and Diode (GaAlAs) laser with a wavelength of 820 nm and a power of 1.5 watt in a continuous mode was applied to remove the sulcular epithelium.
CAF+SCTG+ sham laser depithelialisationSham LASER deepithelializationCAF+ SCTG+ sham LASER deepithelialisation was applied to remove the sulcular epithelium.
Primary Outcome Measures
NameTimeMethod
Percentage of root coverage (PRC)6 months
Complete root coverage6 months
Secondary Outcome Measures
NameTimeMethod
Clinical attachment level (CAL)6 months
Keratinized tissue width (KTW)6 months
Reductions in recession depth (Rec Red)6 months
Gingival recession width (GRW)6 months
Probing depth (PD)6 months

Trial Locations

Locations (1)

Dr Joann Pauline George

🇮🇳

Bangalore, Karnataka, India

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