NCT00902876

Brief Summary

The purpose of this multi-center study is to determine the efficacy and safety of Mucograft® in combination with the coronally advanced flap (CAF) for the treatment of gingival recessions. It is assumed that the CAF combined with Mucograft® will result in improved outcome in terms percentage of root coverage and soft tissue thickness in comparison to CAF alone (control).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2009

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 15, 2009

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

February 8, 2019

Status Verified

February 1, 2012

Enrollment Period

2.3 years

First QC Date

May 14, 2009

Last Update Submit

February 6, 2019

Conditions

Gingival Recession

Keywords

root coveragegingival recessionkeratinized gingiva

Outcome Measures

Primary Outcomes (1)

  • percentage of root coverage

    6 month

Secondary Outcomes (1)

  • gingival thickness

    6 month

Study Arms (2)

Mucograft + CAF

EXPERIMENTAL

Mucograft in combination with coronally advanced flap (CAF)

Device: Mucograft

CAF

EXPERIMENTAL

Coronally advanced flap (CAF) alone

Procedure: Coronally advanced flap (CAF)

Interventions

MucograftDEVICE

Collagen Matrix for soft tissue regeneration

Mucograft + CAF
Coronally advanced flap (CAF)PROCEDURE
CAF

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patient (male or female) must be 18 years or older
  • The patient must be a candidate for bilateral root coverage procedure
  • Recession defects are Miller Class I-II and do not vary more than 2 mm.
  • At least one mm keratinized tissue is present.
  • Patient shows sufficient plaque control (FMPS \< 20%).
  • If patient is of child-bearing potential, the patient confirms not to be pregnant and agrees to take contraception for at least 6 months after surgery.
  • The patient is able to comply with the study-related procedures such as exercising good oral hygiene and attending all follow-up procedures
  • The patient is able to fully understand the nature of the proposed surgery and is able to provide a signed informed consent.

You may not qualify if:

  • Patient is a heavy smoker (\> 10 cigarettes per day)
  • Patient is an insulin dependent diabetic
  • General contraindications for dental and/or surgical treatment are present.
  • The patient has a history of malignancy, radiotherapy, or chemotherapy for malignancy within the past five years.
  • The patient is pregnant or nursing
  • The patient is taking medications or having treatments which have an effect on mucosal healing in general (e.g. steroids, large doses of anti-inflammatory drugs).
  • The patient has a disease, which affects connective tissue metabolism (e.g. collagenases).
  • The patient is allergic to collagen.
  • Patients have participated in a clinical trial within the last six months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prof. Mariano Sanz

Madrid, 2804, Spain

Location

Related Publications (1)

  • Jepsen K, Stefanini M, Sanz M, Zucchelli G, Jepsen S. Long-Term Stability of Root Coverage by Coronally Advanced Flap Procedures. J Periodontol. 2017 Jul;88(7):626-633. doi: 10.1902/jop.2017.160767. Epub 2017 Mar 17.

    PMID: 28304210DERIVED

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Officials

  • Mariano Sanz, Prof.

    Department of Periodontology, University Complutense Madrid, Spain

    PRINCIPAL INVESTIGATOR

  • Soren Jepsen, Prof.

    Department of Periodontology, University of Bonn, Germany

    PRINCIPAL INVESTIGATOR

  • Jan Wennström, Prof.

    Department of Periodontology, University of Gothenburg, Sweden

    PRINCIPAL INVESTIGATOR

  • Giovanni Zucchelli, Prof.

    Department of Periodontology, University of Bologna, Italy

    PRINCIPAL INVESTIGATOR

  • Lorenz Uebersax, Dr.

    Geistlich Pharma AG, Wolhusen, Switzerland

    STUDY DIRECTOR

  • Bernd Heinz, Dr

    Private practice Hamburg, Germany

    PRINCIPAL INVESTIGATOR

  • Massimo DeSanctis, Prof.

    Private Practice Firenze

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 14, 2009

First Posted

May 15, 2009

Study Start

March 1, 2009

Primary Completion

July 1, 2011

Study Completion

January 1, 2012

Last Updated

February 8, 2019

Record last verified: 2012-02

Locations

ES(1)