Recession, GingivalPhase 2NCT04202198
Pinhole Surgical Technique for Root Coverage Using PRF
A Phase 2 study testing A-PRF and pinhole surgical technique only in people with Recession, Gingival, run by Krishnadevaraya College of Dental Sciences & Hospital at 1 site in India.
Trial summary
The current study is a prospective randomised split mouth study to evaluate the effect of Platelet Rich Fibrin as an adjunct to the minimally invasive pinhole surgical technique. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Recession, Gingival
- What is being tested?
- A-PRF and pinhole surgical technique only
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIndia
- Study dates
- 22 Nov 2019to 10 Nov 2020
- Phase
- Phase 2
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Two or more teeth having Millers class I, II andIII or combined recession defects.
- Patients with esthetic concerns and willing to participate in the study
- Age between 18-55 years
- Full mouth plaque score < 20%
Who cannot join
- Pregnant or lactating females
- Tobacco smokers
- Uncontrolled medical conditions precluding elective surgery
- Untreated periodontal conditions
- Patients treated with any medication known to cause gingival hyperplasia
- Drug and alcohol abuse
- Teeth with hopeless prognosis
Trial locations and contacts
1 site in 1 country.
India1 site
Krishnadevaraya college of dental sciences
Bangalore, Karnataka, 562157
About this study
Official title: Comparative Evaluation of Recession Coverage Obtained Using Pinhole Surgical Technique, With and With Out Platelet Rich Fibrin : A Randomized Controlled Clinical Trial
The current study is a prospective randomised split mouth study to evaluate the effect of Platelet Rich Fibrin as an adjunct to the minimally invasive pinhole surgical technique.
Read the detailed description
Gingival recession is defined as denudation of the tooth root surface due to the apical movement of the gingiva. The occurrence of gingival recession as a periodontal finding has been estimated to be 78.6%. It is multi-factorial and poses problems from different aspects to the patient.Various etiological factors documented over the years include, (in the decreasing order of frequency) toothbrush trauma, malalignment, local factors, occlusal trauma, high frenum attachment, cervical fillings and crown impingement. Recession levels are also influenced by various other factors such as age, sex, teeth and surfaces of teeth, etc.
Over the years, several authors have presented their views on the etiology, types, treatment modalities and prognosis of gingival recession ranging from the direct lateral sliding flap to the most recent minimally invasive techniques. The1970s saw Harvey and Bernimoulin individually demonstrated the use of coronal advancement of the flap along with the use of grafts with the coronal advancement performed 2 months after the grafting was done on the denuded root surface. Subsequently, over the next 3 decades connective tissue grafts along with coronally advanced flap was established as the gold standard for recession coverage.
Lien-Hui Huang (2005) pioneered the use of blood derivatives in the form of Platelet rich Plasma (PRP) for root coverage but with limited or no substantial improvement over existing techniques. More studies were done on blood derivatives and their efficacy which led to the introduction of the second generation of platelet concentrates, Platelet rich Fibrin, as an alternative. Platelet rich Fibrin was first developed by Choukroun in the year 2001 and has been followed by several studies which have revealed that the slow and sustained release of key growth factors makes it a useful bio-healing material. Comparisons with platelet rich plasma have also proved that, platelet rich fibrin has a better release of growth factors and the presence of leukocytes, which offers quicker and more efficient healing with better regenerative potential.
The recent years have seen newer techniques which are aimed at making it a minimally invasive procedure. One such technique was the pinhole surgical technique given by Chao in the year 2012 which involved a tunnelling procedure along with the usage of a bioresorbable membrane which satisfied the expectations of the trial.6Better outcomes can be achieved with the use patient's own products instead of a foreign graft material. Therefore, the present study compares the effectiveness of Platelet Rich Fibrin as an adjunct to the surgical technique for root coverage
- Conditions
- Recession, Gingival
- Being tested
- A-PRF, pinhole surgical technique only
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A-PRFBiological
local anesthesia was administered followed by placement of a hole in the alveolar mucosa adjacent to mesial most recession tooth. tunneling instruments are used to elevate a full thickness tunnel upto the CEJ sparing the tip of the papilla.previously prepared PRF membranes are placed through the access hole and the flap is advanced. 5-0 polyglycolic acid sutures is used to secure the advanced flap.
pinhole surgical technique onlyProcedure or surgery
local anesthesia was administered followed by placement of a hole in the alveolar mucosa adjacent to mesial most recession tooth. tunneling instruments are used to elevate a full thickness tunnel upto the CEJ sparing the tip of the papilla followed by advancement of the flap. 5-0 polyglycolic acid sutures is used to secure the advanced flap.
| Study group | Role | What they receive |
|---|---|---|
| pinhole surgical technique with Platelet Rich Fibrin | Experimental | minimally invasive tunneling procedure followed by coronal advancement with placement of Platelet Rich Fibrin membrane Receives: Biological: A-PRF |
| pinhole surgical technique only | Active comparator | coronal advancement following minimally invasive tunneling procedure Receives: Procedure: pinhole surgical technique only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recession depth reduction
measured as the distance in mm from the CEJ to the gingival margin.
Measured: 6 months
total soft tissue gain
- Total soft tissue gain (TSTG), measured as the product of gingival recession depth and gingival recession width. measured as the product of gingival recession depth and gingival recession width in square mm
Measured: 6 months
Secondary outcomes (1)
mean root coverage
amount of coverage obtained, in percentage
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 posted17 Dec 2019
- Study start22 Nov 2019
- Primary completion30 Sep 2020 (estimated)
- Study completion10 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recession, GingivalStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Rashmi P, MDS, Principal investigator, Krishnadevaraya college of dental sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04202198
- Sponsor's protocol ID
- 02_D012_91559
- Status last verified
- Dec 2019
- First submitted
- 14 Dec 2019
- Last updated
- 17 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Recession Coverage Obtained Using Pinhole Surgical Technique, With and With Out Platelet Rich Fibrin : A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04202198
- Acronym / sponsor ID
- 02_D012_91559
- Conditions
- Recession, Gingival
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & HospitalUniversity, hospital or other
- Study start
- 22 Nov 2019 (actual)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 10 Nov 2020 (estimated)
- First posted
- 17 Dec 2019 (actual)
- 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 current study is a prospective randomised split mouth study to evaluate the effect of Platelet Rich Fibrin as an adjunct to the minimally invasive pinhole surgical technique.
Detailed description
Gingival recession is defined as denudation of the tooth root surface due to the apical movement of the gingiva. The occurrence of gingival recession as a periodontal finding has been estimated to be 78.6%. It is multi-factorial and poses problems from different aspects to the patient.Various etiological factors documented over the years include, (in the decreasing order of frequency) toothbrush trauma, malalignment, local factors, occlusal trauma, high frenum attachment, cervical fillings and crown impingement. Recession levels are also influenced by various other factors such as age, sex, teeth and surfaces of teeth, etc.
Over the years, several authors have presented their views on the etiology, types, treatment modalities and prognosis of gingival recession ranging from the direct lateral sliding flap to the most recent minimally invasive techniques. The1970s saw Harvey and Bernimoulin individually demonstrated the use of coronal advancement of the flap along with the use of grafts with the coronal advancement performed 2 months after the grafting was done on the denuded root surface. Subsequently, over the next 3 decades connective tissue grafts along with coronally advanced flap was established as the gold standard for recession coverage.
Lien-Hui Huang (2005) pioneered the use of blood derivatives in the form of Platelet rich Plasma (PRP) for root coverage but with limited or no substantial improvement over existing techniques. More studies were done on blood derivatives and their efficacy which led to the introduction of the second generation of platelet concentrates, Platelet rich Fibrin, as an alternative. Platelet rich Fibrin was first developed by Choukroun in the year 2001 and has been followed by several studies which have revealed that the slow and sustained release of key growth factors makes it a useful bio-healing material. Comparisons with platelet rich plasma have also proved that, platelet rich fibrin has a better release of growth factors and the presence of leukocytes, which offers quicker and more efficient healing with better regenerative potential.
The recent years have seen newer techniques which are aimed at making it a minimally invasive procedure. One such technique was the pinhole surgical technique given by Chao in the year 2012 which involved a tunnelling procedure along with the usage of a bioresorbable membrane which satisfied the expectations of the trial.6Better outcomes can be achieved with the use patient's own products instead of a foreign graft material. Therefore, the present study compares the effectiveness of Platelet Rich Fibrin as an adjunct to the surgical technique for root coverage
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pinhole surgical technique with Platelet Rich Fibrin | Experimental | Biological: A-PRFminimally invasive tunneling procedure followed by coronal advancement with placement of Platelet Rich Fibrin membrane |
| pinhole surgical technique only | Active comparator | Procedure: pinhole surgical technique onlycoronal advancement following minimally invasive tunneling procedure |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Two or more teeth having Millers class I, II andIII or combined recession defects.
- Patients with esthetic concerns and willing to participate in the study
- Age between 18-55 years
- Full mouth plaque score < 20%
Key exclusion criteria (7 listed)
- Pregnant or lactating females
- Tobacco smokers
- Uncontrolled medical conditions precluding elective surgery
- Untreated periodontal conditions
- Patients treated with any medication known to cause gingival hyperplasia
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 |
|---|---|---|
| A-PRFlocal anesthesia was administered followed by placement of a hole in the alveolar mucosa adjacent to mesial most recession tooth. tunneling instruments are used to elevate a full thickness tunnel upto the CEJ sparing the tip of the papilla.previously prepared PRF membranes are placed through the access hole and the flap is advanced. 5-0 polyglycolic acid sutures is used to secure the advanced flap. | Biological | pinhole surgical technique with Platelet Rich Fibrin |
| pinhole surgical technique onlylocal anesthesia was administered followed by placement of a hole in the alveolar mucosa adjacent to mesial most recession tooth. tunneling instruments are used to elevate a full thickness tunnel upto the CEJ sparing the tip of the papilla followed by advancement of the flap. 5-0 polyglycolic acid sutures is used to secure the advanced flap. | Procedure or surgery | pinhole surgical technique only |
Primary outcome
Recession depth reduction
Time frame: 6 months
measured as the distance in mm from the CEJ to the gingival margin.
total soft tissue gain
Time frame: 6 months
5. Total soft tissue gain (TSTG), measured as the product of gingival recession depth and gingival recession width. measured as the product of gingival recession depth and gingival recession width in square mm
1 secondary outcome
mean root coverage
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
- Individual participant dataSharing planned: No
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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.
Dr. Rashmi P, MDS principal investigator
Krishnadevaraya college of dental sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing A-PRF and pinhole surgical technique only in people with Recession, Gingival, 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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 17 Dec 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 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Recession depth reduction (time frame: 6 months). The study lists 2 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 17 Dec 2019.