Evaluate the Effect of Graft and Membrane on Healing of Apicomarginal Defects

NCT04366700 | Unknown DMC

• 1 other identifier: Dr Sakshi
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare the effect of guided tissue regeneration using a mixture of autograft and PRF covered with a collagen membrane as compared to the membrane alone in the healing of apicomarginal defects. Healing of the lesions will be compared 2 dimensionaly and 3 dimensionaly using CBCT.

Conditions

Apicomarginal Defects

Keywords

apicomarginal defects; autograft; prf; collagen membrane

Outcome Measures

Primary Outcomes (1)

• change from baseline in periapical radiolucency at 12 months

  2 blinded caliberated operators will score the periapical radiolucency at baseline and 12 months by following scoring scores for 2D healing Score1-Complete healing defined by re-establishment of the lamina dura Score 2- Incomplete healing (scar tissue) Score 3- Uncertain healing Score 4- Unsatisfactory healing scores for 3D healing Score1- Complete healing Score 2- Limited healing Score 3- Uncertain healing Score 4- Unsatisfactory healing

  Baseline to 12 months

Secondary Outcomes (1)

• Clinical success

  Baseline to 12 months

Study Arms (2)

Bone replacement substitute and membrane

ACTIVE COMPARATOR

periapical surgery will be done and defect will be filled with a mixture of autograft and prf and over the defect and denuded root surface collagen membrane will be placed before closure of flap

Procedure: Periapical surgery with autograft and collagen membrane

membrane

ACTIVE COMPARATOR

periapical surgery will be done and defect will be filled with blood clot and over the defect and denuded root surface collagen membrane will be placed before closure of flap

Procedure: Periapical surgery with collagen membrane

Interventions

Periapical surgery with autograft and collagen membrane PROCEDURE

periapical surgery will be done and the defects will be filled with a mixture of autograft and prf and will be covered with a collagen membrane

Bone replacement substitute and membrane

Periapical surgery with collagen membrane PROCEDURE

periapical surgery will be done and the defects will be filled with blood clot and covered with a collagen membrane

membrane

Eligibility Criteria

• Age: 16 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients with age 16 years to 55 years
• Periapical defects with periodontal communication.
• Apicomarginal defects with probing depth \> 6mm on mid-buccal and interproximal surfaces

You may not qualify if:

• Presence of buccal bone on flap elevation.
• Fractured /perforated roots.
• smokers.
• pregnant females and lactating mothers

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

Post Graduate Institute of Dental Science

Rohtak, Haryana, 124001, India

Location

MeSH Terms

Interventions

Transplantation, Autologous

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: double
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2020
• First Posted: April 29, 2020
• Study Start: November 1, 2018
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: May 5, 2020

Record last verified: 2020-04

Locations

IN (1)