Pinhole Surgical Technique for Root Coverage Using PRF
Primary Purpose
Recession, Gingival
Status
Unknown status
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
A-PRF
pinhole surgical technique only
Sponsored by
About this trial
This is an interventional treatment trial for Recession, Gingival
Eligibility Criteria
Inclusion Criteria:
- 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%
Exclusion Criteria:
- 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
Sites / Locations
- Krishnadevaraya college of dental sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
pinhole surgical technique with Platelet Rich Fibrin
pinhole surgical technique only
Arm Description
minimally invasive tunneling procedure followed by coronal advancement with placement of Platelet Rich Fibrin membrane
coronal advancement following minimally invasive tunneling procedure
Outcomes
Primary Outcome Measures
Recession depth reduction
measured as the distance in mm from the CEJ to the gingival margin.
total soft tissue gain
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
Secondary Outcome Measures
mean root coverage
amount of coverage obtained, in percentage
Full Information
NCT ID
NCT04202198
First Posted
December 14, 2019
Last Updated
December 14, 2019
Sponsor
Krishnadevaraya College of Dental Sciences & Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04202198
Brief Title
Pinhole Surgical Technique for Root Coverage Using PRF
Official Title
Comparative Evaluation of Recession Coverage Obtained Using Pinhole Surgical Technique, With and With Out Platelet Rich Fibrin : A Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 22, 2019 (Actual)
Primary Completion Date
September 30, 2020 (Anticipated)
Study Completion Date
November 10, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Krishnadevaraya College of Dental Sciences & Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recession, Gingival
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
pinhole surgical technique with Platelet Rich Fibrin
Arm Type
Experimental
Arm Description
minimally invasive tunneling procedure followed by coronal advancement with placement of Platelet Rich Fibrin membrane
Arm Title
pinhole surgical technique only
Arm Type
Active Comparator
Arm Description
coronal advancement following minimally invasive tunneling procedure
Intervention Type
Biological
Intervention Name(s)
A-PRF
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
pinhole surgical technique only
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recession depth reduction
Description
measured as the distance in mm from the CEJ to the gingival margin.
Time Frame
6 months
Title
total soft tissue gain
Description
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
Time Frame
6 months
Secondary Outcome Measure Information:
Title
mean root coverage
Description
amount of coverage obtained, in percentage
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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%
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Rashmi P, MDS
Organizational Affiliation
Krishnadevaraya college of dental sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Krishnadevaraya college of dental sciences
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
562157
Country
India
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pinhole Surgical Technique for Root Coverage Using PRF
We'll reach out to this number within 24 hrs