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

Gingival Recession Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT02626117
• Other study ID #: 02_D012_36651
• Status: Unknown status
• Phase: Phase 4
• First received: December 1, 2015
• Last updated: December 7, 2015
• Start date: July 2013
• Est. completion date: January 2016

Study information

• Verified date: September 2015
• Source: Krishnadevaraya College of Dental Sciences & Hospital
• Contact: Joann Pauline George, MDS
• Phone: 09448541637
• Email: drjoannpaulinegeorge[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Unknown status
• Enrollment: 20
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 57 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gingival Recession

Intervention

Device:
• 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. 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..
• Sham 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..

Locations

Country	Name	City	State
India	Dr Joann Pauline George	Bangalore	Karnataka

Sponsors (1)

Lead Sponsor	Collaborator
Krishnadevaraya College of Dental Sciences & Hospital

Country where clinical trial is conducted

India, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of root coverage (PRC)		6 months
Primary	Complete root coverage		6 months
Secondary	Reductions in recession depth (Rec Red)		6 months
Secondary	Gingival recession width (GRW)		6 months
Secondary	Probing depth (PD)		6 months
Secondary	Clinical attachment level (CAL)		6 months
Secondary	Keratinized tissue width (KTW)		6 months

External Links

•   reference article