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

K

Krishnadevaraya College of Dental Sciences & Hospital

Status and phase

Unknown
Phase 4

Conditions

Gingival Recession

Treatments

Device: LASER deepithelialization
Device: Sham LASER deepithelialization

Study type

Interventional

Funder types

Other

Identifiers

NCT02626117
02_D012_36651

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

21 to 57 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

20 participants in 2 patient groups

CAF+ SCTG+ laser depithelialisation
Active Comparator group
Description:
CAF + 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.
Treatment:
Device: LASER deepithelialization
CAF+SCTG+ sham laser depithelialisation
Sham Comparator group
Description:
CAF+ SCTG+ sham LASER deepithelialisation was applied to remove the sulcular epithelium.
Treatment:
Device: Sham LASER deepithelialization

Trial contacts and locations

1

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Central trial contact

ankita jha, BDS; Joann Pauline George, MDS

Data sourced from clinicaltrials.gov

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