NCT01440426

Brief Summary

This study deals with coverage of multiple denuded roots. The current standard treatment requires surgical correction and uses soft tissue taken from the roof of the mouth to enhance results. The hypothesis of this trial is that a synthetic collagen matrix (called Mucograft) can be used to replace soft tissue taken from the subject. If the collagen matrix will prove to be equally as effective as the patient own tissue, it will be possible to avoid a more extensive surgery and decrease pain and discomfort.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
187

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2011

Longer than P75 for phase_4

Geographic Reach
6 countries

13 active sites

Status
completed

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

September 1, 2011

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

September 22, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 26, 2011

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

July 13, 2018

Status Verified

July 1, 2018

Enrollment Period

3.8 years

First QC Date

September 22, 2011

Last Update Submit

July 12, 2018

Conditions

Gingival Recession

Keywords

gingival recessionroot coverageperiodontal surgerycollagen matrixmucograftmultiple exposed teeth

Outcome Measures

Primary Outcomes (1)

  • Time to recovery after surgery

    Time to recover after surgery assessed by diary and post'op follow up professional assessment

    3 months

Secondary Outcomes (3)

  • Complete root coverage

    6 months

  • Percentage of root coverage

    6 months

  • Esthetics

    6 months

Study Arms (2)

Autologous connective tissue graft

ACTIVE COMPARATOR

Soft tissue harvested from patient palate

Procedure: Autologous connective tissue graft with rotated papilla flap

Collagen Matrix Construct

EXPERIMENTAL

Mucograft collagen matrix manufactured by Geistlich AG, Switzerland

Device: Collagen matrix construct (Mucograft)

Interventions

Autologous connective tissue graft with rotated papilla flapPROCEDURE

Subepithelial connective tissue graft harvested from hard palate

Also known as: Subepithelial connective tissue graft
Autologous connective tissue graft
Collagen matrix construct (Mucograft)DEVICE

Mucograft Collagen Matrix combined with rotated papilla flap

Also known as: Mucograft gingival augmentation
Collagen Matrix Construct

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adjacent gingival recession (one at least 3 mm deep)

You may not qualify if:

  • Interdental attachment loss greater than 1 mm at recession sites

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

ICPDOI

Brussels, Belgium

Location

Praxis Dr. Halben

Hamburg, Germany

Location

Praxis Prof Huerzeler - Dr Zuhr

Munich, Germany

Location

Praxis Prof Wachtel - Dr Bolz

Munich, Germany

Location

Praxis Prof. Topoll

Münster, Germany

Location

Clinic Fourmousis

Athens, Greece

Location

University of FLorence

Florence, Italy

Location

Practice Prof Giulio Rasperini

Piacenza, Italy

Location

University of Pisa

Pisa, Italy

Location

Clinia Zabalegui

Bilbao, Spain

Location

Clinica Guerrero

Málaga, Spain

Location

Praxis Wallkamm

Langenthal, Switzerland

Location

Praxis Burkhardt

Zurich, Switzerland

Location

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Officials

  • Maurizio Tonetti, DMD PhD

    The European Research Group on Periodontology (ERGOPerio)

    PRINCIPAL INVESTIGATOR

  • Pierpaolo COrtellini, MD

    The European Research Group on Periodontology (ERGOPerio)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Executive DIrector

Study Record Dates

First Submitted

September 22, 2011

First Posted

September 26, 2011

Study Start

September 1, 2011

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

July 13, 2018

Record last verified: 2018-07

Locations

BE(1)GR(1)DE(4)IT(3)ES(2)CH(2)