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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02626117
Enrollment
20
Registered
2015-12-10
Start date
2013-07-31
Completion date
2016-01-31
Last updated
2015-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gingival Recession

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.

Interventions

DEVICELASER deepithelialization

the selected participants were assigned in test and control. Under LA full thickness flap was reflected until the mucogingival junction and recipient area was prepared. The connective tissue graft harvested from palate was placed on the root surface and secured with 5-0 absorbable sutures. 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. The connective tissue graft was placed on the root surface at the level of the CEJ and then secured with 5-0 absorbable sutures in both test and control sites using sling suture..

DEVICESham LASER deepithelialization

the selected participants were assigned in test and control. Under LA full thickness flap was reflected until the mucogingival junction and recipient area was prepared. The connective tissue graft harvested from palate was placed on the root surface and secured with 5-0 absorbable sutures. sham LASER deepithelialisation was applied to the sulcular epithelium. The connective tissue graft was placed on the root surface at the level of the CEJ and then secured with 5-0 absorbable sutures in both test and control sites using sling suture..

Sponsors

Krishnadevaraya College of Dental Sciences & Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
21 Years to 57 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Percentage of root coverage (PRC)6 months
Complete root coverage6 months

Secondary

MeasureTime frame
Probing depth (PD)6 months
Reductions in recession depth (Rec Red)6 months
Keratinized tissue width (KTW)6 months
Clinical attachment level (CAL)6 months
Gingival recession width (GRW)6 months

Countries

India

Contacts

Primary ContactJoann Pauline George, MDS
drjoannpaulinegeorge@gmail.com09448541637
Backup Contactankita jha, BDS
ankita_0901@yahoo.co.in9663597700

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026