Gingival RecessionPhase 3NCT03023995
Coronally Advanced Flap With Connective Tissue Graft and PRF for Recession Coverage
A Phase 3 study testing CAF with Platelet rich fibrin and CAF with connective tissue graft in people with Gingival Recession, run by Dr. D. Y. Patil Dental College & Hospital.
Trial summary
Over the years, numerous surgical techniques such as free autografts and pedicle grafts have been introduced to correct gingival recession defects. Combination grafts with either autografts or allografts, and newer concepts of guided tissue regeneration (GTR), platelet concentrates, etc., were developed more recently… Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Gingival Recession
- What is being tested?
- CAF with Platelet rich fibrin and CAF with connective tissue graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Aug 2016
- Phase
- Phase 3
- 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 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female patients with age group between 20 to 55 years,
- Presence of bilateral Millers Class I or II gingival recession defects,
- Periodontally healthy patients,
- Patient who demonstrate acceptable oral hygiene status prior to surgical procedure,
- Patient with a medium to deep palatal vault (for Control Group only),
- Patients agreed to give informed consent
Who cannot join
- History of prolonged use of antibiotics / steroids /immunosuppressive agents/aspirin/anticoagulants/other medications,
- Pregnant women,
- Smokers,
- History of systemic diseases like hypertension, diabetes, HIV, bone metabolic disorders, radiation therapy, immunosuppressive therapy, cancer, etc.
- Patients with unacceptable oral hygiene,
- Faulty tooth brushing technique,
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- Mal-aligned tooth,
- Cervical abrasion,
- Teeth with prominent roots.
About this study
Over the years, numerous surgical techniques such as free autografts and pedicle grafts have been introduced to correct gingival recession defects. Combination grafts with either autografts or allografts, and newer concepts of guided tissue regeneration (GTR), platelet concentrates, etc., were developed more recently to correct mucogingival defects. The use of PRF in various surgical procedures such as degree II furcations, intrabony defects, sinus floor segmentation during implant placement and on facial plastic surgeries have shown promising results. However to our knowledge, till this study was completed, no studies have been reported with the clinical outcomes of autologous platelet rich fibrin membrane for the treatment of localized gingival recession defects.
Hence, this study was designed to compare coronally advanced flap with platelet rich fibrin membrane versus subepithelial connective tissue graft in treatment of Miller's Class I and Class II gingival recession defects.
Read the detailed description
The study design consist of twenty sites from ten patients were randomly selected by tossing the coin for the study, which are divided into test group( Root coverage was performed by coronally advanced flap with platelet rich fibrin membrane) and Control group (Root coverage was performed with coronal advanced flap with subepithelial connective tissue graft.)
The Surgical Procedure consist of i) Preparation of the recipient bed: After adequate anesthesia, trapezoidal flap was designed using three incisions which is followed by reflection of partial thickness flap was raised apical to the crest of the osseous dehiscence. A periosteal releasing incision was given to enable the coronal advancement of the flap. Following this, root planing was done and the mesial and distal interdental papillae were deepithelialized.
The exposed root surface was conditioned with tetracycline hydrochloride for four mins. (The tetracycline hydrochloride powder was mixed with saline in dappen dish and then applied on the root surface).
In test group, preparation of PRF was carried out, after which the flap was coronally positioned over the membrane to completely cover it and secured with non resorbable sutures. The surgical area was covered with a non - eugenol periodontal dressing with post-operative antibiotics and analgesics and post-operative instructions that were given to all the patients.
In control group, connective tissue graft harvesting was carried out which was followed by placement of connective tissue graft on the recipient site. The connective tissue graft was placed on the recipient site and secured in position with vicryl sutures. The flap was coronally positioned over the connective tissue graft and secured with non resorbable sutures. The recipient bed was covered with a non-eugenol periodontal dressing with post-operative antibiotics and analgesics and post- operative instructions that were given to all the patients.
- Conditions
- Gingival Recession
- Being tested
- CAF with Platelet rich fibrin, CAF with connective tissue graft
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAF with Platelet rich fibrinProcedure or surgery
In test group, preparation of PRF was carried out, after which the flap was coronally positioned over the membrane to completely cover it and secured with 4-0 non resorbable sutures.
CAF with connective tissue graftProcedure or surgery
In control group, connective tissue graft was harvested, after which the flap was coronally positioned over the graft to completely cover it and secured with 4-0 non resorbable.
| Study group | Role | What they receive |
|---|---|---|
| CAF with Platelet Rich Fibrin | Experimental | In test group, preparation of PRF was carried out, after which the flap was coronally positioned over the membrane to completely cover it. Receives: Procedure: CAF with Platelet rich fibrin |
| CAF with connective tissue graft | Active comparator | In control group, connective tissue graft harvesting was carried out which was followed by placement of connective tissue graft on the recipient site. The connective tissue graft was placed on the recipient site and secured in position with 5-0 vicryl sutures Receives: Procedure: CAF with connective tissue graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in recession depth
Recession depth reduction from baseline to 6 months
Measured: Baseline to 6 months
Secondary outcomes (4)
Reduction in Mean plaque scores
Mean plaque score reduction form baseline to 6 months
Measured: baseline to 6 months
Reduction in mean gingival scores
Mean gingival score reduction from baseline to 6 months
Measured: Baseline to 6 months
Width of keratinised tissue
Mean keratinised tissue increase from baseline to 6 months
Measured: baseline to 6 months
Change Relative attachment level
Gain in relative attachment level from baseline to 6 months
Measured: baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2017 (estimated)
- Study startAug 2015
- Primary completionAug 2016
- Study completionAug 2016
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. D. Y. Patil Dental College & Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Santosh Martande, Dr. D. Y. Patil Dental College & Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03023995
- Sponsor's protocol ID
- DYP/2010/2PE
- Status last verified
- Jan 2017
- First submitted
- 11 Jan 2017
- Last updated
- 18 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronally Advanced Flap With Connective Tissue Graft and PRF for Recession Coverage
- ClinicalTrials.gov ID
- NCT03023995
- Acronym / sponsor ID
- DYP/2010/2PE
- Conditions
- Gingival Recession
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Dr. D. Y. Patil Dental College & HospitalUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 18 Jan 2017 (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.
Over the years, numerous surgical techniques such as free autografts and pedicle grafts have been introduced to correct gingival recession defects. Combination grafts with either autografts or allografts, and newer concepts of guided tissue regeneration (GTR), platelet concentrates, etc., were developed more recently to correct mucogingival defects. The use of PRF in various surgical procedures such as degree II furcations, intrabony defects, sinus floor segmentation during implant placement and on facial plastic surgeries have shown promising results. However to our knowledge, till this study was completed, no studies have been reported with the clinical outcomes of autologous platelet rich fibrin membrane for the treatment of localized gingival recession defects.
Hence, this study was designed to compare coronally advanced flap with platelet rich fibrin membrane versus subepithelial connective tissue graft in treatment of Miller's Class I and Class II gingival recession defects.
Detailed description
The study design consist of twenty sites from ten patients were randomly selected by tossing the coin for the study, which are divided into test group( Root coverage was performed by coronally advanced flap with platelet rich fibrin membrane) and Control group (Root coverage was performed with coronal advanced flap with subepithelial connective tissue graft.)
The Surgical Procedure consist of i) Preparation of the recipient bed: After adequate anesthesia, trapezoidal flap was designed using three incisions which is followed by reflection of partial thickness flap was raised apical to the crest of the osseous dehiscence. A periosteal releasing incision was given to enable the coronal advancement of the flap. Following this, root planing was done and the mesial and distal interdental papillae were deepithelialized.
The exposed root surface was conditioned with tetracycline hydrochloride for four mins. (The tetracycline hydrochloride powder was mixed with saline in dappen dish and then applied on the root surface).
In test group, preparation of PRF was carried out, after which the flap was coronally positioned over the membrane to completely cover it and secured with non resorbable sutures. The surgical area was covered with a non - eugenol periodontal dressing with post-operative antibiotics and analgesics and post-operative instructions that were given to all the patients.
In control group, connective tissue graft harvesting was carried out which was followed by placement of connective tissue graft on the recipient site. The connective tissue graft was placed on the recipient site and secured in position with vicryl sutures. The flap was coronally positioned over the connective tissue graft and secured with non resorbable sutures. The recipient bed was covered with a non-eugenol periodontal dressing with post-operative antibiotics and analgesics and post- operative instructions that were given to all the patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAF with Platelet Rich Fibrin | Experimental | Procedure: CAF with Platelet rich fibrinIn test group, preparation of PRF was carried out, after which the flap was coronally positioned over the membrane to completely cover it. |
| CAF with connective tissue graft | Active comparator | Procedure: CAF with connective tissue graftIn control group, connective tissue graft harvesting was carried out which was followed by placement of connective tissue graft on the recipient site. The connective tissue graft was placed on the recipient site and secured in position with 5-0 vicryl sutures |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male and female patients with age group between 20 to 55 years,
- Presence of bilateral Millers Class I or II gingival recession defects,
- Periodontally healthy patients,
- Patient who demonstrate acceptable oral hygiene status prior to surgical procedure,
- Patient with a medium to deep palatal vault (for Control Group only),
Key exclusion criteria (9 listed)
- History of prolonged use of antibiotics / steroids /immunosuppressive agents/aspirin/anticoagulants/other medications,
- Pregnant women,
- Smokers,
- History of systemic diseases like hypertension, diabetes, HIV, bone metabolic disorders, radiation therapy, immunosuppressive therapy, cancer, etc.
- Patients with unacceptable oral hygiene,
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 |
|---|---|---|
| CAF with Platelet rich fibrinIn test group, preparation of PRF was carried out, after which the flap was coronally positioned over the membrane to completely cover it and secured with 4-0 non resorbable sutures. | Procedure or surgery | CAF with Platelet Rich Fibrin |
| CAF with connective tissue graftIn control group, connective tissue graft was harvested, after which the flap was coronally positioned over the graft to completely cover it and secured with 4-0 non resorbable. | Procedure or surgery | CAF with connective tissue graft |
Primary outcome
Reduction in recession depth
Time frame: Baseline to 6 months
Recession depth reduction from baseline to 6 months
4 secondary outcomes
Reduction in Mean plaque scores
Time frame: baseline to 6 months
Reduction in mean gingival scores
Time frame: Baseline to 6 months
Width of keratinised tissue
Time frame: baseline to 6 months
Change Relative attachment level
Time frame: baseline to 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 Jan 2017.
- Individual participant dataSharing planned: No
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Evaluation of the Effect of Smoking on Palatal Donor Site Tissue Profile in the Success of Connective Tissue Grafts
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CAF with Platelet rich fibrin and CAF with connective tissue graft in people with Gingival Recession, run by Dr. D. Y. Patil Dental College & Hospital.
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 6 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 18 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Reduction in recession depth (time frame: Baseline to 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 Jan 2017.