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

Primary Purpose

Gingival Recession

Status
Unknown status
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
LASER deepithelialization
Sham LASER deepithelialization
Sponsored by
Krishnadevaraya College of Dental Sciences & Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession

Eligibility Criteria

21 Years - 57 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Dr Joann Pauline GeorgeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

CAF+ SCTG+ laser depithelialisation

CAF+SCTG+ sham laser depithelialisation

Arm 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.

CAF+ SCTG+ sham LASER deepithelialisation was applied to remove the sulcular epithelium.

Outcomes

Primary Outcome Measures

Percentage of root coverage (PRC)
Complete root coverage

Secondary Outcome Measures

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

Full Information

First Posted
December 1, 2015
Last Updated
December 7, 2015
Sponsor
Krishnadevaraya College of Dental Sciences & Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02626117
Brief Title
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

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
July 2013 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
January 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Krishnadevaraya College of Dental Sciences & Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CAF+ SCTG+ laser depithelialisation
Arm Type
Active Comparator
Arm 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.
Arm Title
CAF+SCTG+ sham laser depithelialisation
Arm Type
Sham Comparator
Arm Description
CAF+ SCTG+ sham LASER deepithelialisation was applied to remove the sulcular epithelium.
Intervention Type
Device
Intervention Name(s)
LASER deepithelialization
Intervention Description
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..
Intervention Type
Device
Intervention Name(s)
Sham LASER deepithelialization
Intervention Description
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..
Primary Outcome Measure Information:
Title
Percentage of root coverage (PRC)
Time Frame
6 months
Title
Complete root coverage
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Reductions in recession depth (Rec Red)
Time Frame
6 months
Title
Gingival recession width (GRW)
Time Frame
6 months
Title
Probing depth (PD)
Time Frame
6 months
Title
Clinical attachment level (CAL)
Time Frame
6 months
Title
Keratinized tissue width (KTW)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
57 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joann Pauline George, MDS
Phone
09448541637
Email
drjoannpaulinegeorge@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
ankita jha, BDS
Phone
9663597700
Email
ankita_0901@yahoo.co.in
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joann Pauline George, MDS
Organizational Affiliation
krishnadevaraya college of dental sciences
Official's Role
Study Director
Facility Information:
Facility Name
Dr Joann Pauline George
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
562157
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joann pauline george, mds
Phone
9448541637
Email
dr.joannpaulinegeorge@gmail.com
First Name & Middle Initial & Last Name & Degree
ankita jha, bds
Phone
09663597700
Email
ankita_0901@yahoo.co.in

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22754897
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.
Results Reference
background
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed
Description
reference article

Learn more about this trial

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

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