Connective Tissue Graft Versus Mucograft Collagen Matrix for Coverage of Multiple Gingival Recession Defects

Gingival Recession Clinical Trial

Official title:

Connective Tissue Graft vs Mucograft Collagen Matrix for Coverage of Multiple Gingival Recession Defects Randomized Controlled Clinical Trial Assessing Superiority in Health Related Quality of Life and Non-Inferiority in Root Coverage

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01440426
• Other study ID #: ERGOPerio 11-01
• Status: Completed
• Phase: Phase 4
• Start date: September 2011
• Est. completion date: June 2015

Study information

• Verified date: July 2018
• Source: The European Research Group on Periodontology (ERGOPerio)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Objectives The main objective of this study is to assess if the Mucograft Collagen Matrix reduces morbidity, shortens time to recovery and improves patient based outcomes with respect to the use of autologous connective tissue graft harvested from the patient own palate when used to obtain root coverage of multiple adjacent gingival recessions.

The secondary objective is to assess the non-inferiority - in terms of complete root coverage, percentage of root coverage and professional evaluation of aesthetics - of the use of Mucograft Collagen Matrix and autologous connective tissue harvested from the patient's own palate.

Design and Outcomes This will be a parallel group, standard of care-controlled, assessor-blind, randomized, multicenter, multinational, clinical trial.

The statistical design will be a superiority trial in terms of the primary outcomes (patient based outcomes) and non-inferiority trial in terms of the professional outcomes measuring root coverage and aesthetics.

Sample size has been estimated in 140 subjects per treatment arm using a pilot case series analyzed with a multilevel statistical approach and a non inferiority margin of 0.25 mm in recession coverage.

Randomization will be performed by computer generated random codes, using random permuted blocks with a block size of 4 to avoid uneven splits and minimization for the key prognostic factor cigarette smoking. Allocation will be concealed to the surgeons until completion of preparation of the recipient bed by opaque envelopes. A central study registrar will perform patient registration.

Study locations will include academic centers and a practice-based research network in Italy, Switzerland, Germany, Belgium, France, Spain and Greece.

A single examiner, blind with respect to the treatment assignment, will perform all measurements at each center. Trained personnel not involved with the surgical intervention will: i) administer patient questionnaires, ii) provide instructions and collect patient diaries. A single calibrated investigator with specific experience in using the specific score will centrally perform assessment of esthetic scores on standardized digital images.

A biostatistician blind with respect to treatment assignment will perform the analysis.

Interventions and Duration The two intervention groups will consist of surgery with connective tissue graft (standard of care control) and surgery with the application of Mucograft Collagen Matrix (MCM, Test group). Experienced clinicians will deliver treatment consisting of root coverage surgery using coronally advanced flaps, the most utilized procedure for coverage of multiple recessions. Surgery will be standardized and the same procedures/materials will be employed to ensure consistency.

Follow-up of individual patients will be 6 months (to be extended to 3 years if funding will be available)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 187
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 2-4 adjacent gingival recession (one at least 3 mm deep)

Exclusion Criteria:

• Interdental attachment loss greater than 1 mm at recession sites

Related Conditions & MeSH terms

• Gingival Recession

Intervention

Procedure:
• Autologous connective tissue graft with rotated papilla flap
Subepithelial connective tissue graft harvested from hard palate

Device:
• Collagen matrix construct (Mucograft)
Mucograft Collagen Matrix combined with rotated papilla flap

Locations

Country	Name	City	State
Belgium	ICPDOI	Brussels
Germany	Praxis Dr. Halben	Hamburg
Germany	Praxis Prof Huerzeler - Dr Zuhr	Munich
Germany	Praxis Prof Wachtel - Dr Bolz	Munich
Germany	Praxis Prof. Topoll	Munster
Greece	Clinic Fourmousis	Athens
Italy	University of FLorence	Florence
Italy	Practice Prof Giulio Rasperini	Piacenza
Italy	University of Pisa	Pisa
Spain	Clinia Zabalegui	Bilbao
Spain	Clinica Guerrero	Malaga
Switzerland	Praxis Wallkamm	Langenthal
Switzerland	Praxis Burkhardt	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
Maurizio Tonetti	The European Research Group on Periodontology (ERGOPerio)

Countries where clinical trial is conducted

Belgium,  Germany,  Greece,  Italy,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to recovery after surgery	Time to recover after surgery assessed by diary and post'op follow up professional assessment	3 months
Secondary	Complete root coverage	Frequency of complete root coverage	6 months
Secondary	Percentage of root coverage	Percentage of the exposed tooth root covered after surgical intervention	6 months
Secondary	Esthetics	Professional assessment by blind assessor of the esthetic result	6 months