NCT02876562

Brief Summary

Recently porcine derived bioresorbable collagen matrices have shown predictable outcomes for augmenting keratinzed gingiva , improved wound healing, recession coverage in localized gingival recessions and multiple recession coverage. However there are very few randomized controlled clinical trials in the literature that compare collagen matrix versus connective tissue graft in the management of multiple recession type defects. To the best of our knowledge there is only one randomized controlled trial that compares modified coronally advanced tunnel+connective tissue graft with collagen matrix in the management of multiple gingival recessions. Thus aim of this study will be to compare the effectiveness of collagen versus CTG in the management of Millers class I and II multiple gingival recessions. The use of collagen matrix in combination with Modified Coronally Advanced Tunnel as a surgical technique will be compared for recession coverage.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2016

Completed
27 days until next milestone

First Posted

Study publicly available on registry

August 24, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

December 11, 2017

Status Verified

April 1, 2016

Enrollment Period

1.3 years

First QC Date

July 28, 2016

Last Update Submit

December 8, 2017

Conditions

Gingival Recession

Keywords

Gingival Recession Coverage

Outcome Measures

Primary Outcomes (6)

  • gingival recession depth

    6 months

  • gingival recession width

    6 months

  • complete root coverage

    6 months

  • clinical attachment level

    6 months

  • keratinized tissue width

    6 months

  • probing depth

    6 months

Secondary Outcomes (3)

  • plaque index

    6 months

  • gingival bleeding index

    6 months

  • gingival index

    6 months

Study Arms (2)

root coverage with collagen matrix

EXPERIMENTAL

evaluation of root coverage achieved by collagen matrix in conjunction with modified coronally advanced tunnel in patients with multiple gingival recession

Procedure: root coverage with collagen matrix

root coverage with connective tissue graft

ACTIVE COMPARATOR

evaluation of root coverage achieved by connective tissue graft in conjunction with modified coronally advanced tunnel in patients with multiple gingival recession

Procedure: root coverage with collagen matrix

Interventions

root coverage with collagen matrixPROCEDURE

the material used is a porcine derived native collagen matrix which serves an alternative to connective tissue graft. the material is 1.5 mm in thickness with a specific tissue surface to allow for cell migration and a fibrous outer layer. it has a resorption time of 6 months.

root coverage with collagen matrixroot coverage with connective tissue graft

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>/= 18
  • Patients with thick gingival biotypes(\>0.8mm)24
  • Patients with healthy or treated periodontal conditions.8
  • Patients willing to participate in the study.8
  • Absence of uncontrolled medical conditions25
  • Full mouth plaque score \</= 10%(O'Leary 1972)
  • Patients with esthetic concerns.

You may not qualify if:

  • Pregnant or lactating females 8
  • Tobacco smoking26
  • Uncontrolled medical conditions25
  • Untreated periodontal conditions
  • Use of systemic antibiotics in the past 3 months
  • Patients treated with any medication known to cause gingival hyperplasia8
  • Drug and alcohol abuse8
  • Recession defects associated with occlusal interferences, pulpal pathology, caries/demineralization, restorations and deep abrasions( step\>2mm)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Krishnadevaraya College of Dental Sciences

Bangalore, Karnataka, 562157, India

Location

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2016

First Posted

August 24, 2016

Study Start

November 1, 2015

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

December 11, 2017

Record last verified: 2016-04

Locations

IN(1)