Clinical trial NCT04202198: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Recession, Gingival
Lead sponsor: Krishnadevaraya College of Dental Sciences & Hospital
Sponsor class: OTHER
First posted: 2019-12-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Recession depth reduction
timeFrame: 6 months
measure: total soft tissue gain
timeFrame: 6 months
Secondary outcomes:
measure: mean root coverage
timeFrame: 6 months
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Krishnadevaraya college of dental sciences
state: Karnataka
Study officials:
affiliation: Krishnadevaraya college of dental sciences
name: Dr. Rashmi P, MDS
role: PRINCIPAL_INVESTIGATOR
References: