Gingival RecessionMCT-RecessionNCT00902876
A Randomized Controlled Clinical Trial to Evaluate Safety and Effectiveness of CAF + Mucograft® Compared to CAF Alone in Patients With Gingival Recessions
A study testing Mucograft and Coronally advanced flap (CAF) in people with Gingival Recession, run by Geistlich Pharma AG at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gingival Recession
- What is being tested?
- Mucograft and Coronally advanced flap (CAF)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2009to Jan 2012
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Clinical Trial to Evaluate Safety and Effectiveness of CAF + Mucograft® Compared to CAF Alone in Patients With Gingival Recessions.
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).
Read the detailed description
Primary goals of mucogingival surgery have changed with time from maintaining gingival health and prevent further progression of the recession to providing predictable root coverage solving patients' esthetic demands.
Many surgical techniques have been utilized to restore gingival tissue dimensions including the use of autologous soft tissue graft. Longitudinal studies have shown that procedures using pedicle and free grafts are both effective for this purpose. However, since this technique uses epithelialized grafts, it generally results in compromised aesthetics ("patch-like area"). Alternatively free connective tissue grafts (CTG) are used providing similar predictability but resulting in better colour matching. Unfortunately, both techniques are associated with significant patient morbidity due to the wound at the palatal donor site. To avoid patient morbidity, acellular dermal allografts have been used as substitutes for palatal donor tissue, demonstrating the possible and promising use of allograft material. However, since the allograft material is derived from human cadavers; it is associated with ethical concerns and the risk of disease transmission.
In patients with a residual amount of keratinized tissue, the coronally advanced flap (CAF) - first introduce by Norber et al. (1926) - has been demonstrated to be very effective in treatment of multiple and single recessions with advantages in terms of aesthetics and morbidity. Although CAF is a safe and predictable approach for root coverage, the application of this surgical technique in conjunction with autologous or synthetic material was reported to enhance the probability to achieve complete root coverage in Miller Class I and II gingival recessions. A promising option to avoid patient morbidity and the use of autologous transplants or allografts is the use of collagen matrices from porcine origin, such as Mucograft®. Similar devices have been extensively used for guided tissue regeneration procedures. Mucograft® provides an ideal matrix for blood vessel and soft tissue ingrowth, which is likely to improve the results and the predictability of recession coverage procedure using the CAF.
- Conditions
- Gingival Recession
- Being tested
- Mucograft, Coronally advanced flap (CAF)
- Keywords
- root coverage, gingival recession, keratinized gingiva
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MucograftDevice
Collagen Matrix for soft tissue regeneration
Coronally advanced flap (CAF)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Mucograft + CAF | Experimental | Mucograft in combination with coronally advanced flap (CAF) Receives: Device: Mucograft |
| CAF | Experimental | Coronally advanced flap (CAF) alone Receives: Procedure: Coronally advanced flap (CAF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of root coverage
Measured: 6 month
Secondary outcomes (1)
gingival thickness
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2009 (estimated)
- Study startMar 2009
- Primary completionJul 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geistlich Pharma AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mariano Sanz, Prof., Principal investigator, Department of Periodontology, University Complutense Madrid, SpainSoren Jepsen, Prof., Principal investigator, Department of Periodontology, University of Bonn, GermanyJan Wennström, Prof., Principal investigator, Department of Periodontology, University of Gothenburg, SwedenGiovanni Zucchelli, Prof., Principal investigator, Department of Periodontology, University of Bologna, ItalyLorenz Uebersax, Dr., Study director, Geistlich Pharma AG, Wolhusen, SwitzerlandBernd Heinz, Dr, Principal investigator, Private practice Hamburg, GermanyMassimo DeSanctis, Prof., Principal investigator, Private Practice Firenze
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00902876
- Sponsor's protocol ID
- 10812-009
- Acronym
- MCT-Recession
- Status last verified
- Feb 2012
- First submitted
- 14 May 2009
- Last updated
- 8 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 28304210
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Clinical Trial to Evaluate Safety and Effectiveness of CAF + Mucograft® Compared to CAF Alone in Patients With Gingival Recessions.
- ClinicalTrials.gov ID
- NCT00902876
- Acronym / sponsor ID
- MCT-Recession / 10812-009
- Conditions
- Gingival Recession
- Keywords
- root coverage, gingival recession, keratinized gingiva
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Geistlich Pharma AGIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 15 May 2009 (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.
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).
Detailed description
Primary goals of mucogingival surgery have changed with time from maintaining gingival health and prevent further progression of the recession to providing predictable root coverage solving patients' esthetic demands.
Many surgical techniques have been utilized to restore gingival tissue dimensions including the use of autologous soft tissue graft. Longitudinal studies have shown that procedures using pedicle and free grafts are both effective for this purpose. However, since this technique uses epithelialized grafts, it generally results in compromised aesthetics ("patch-like area"). Alternatively free connective tissue grafts (CTG) are used providing similar predictability but resulting in better colour matching. Unfortunately, both techniques are associated with significant patient morbidity due to the wound at the palatal donor site. To avoid patient morbidity, acellular dermal allografts have been used as substitutes for palatal donor tissue, demonstrating the possible and promising use of allograft material. However, since the allograft material is derived from human cadavers; it is associated with ethical concerns and the risk of disease transmission.
In patients with a residual amount of keratinized tissue, the coronally advanced flap (CAF) - first introduce by Norber et al. (1926) - has been demonstrated to be very effective in treatment of multiple and single recessions with advantages in terms of aesthetics and morbidity. Although CAF is a safe and predictable approach for root coverage, the application of this surgical technique in conjunction with autologous or synthetic material was reported to enhance the probability to achieve complete root coverage in Miller Class I and II gingival recessions. A promising option to avoid patient morbidity and the use of autologous transplants or allografts is the use of collagen matrices from porcine origin, such as Mucograft®. Similar devices have been extensively used for guided tissue regeneration procedures. Mucograft® provides an ideal matrix for blood vessel and soft tissue ingrowth, which is likely to improve the results and the predictability of recession coverage procedure using the CAF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mucograft + CAF | Experimental | Device: MucograftMucograft in combination with coronally advanced flap (CAF) |
| CAF | Experimental | Procedure: Coronally advanced flap (CAF)Coronally advanced flap (CAF) alone |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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%).
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| MucograftCollagen Matrix for soft tissue regeneration | Device | Mucograft + CAF |
| Coronally advanced flap (CAF) | Procedure or surgery | CAF |
Primary outcome
percentage of root coverage
Time frame: 6 month
1 secondary outcome
gingival thickness
Time frame: 6 month
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 8 Feb 2019.
- Derived from this study: PubMed 28304210Jepsen 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.
Related trials for Gingival Recession
Recruiting
Palatal Wound Healing After Free Gingival Graft Harvest in Diabetic Patients: A Clinical Trial
Diabetes Mellitus, Gingival Recession, Generalized
Not yet recruiting
Evaluation of the Effect of Smoking on Palatal Donor Site Tissue Profile in the Success of Connective Tissue Grafts
Soft Tissue Augmentation, Gingival Recession Localized Moderate
Active, not recruiting
Vertically Coronally Advanced Flap Versus Coronally Advanced Flap for Miller Class I Gingival Recession
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Recruiting
Effects of Low-Level Laser Therapy and Hyaluronic Acid After Free Gingival Graft
Gingival Recession, Mucogingival Surgery
Recruiting
Impact of Root Surface Conditioning With Erythritol Air Polishing and Hand Instrumentation on Recession Coverage Using the Modified Tunnel Technique and Subepithelial Connective Tissue Graft.
Gingival Recession
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.
Mariano Sanz, Prof. principal investigator
Department of Periodontology, University Complutense Madrid, Spain
Soren Jepsen, Prof. principal investigator
Department of Periodontology, University of Bonn, Germany
Jan Wennström, Prof. principal investigator
Department of Periodontology, University of Gothenburg, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mucograft and Coronally advanced flap (CAF) in people with Gingival Recession, run by Geistlich Pharma AG at 1 site in Spain.
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 8 inclusion and 9 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 8 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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.
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?
percentage of root coverage (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00902876, which also lists 1 linked publication.
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 8 Feb 2019.