Gingival RecessionPhase 4NCT01440426
Connective Tissue Graft Versus Mucograft Collagen Matrix for Coverage of Multiple Gingival Recession Defects
A Phase 4 study testing Autologous connective tissue graft with rotated papilla flap and Collagen matrix construct (Mucograft) in people with Gingival Recession, run by Maurizio Tonetti at 13 sites in 6 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gingival Recession
- What is being tested?
- Autologous connective tissue graft with rotated papilla flap and Collagen matrix construct (Mucograft)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 187 participants
- Where
- 13 sitesin 6 countries
- Study dates
- Sep 2011to Jun 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 2-4 adjacent gingival recession (one at least 3 mm deep)
Who cannot join
- Interdental attachment loss greater than 1 mm at recession sites
Trial locations and contacts
13 sites in 6 countries.
13 sites in 6 countries
Germany4 sites
Praxis Dr. Halben
Hamburg
Praxis Prof Huerzeler - Dr Zuhr
Munich
Praxis Prof Wachtel - Dr Bolz
Munich
Praxis Prof. Topoll
Münster
Italy3 sites
University of FLorence
Florence
Practice Prof Giulio Rasperini
Piacenza
University of Pisa
Pisa
About this study
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
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.
Read the detailed 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)
- Conditions
- Gingival Recession
- Being tested
- Autologous connective tissue graft with rotated papilla flap, Collagen matrix construct (Mucograft)
- Keywords
- gingival recession, root coverage, periodontal surgery, collagen matrix, mucograft, multiple exposed teeth
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous connective tissue graft with rotated papilla flapProcedure or surgery
Also called Subepithelial connective tissue graft
Subepithelial connective tissue graft harvested from hard palate
Collagen matrix construct (Mucograft)Device
Also called Mucograft gingival augmentation
Mucograft Collagen Matrix combined with rotated papilla flap
| Study group | Role | What they receive |
|---|---|---|
| Autologous connective tissue graft | Active comparator | Soft tissue harvested from patient palate Receives: Procedure: Autologous connective tissue graft with rotated papilla flap |
| Collagen Matrix Construct | Experimental | Mucograft collagen matrix manufactured by Geistlich AG, Switzerland Receives: Device: Collagen matrix construct (Mucograft) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to recovery after surgery
Time to recover after surgery assessed by diary and post'op follow up professional assessment
Measured: 3 months
Secondary outcomes (3)
Complete root coverage
Frequency of complete root coverage
Measured: 6 months
Percentage of root coverage
Percentage of the exposed tooth root covered after surgical intervention
Measured: 6 months
Esthetics
Professional assessment by blind assessor of the esthetic result
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival RecessionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maurizio Tonetti
- Sponsor type
- Research network
- Collaborators
- The European Research Group on Periodontology (ERGOPerio)
- Responsible party
- Sponsor-investigator, Maurizio Tonetti, The European Research Group on Periodontology (ERGOPerio)
- Investigators
- Maurizio Tonetti, DMD PhD, Principal investigator, The European Research Group on Periodontology (ERGOPerio)Pierpaolo COrtellini, MD, Principal investigator, The European Research Group on Periodontology (ERGOPerio)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01440426
- Sponsor's protocol ID
- ERGOPerio 11-01
- Status last verified
- Jul 2018
- First submitted
- 22 Sep 2011
- Last updated
- 13 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01440426
- Acronym / sponsor ID
- ERGOPerio 11-01
- Conditions
- Gingival Recession
- Keywords
- gingival recession, root coverage, periodontal surgery, collagen matrix, mucograft, multiple exposed teeth
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Maurizio TonettiResearch network
- Collaborators
- The European Research Group on Periodontology (ERGOPerio)
- Study start
- Sep 2011
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 26 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autologous connective tissue graft | Active comparator | Procedure: Autologous connective tissue graft with rotated papilla flapSoft tissue harvested from patient palate |
| Collagen Matrix Construct | Experimental | Device: Collagen matrix construct (Mucograft)Mucograft collagen matrix manufactured by Geistlich AG, Switzerland |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 2-4 adjacent gingival recession (one at least 3 mm deep)
Key exclusion criteria (1 listed)
- Interdental attachment loss greater than 1 mm at recession sites
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous connective tissue graft with rotated papilla flapAlso: Subepithelial connective tissue graftSubepithelial connective tissue graft harvested from hard palate | Procedure or surgery | Autologous connective tissue graft |
| Collagen matrix construct (Mucograft)Also: Mucograft gingival augmentationMucograft Collagen Matrix combined with rotated papilla flap | Device | Collagen Matrix Construct |
Primary outcome
Time to recovery after surgery
Time frame: 3 months
Time to recover after surgery assessed by diary and post'op follow up professional assessment
3 secondary outcomes
Complete root coverage
Time frame: 6 months
Percentage of root coverage
Time frame: 6 months
Esthetics
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maurizio Tonetti, DMD PhD principal investigator
The European Research Group on Periodontology (ERGOPerio)
Pierpaolo COrtellini, MD principal investigator
The European Research Group on Periodontology (ERGOPerio)
13 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Autologous connective tissue graft with rotated papilla flap and Collagen matrix construct (Mucograft) in people with Gingival Recession, run by Maurizio Tonetti at 13 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Germany, Italy, Spain, Switzerland, Belgium and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to recovery after surgery (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2018.