Gingival RecessionNCT02876562
A Comparision of Collagen Matrix and Connective Tissue Graft With Modified Coronally Advanced Tunnel for Root Coverage
A study testing root coverage with collagen matrix in people with Gingival Recession, run by Krishnadevaraya College of Dental Sciences & Hospital at 1 site in India.
Trial summary
Recently porcine derived bioresorbable collagen matrices have shown predictable outcomes for augmenting keratinzed gingiva , improved wound healing, recession coverage in localized gingival recessions and multiple recession coverage. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- root coverage with collagen matrix
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteIndia
- Study dates
- Nov 2015to Feb 2017
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- • Pregnant or lactating females 8
- Tobacco smoking26
- Uncontrolled medical conditions25
- Untreated periodontal conditions
- Use of systemic antibiotics in the past 3 months
- Patients treated with any medication known to cause gingival hyperplasia8
- Drug and alcohol abuse8
- Recession defects associated with occlusal interferences, pulpal pathology, caries/demineralization, restorations and deep abrasions( step>2mm)
Trial locations and contacts
1 site in 1 country.
India1 site
Krishnadevaraya College of Dental Sciences
Bangalore, Karnataka, 562157
About this study
Official title: Comparitive Evaluation of Modified Coronally Advanced Tunnel Collagen Matrix Versus Connective Tissue Graft for Root Coverage in Multiple Gingival Recessions-A Randomised Controlled Clinical Trial
Recently porcine derived bioresorbable collagen matrices have shown predictable outcomes for augmenting keratinzed gingiva , improved wound healing, recession coverage in localized gingival recessions and multiple recession coverage.
However there are very few randomized controlled clinical trials in the literature that compare collagen matrix versus connective tissue graft in the management of multiple recession type defects. To the best of our knowledge there is only one randomized controlled trial that compares modified coronally advanced tunnel+connective tissue graft with collagen matrix in the management of multiple gingival recessions.
Thus aim of this study will be to compare the effectiveness of collagen versus CTG in the management of Millers class I and II multiple gingival recessions. The use of collagen matrix in combination with Modified Coronally Advanced Tunnel as a surgical technique will be compared for recession coverage.
Read the detailed description
Gingival recession is defined as the displacement of the soft tissue margin apical to cementoenamel junction and it may affect single or multiple root surfaces. Gingival recessions are known to compromise esthetic appearance, hinder plaque control, and result in higher susceptibility to hypersensitivity and root caries.
It can be the result of different predisposing anatomic features such as thin gingival biotype, buccal prominence of teeth, lack of keratinized tissue, high frenal attachment, or patient related factors such as vigorous brushing or chronic gingival inflammation. Recessions may be localized or generalized. Alternatively they have been classified into four classes on the basis of extent. Miller's Class I and Class II recession defects mainly occur in multiple buccal areas and the main etiologic factors include trauma from tooth brushing. Miller's Class III and Class IV recessions usually involve the whole mouth and is often related to plaque associated chronic inflammatory periodontal disease. Because of their traumatic etiology, multiple recessions are more frequent.
It has been extensively demonstrated that in Miller's Class I and II single recessions, complete root coverage can be predictably achieved with various techniques. On the other hand, treatment of multiple adjacent gingival recessions is still a challenge for the clinician as in these cases the management of soft tissues becomes more difficult and the wound healing may be compromised by various factors such as width of avascular surface, limited blood supply, differences in the recession depth and position of the teeth. The ultimate goal of root coverage procedures is the complete coverage of the recession defect, with good esthetics and harmonious integration of the covering tissues and with minimal probing depths after treatment.
A variety of surgical procedures have been used to cover exposed root surfaces such as Laterally Positioned Flap, Coronally Advanced Flap, Modified Coronally Advanced Flap, Coronally Advanced Tunnel, Modified Coronally Advanced Tunnel, Subepithelial Connective Tissue Graft(SCTG), Acellular Dermal Matrix(ADMA) and Guided Tissue Regeneration.
Coronally advanced flap (CAF) and SCTG are the most predictable techniques, achieving up to 100% root coverage. CAF alone and with various modifications have been used widely and successfully. Studies have stated that SCTG has not only the highest percentage of mean root coverage but also least variability. In spite of its promising results, SCTG has its own limitations, such as lack of graft availability, need for a second surgical site, proximity to palatine neurovascular complex and unesthetic contour at the recipient site. In some cases, harvesting connective tissue may be difficult in the presence of a flat palatal profile or if thickness of masticatory mucosa appears too thin. The additional chair time must also be considered and compared with that needed to perform a CAF alone. But it has been noted in various studies that CAF alone is not as effective as CAF with CTG, which leads to the attempt of finding an alternative to CTG with all the benefits and none of its drawbacks.
Variants such as membranes, biologic modifiers, and allografts have been developed and tested as substitutes for CTG. Collagen matrix(CM), composed of non-crosslinked porcine collagen, is one such substitute. The matrix is intended to support 3D soft tissue regeneration by favouring blood clot stabilization and early vascularization by its excellent tissue integration. It consists of a superficial cell occlusive layer, and a deeper porous layer. The primary importance of CM lies in that it functions almost as well as CTG in procedures for root coverage and those performed to increase the dimensions of keratinized gingiva, at the same time avoiding all the negatives of the latter. The additional advantages of CM is its influence on the healing cascade and reduced scar retraction. Also it leads to increased thickness of keratinized gingiva thus remedying one of the etiolgical factors of gingival recession. The advent of such materials could have a revolutionary impact within the field of periodontics.
But this merits further research and study in this direction to clarify the position of collagen matrices as a substitute for CTG in periodontal plastic surgeries. Therefore the need for this study is to evaluate the efficacy of collagen matrix as a definitive alternative for CTG and if it will be able to supplant CTG as the most effective method to treat gingival recessions.
Tunnel technique in perioplastic surgery was first introduced by Allen in 1994 , and followed by modifications by Zabalegui(1999), Modified Coronally Advanced Tunnel(MCAT), and Microsurgical CAT. All these techniques have shown remarkable success with root coverage. MCAT technique has certain advantages over CAF/ Modified CAF as the vascular supply of the coronally advanced component is not compromised due to avoidance of vertical/ horizontal incisions.
Recently porcine derived bioresorbable collagen matrices have shown predictable outcomes for augmenting keratinzed gingiva, improved wound healing, recession coverage in localized gingival recession and multiple recession coverage.
However there are very few randomized controlled clinical trials in the literature that compare collagen matrix versus CTG in the management of MRTDs. To the best of our knowledge there is only one RCT that compares MCAT+CTG with MCAT+CM in the management of multiple gingival recessions.
Thus aim of this study will be to compare the effectiveness of collagen versus CTG in the management of Millers class I and II multiple gingival recessions. The use of collagen matrix in combination with Modified Coronally Advanced Tunnel as a surgical technique will be compared for recession coverage.
- Conditions
- Gingival Recession
- Being tested
- root coverage with collagen matrix
- Keywords
- Gingival Recession Coverage
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
root coverage with collagen matrixProcedure or surgery
the material used is a porcine derived native collagen matrix which serves an alternative to connective tissue graft. the material is 1.5 mm in thickness with a specific tissue surface to allow for cell migration and a fibrous outer layer. it has a resorption time of 6 months.
| Study group | Role | What they receive |
|---|---|---|
| root coverage with collagen matrix | Experimental | evaluation of root coverage achieved by collagen matrix in conjunction with modified coronally advanced tunnel in patients with multiple gingival recession Receives: Procedure: root coverage with collagen matrix |
| root coverage with connective tissue graft | Active comparator | evaluation of root coverage achieved by connective tissue graft in conjunction with modified coronally advanced tunnel in patients with multiple gingival recession Receives: Procedure: root coverage with collagen matrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
gingival recession depth
Measured: 6 months
gingival recession width
Measured: 6 months
complete root coverage
Measured: 6 months
clinical attachment level
Measured: 6 months
keratinized tissue width
Measured: 6 months
probing depth
Measured: 6 months
Secondary outcomes (3)
plaque index
Measured: 6 months
gingival bleeding index
Measured: 6 months
gingival index
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 posted24 Aug 2016 (estimated)
- Study startNov 2015
- Primary completionFeb 2017
- Study completionFeb 2017
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
- Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02876562
- Sponsor's protocol ID
- 02_D012_63804
- Status last verified
- Apr 2016
- First submitted
- 28 Jul 2016
- Last updated
- 11 Dec 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparitive Evaluation of Modified Coronally Advanced Tunnel Collagen Matrix Versus Connective Tissue Graft for Root Coverage in Multiple Gingival Recessions-A Randomised Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02876562
- Acronym / sponsor ID
- 02_D012_63804
- Conditions
- Gingival Recession
- Keywords
- Gingival Recession Coverage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & HospitalUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 24 Aug 2016 (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.
Recently porcine derived bioresorbable collagen matrices have shown predictable outcomes for augmenting keratinzed gingiva , improved wound healing, recession coverage in localized gingival recessions and multiple recession coverage.
However there are very few randomized controlled clinical trials in the literature that compare collagen matrix versus connective tissue graft in the management of multiple recession type defects. To the best of our knowledge there is only one randomized controlled trial that compares modified coronally advanced tunnel+connective tissue graft with collagen matrix in the management of multiple gingival recessions.
Thus aim of this study will be to compare the effectiveness of collagen versus CTG in the management of Millers class I and II multiple gingival recessions. The use of collagen matrix in combination with Modified Coronally Advanced Tunnel as a surgical technique will be compared for recession coverage.
Detailed description
Gingival recession is defined as the displacement of the soft tissue margin apical to cementoenamel junction and it may affect single or multiple root surfaces. Gingival recessions are known to compromise esthetic appearance, hinder plaque control, and result in higher susceptibility to hypersensitivity and root caries.
It can be the result of different predisposing anatomic features such as thin gingival biotype, buccal prominence of teeth, lack of keratinized tissue, high frenal attachment, or patient related factors such as vigorous brushing or chronic gingival inflammation. Recessions may be localized or generalized. Alternatively they have been classified into four classes on the basis of extent. Miller's Class I and Class II recession defects mainly occur in multiple buccal areas and the main etiologic factors include trauma from tooth brushing. Miller's Class III and Class IV recessions usually involve the whole mouth and is often related to plaque associated chronic inflammatory periodontal disease. Because of their traumatic etiology, multiple recessions are more frequent.
It has been extensively demonstrated that in Miller's Class I and II single recessions, complete root coverage can be predictably achieved with various techniques. On the other hand, treatment of multiple adjacent gingival recessions is still a challenge for the clinician as in these cases the management of soft tissues becomes more difficult and the wound healing may be compromised by various factors such as width of avascular surface, limited blood supply, differences in the recession depth and position of the teeth. The ultimate goal of root coverage procedures is the complete coverage of the recession defect, with good esthetics and harmonious integration of the covering tissues and with minimal probing depths after treatment.
A variety of surgical procedures have been used to cover exposed root surfaces such as Laterally Positioned Flap, Coronally Advanced Flap, Modified Coronally Advanced Flap, Coronally Advanced Tunnel, Modified Coronally Advanced Tunnel, Subepithelial Connective Tissue Graft(SCTG), Acellular Dermal Matrix(ADMA) and Guided Tissue Regeneration.
Coronally advanced flap (CAF) and SCTG are the most predictable techniques, achieving up to 100% root coverage. CAF alone and with various modifications have been used widely and successfully. Studies have stated that SCTG has not only the highest percentage of mean root coverage but also least variability. In spite of its promising results, SCTG has its own limitations, such as lack of graft availability, need for a second surgical site, proximity to palatine neurovascular complex and unesthetic contour at the recipient site. In some cases, harvesting connective tissue may be difficult in the presence of a flat palatal profile or if thickness of masticatory mucosa appears too thin. The additional chair time must also be considered and compared with that needed to perform a CAF alone. But it has been noted in various studies that CAF alone is not as effective as CAF with CTG, which leads to the attempt of finding an alternative to CTG with all the benefits and none of its drawbacks.
Variants such as membranes, biologic modifiers, and allografts have been developed and tested as substitutes for CTG. Collagen matrix(CM), composed of non-crosslinked porcine collagen, is one such substitute. The matrix is intended to support 3D soft tissue regeneration by favouring blood clot stabilization and early vascularization by its excellent tissue integration. It consists of a superficial cell occlusive layer, and a deeper porous layer. The primary importance of CM lies in that it functions almost as well as CTG in procedures for root coverage and those performed to increase the dimensions of keratinized gingiva, at the same time avoiding all the negatives of the latter. The additional advantages of CM is its influence on the healing cascade and reduced scar retraction. Also it leads to increased thickness of keratinized gingiva thus remedying one of the etiolgical factors of gingival recession. The advent of such materials could have a revolutionary impact within the field of periodontics.
But this merits further research and study in this direction to clarify the position of collagen matrices as a substitute for CTG in periodontal plastic surgeries. Therefore the need for this study is to evaluate the efficacy of collagen matrix as a definitive alternative for CTG and if it will be able to supplant CTG as the most effective method to treat gingival recessions.
Tunnel technique in perioplastic surgery was first introduced by Allen in 1994 , and followed by modifications by Zabalegui(1999), Modified Coronally Advanced Tunnel(MCAT), and Microsurgical CAT. All these techniques have shown remarkable success with root coverage. MCAT technique has certain advantages over CAF/ Modified CAF as the vascular supply of the coronally advanced component is not compromised due to avoidance of vertical/ horizontal incisions.
Recently porcine derived bioresorbable collagen matrices have shown predictable outcomes for augmenting keratinzed gingiva, improved wound healing, recession coverage in localized gingival recession and multiple recession coverage.
However there are very few randomized controlled clinical trials in the literature that compare collagen matrix versus CTG in the management of MRTDs. To the best of our knowledge there is only one RCT that compares MCAT+CTG with MCAT+CM in the management of multiple gingival recessions.
Thus aim of this study will be to compare the effectiveness of collagen versus CTG in the management of Millers class I and II multiple gingival recessions. The use of collagen matrix in combination with Modified Coronally Advanced Tunnel as a surgical technique will be compared for recession coverage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| root coverage with collagen matrix | Experimental | Procedure: root coverage with collagen matrixevaluation of root coverage achieved by collagen matrix in conjunction with modified coronally advanced tunnel in patients with multiple gingival recession |
| root coverage with connective tissue graft | Active comparator | Procedure: root coverage with collagen matrixevaluation of root coverage achieved by connective tissue graft in conjunction with modified coronally advanced tunnel in patients with multiple gingival recession |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- • Pregnant or lactating females 8
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 |
|---|---|---|
| root coverage with collagen matrixthe material used is a porcine derived native collagen matrix which serves an alternative to connective tissue graft. the material is 1.5 mm in thickness with a specific tissue surface to allow for cell migration and a fibrous outer layer. it has a resorption time of 6 months. | Procedure or surgery | root coverage with collagen matrix, root coverage with connective tissue graft |
Primary outcome
gingival recession depth
Time frame: 6 months
gingival recession width
Time frame: 6 months
complete root coverage
Time frame: 6 months
clinical attachment level
Time frame: 6 months
keratinized tissue width
Time frame: 6 months
probing depth
Time frame: 6 months
3 secondary outcomes
plaque index
Time frame: 6 months
gingival bleeding index
Time frame: 6 months
gingival index
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 11 Dec 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing root coverage with collagen matrix in people with Gingival Recession, run by Krishnadevaraya College of Dental Sciences & Hospital at 1 site in India.
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 0 inclusion and 8 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 11 Dec 2017. 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 India. 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?
gingival recession depth (time frame: 6 months). The study lists 6 primary outcomes in all. 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 11 Dec 2017.