Pinhole Surgical Technique for Root Coverage Using PRF

Recession, Gingival Clinical Trial

Official title:

Comparative Evaluation of Recession Coverage Obtained Using Pinhole Surgical Technique, With and With Out Platelet Rich Fibrin : A Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04202198
• Other study ID #: 02_D012_91559
• Status: Enrolling by invitation
• Phase: Phase 2
• Start date: November 22, 2019
• Est. completion date: November 10, 2020

Study information

• Verified date: December 2019
• Source: Krishnadevaraya College of Dental Sciences & Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: November 10, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Gingival Recession
• Recession, Gingival

Intervention

Biological:
• A-PRF
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.

Procedure:
• pinhole surgical technique only
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.

Locations

Country	Name	City	State
India	Krishnadevaraya college of dental sciences	Bangalore	Karnataka

Sponsors (1)

Lead Sponsor	Collaborator
Krishnadevaraya College of Dental Sciences & Hospital

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recession depth reduction	measured as the distance in mm from the CEJ to the gingival margin.	6 months
Primary	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	6 months
Secondary	mean root coverage	amount of coverage obtained, in percentage	6 months