NCT02626117

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2013

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

December 1, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 10, 2015

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

December 10, 2015

Status Verified

September 1, 2015

Enrollment Period

2.4 years

First QC Date

December 1, 2015

Last Update Submit

December 7, 2015

Conditions

Gingival Recession

Outcome Measures

Primary Outcomes (2)

  • Percentage of root coverage (PRC)

    6 months

  • Complete root coverage

    6 months

Secondary Outcomes (5)

  • Reductions in recession depth (Rec Red)

    6 months

  • Gingival recession width (GRW)

    6 months

  • Probing depth (PD)

    6 months

  • Clinical attachment level (CAL)

    6 months

  • Keratinized tissue width (KTW)

    6 months

Study Arms (2)

CAF+ SCTG+ laser depithelialisation

ACTIVE COMPARATOR

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.

Device: LASER deepithelialization

CAF+SCTG+ sham laser depithelialisation

SHAM COMPARATOR

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

Device: Sham LASER deepithelialization

Interventions

LASER deepithelializationDEVICE

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..

CAF+ SCTG+ laser depithelialisation
Sham LASER deepithelializationDEVICE

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..

CAF+SCTG+ sham laser depithelialisation

Eligibility Criteria

Age21 Years - 57 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Similar bilateral recession defects.
  • Systemically healthy patients.
  • Patients willing to participate in study.
  • Age group of 21-57 years.
  • Patients with esthetic concerns.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr Joann Pauline George

Bangalore, Karnataka, 562157, India

RECRUITING

Related 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.

    PMID: 22754897BACKGROUND

Related Links

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Officials

  • Joann Pauline George, MDS

    krishnadevaraya college of dental sciences

    STUDY DIRECTOR

Central Study Contacts

Joann Pauline George, MDS

CONTACT

09448541637drjoannpaulinegeorge@gmail.com

ankita jha, BDS

CONTACT

9663597700ankita_0901@yahoo.co.in

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2015

First Posted

December 10, 2015

Study Start

July 1, 2013

Primary Completion

December 1, 2015

Study Completion

January 1, 2016

Last Updated

December 10, 2015

Record last verified: 2015-09

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)