Gingival RecessionNCT02632240
Collagen Matrix With Tunnel Technique Compared to CTG for the Treatment of Periodontal Recessions
A study testing Surgery:The tunnel technique for covering gingival recession in people with Gingival Recession, run by Medical University of Silesia at 1 site in Poland.
Trial summary
The aim of this study is to compare the efficacy of dental root coverage using the tunnel technique with connective tissue graft (CTG) and the same technique with collagen matrix for treatment of multiple gingival recessions Miller Class I and II. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Gingival Recession
- What is being tested?
- Surgery:The tunnel technique for covering gingival recession
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 sitePoland
- Study dates
- Oct 2014to Apr 2015
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Presence of minimum two adjacent periodontal recessions Miller class I or II and at least 2 mm recessions depth.
Who cannot join
- Approximal Plaque Index (API) > 15%,
- Sulcus Bleeding Index (SBI) > 10%,
- Systemic diseases with compromised healing potential or infectious diseases,
- Untreated periodontal conditions,
- Pregnant and lactating females.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Collagen Matrix With Tunnel Technique Compared to CTG for the Treatment of Periodontal Recessions - Randomized Clinical Trial
The aim of this study is to compare the efficacy of dental root coverage using the tunnel technique with connective tissue graft (CTG) and the same technique with collagen matrix for treatment of multiple gingival recessions Miller Class I and II.
This study is a randomized-controlled clinical trial of 6 months duration.
Read the detailed description
According to the medical databases, there are limited randomized clinical trials comparing xenogenic collagen matrix and CTG used with the tunnel technique. The collagen matrix is a possible alternative to connective tissue graft.
The purpose of this clinical study is to compare short-term (3-6 months) outcomes of a root coverage using the tunnel technique with the collagen matrix and the same technique with CTG for the treatment of multiple recessions Miller class I and II.
Twenty eight patients are enrolled in the study. Patients in the test group are treated with xenogenic collagen matrix using the tunnel technique whereas patients in the control group with CTG. Clinical recordings are obtained at baseline and after 3 and 6 months. The percentage of average recession coverage (ARC) is evaluated after 3 and 6 months after the surgery.
- Conditions
- Gingival Recession
- Being tested
- Surgery:The tunnel technique for covering gingival recession
- Keywords
- gingival recession, mucogingival surgery, collagen matrix, connective tissue graft, tunnel technique
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery:The tunnel technique for covering gingival recessionOther
The surgery starts with the sulcular incisions in the region of recessions, which enable access for the supraperiosteal preparation. The procedure is extended into the mucosal tissue using the tunneling knives. The partial-thickness flap is performed at the buccal site. Only the papillary regions are fully detached with the periosteum. The graft is placed into the tunnel and stabilized with absorbable sutures.The mobilized mucous flap is advanced coronally and stabilized with non-absorbable suspensory sutures.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Surgery:The tunnel technique for covering gingival recession. Graft: connective tissue. Receives: Other: Surgery:The tunnel technique for covering gingival recession |
| Study group | Active comparator | Surgery:The tunnel technique for covering gingival recession.Graft: xenogenic collagen matrix (Mucoderm). Receives: Other: Surgery:The tunnel technique for covering gingival recession |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical attachment level (CAL)
Distance from the cemento enamel junction to the deepest point of the gingival sulcus
Measured: 6 months
Secondary outcomes (6)
Recession depth (RD)
Distance from the mid-facial point of the cemento-enamel junction to the free gingival margin
Measured: 6 months
Recession width (RW)
Recession width horizontally at cemento-enamel junction level
Measured: 6 months
Width of keratinized tissue (KTW)
Distance from the mucogingival junction to the gingival margin
Measured: 6 months
Recession area (RA)
The area of a triangle with a width of recession as the base and a depth of the recession as the height.
Measured: 6 months
the average percentage of root coverage (ARC)
The percentage of covered recession area.
Measured: 6 months
The complete coverage of recessions (CRC)
The percentage rate of patients with complete coverage of all recessions (CRC)
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 posted16 Dec 2015 (estimated)
- Study startOct 2014
- Primary completionApr 2015
- Study completionApr 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Silesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lukasz Gilowski, Medical University of Silesia
- Investigators
- Marta Tanasiewicz, Professor, Study chair, Department of Conservative Dentistry with Endodontics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02632240
- Sponsor's protocol ID
- KNW-1-072/N/3/0
- Status last verified
- Dec 2015
- First submitted
- 13 Dec 2015
- Last updated
- 18 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collagen Matrix With Tunnel Technique Compared to CTG for the Treatment of Periodontal Recessions - Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02632240
- Acronym / sponsor ID
- KNW-1-072/N/3/0
- Conditions
- Gingival Recession
- Keywords
- gingival recession, mucogingival surgery, collagen matrix, connective tissue graft, tunnel technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Medical University of SilesiaUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 16 Dec 2015 (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 aim of this study is to compare the efficacy of dental root coverage using the tunnel technique with connective tissue graft (CTG) and the same technique with collagen matrix for treatment of multiple gingival recessions Miller Class I and II.
This study is a randomized-controlled clinical trial of 6 months duration.
Detailed description
According to the medical databases, there are limited randomized clinical trials comparing xenogenic collagen matrix and CTG used with the tunnel technique. The collagen matrix is a possible alternative to connective tissue graft.
The purpose of this clinical study is to compare short-term (3-6 months) outcomes of a root coverage using the tunnel technique with the collagen matrix and the same technique with CTG for the treatment of multiple recessions Miller class I and II.
Twenty eight patients are enrolled in the study. Patients in the test group are treated with xenogenic collagen matrix using the tunnel technique whereas patients in the control group with CTG. Clinical recordings are obtained at baseline and after 3 and 6 months. The percentage of average recession coverage (ARC) is evaluated after 3 and 6 months after the surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Surgery:The tunnel technique for covering gingival recessionSurgery:The tunnel technique for covering gingival recession. Graft: connective tissue. |
| Study group | Active comparator | Other: Surgery:The tunnel technique for covering gingival recessionSurgery:The tunnel technique for covering gingival recession.Graft: xenogenic collagen matrix (Mucoderm). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Presence of minimum two adjacent periodontal recessions Miller class I or II and at least 2 mm recessions depth.
Key exclusion criteria (5 listed)
- Approximal Plaque Index (API) > 15%,
- Sulcus Bleeding Index (SBI) > 10%,
- Systemic diseases with compromised healing potential or infectious diseases,
- Untreated periodontal conditions,
- Pregnant and lactating females.
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 |
|---|---|---|
| Surgery:The tunnel technique for covering gingival recessionThe surgery starts with the sulcular incisions in the region of recessions, which enable access for the supraperiosteal preparation. The procedure is extended into the mucosal tissue using the tunneling knives. The partial-thickness flap is performed at the buccal site. Only the papillary regions are fully detached with the periosteum. The graft is placed into the tunnel and stabilized with absorbable sutures.The mobilized mucous flap is advanced coronally and stabilized with non-absorbable suspensory sutures. | Other | Control group, Study group |
Primary outcome
Clinical attachment level (CAL)
Time frame: 6 months
Distance from the cemento enamel junction to the deepest point of the gingival sulcus
6 secondary outcomes
Recession depth (RD)
Time frame: 6 months
Recession width (RW)
Time frame: 6 months
Width of keratinized tissue (KTW)
Time frame: 6 months
Recession area (RA)
Time frame: 6 months
the average percentage of root coverage (ARC)
Time frame: 6 months
The complete coverage of recessions (CRC)
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 18 Dec 2015.
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
Gingival Recession
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.
Marta Tanasiewicz, Professor study chair
Department of Conservative Dentistry with Endodontics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgery:The tunnel technique for covering gingival recession in people with Gingival Recession, run by Medical University of Silesia at 1 site in Poland.
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 5 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 18 Dec 2015. 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 Poland. 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?
Clinical attachment level (CAL) (time frame: 6 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 18 Dec 2015.