Pinhole Surgical Technique for Root Coverage Using PRF

NCT04202198 | Unknown Phase 2

• 1 other identifier: 02_D012_91559
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Recession, Gingival

Outcome Measures

Primary Outcomes (2)

• Recession depth reduction

  measured as the distance in mm from the CEJ to the gingival margin.

  6 months

• 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 Outcomes (1)

• mean root coverage

  6 months

Study Arms (2)

pinhole surgical technique with Platelet Rich Fibrin

EXPERIMENTAL

minimally invasive tunneling procedure followed by coronal advancement with placement of Platelet Rich Fibrin membrane

Biological: A-PRF

pinhole surgical technique only

ACTIVE COMPARATOR

coronal advancement following minimally invasive tunneling procedure

Procedure: pinhole surgical technique only

Interventions

A-PRF BIOLOGICAL

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 with Platelet Rich Fibrin

pinhole surgical technique only PROCEDURE

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.

pinhole surgical technique only

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Krishnadevaraya College of Dental Sciences & Hospital: lead

Study Sites (1)

Krishnadevaraya college of dental sciences

Bangalore, Karnataka, 562157, India

Location

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Officials

• Dr. Rashmi P, MDS

  Krishnadevaraya college of dental sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2019
• First Posted: December 17, 2019
• Study Start: November 22, 2019
• Primary Completion: September 30, 2020
• Study Completion: November 10, 2020
• Last Updated: December 17, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)