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

Evaluate the Effect of Graft and Membrane on Healing of Apicomarginal Defects: A Randomized Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Apicomarginal Defects
• Intervention / Treatment: Procedure: Periapical surgery with autograft and collagen membrane; Procedure: Periapical surgery with collagen membrane

Detailed Description

Patients with apicomarginal defects as per the inclusion criteria will be randomly divided into two groups -in test group 1 -the defects will be filled with a mixture of autograft(which will be obtained from the surrounding buccal cortical plate by using a trephine bur) and prf(will be prepared by Choukron's method) and the defects and denuded root surface will be covered with a collagen membrane and in test group 2 -the defects will be filled with a blood clot and over that the collagen membrane will be placed. Radiographic and clinical healing will be assessed after 12 months, 2D healing will be assessed by Rud and Molven criteria and 3D healing will be assessed by Modified Penn 3D criteria.The clinical parameters recorded including periodontal pocket depth (PD), clinical attachment level (CAL) and gingival margin position (GMP) and will be measured on buccal aspect of the interproximal space and mid buccal aspect of the involved teeth using Williams 'O' periodontal probe.Routine examination procedure will be used to evaluate any evidence of signs and/or symptoms.. The criteria for a successful outcome included the absence of clinical signs and/or symptoms and radiographic evidence of complete or incomplete healing.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Haryana
    • Rohtak, Haryana, India, 124001
      • Post Graduate Institute of Dental Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 55 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion criteria

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bone replacement substitute and membrane; 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; 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
Active Comparator: membrane; 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; periapical surgery will be done and the defects will be filled with blood clot and covered with a collagen membrane

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical success	Clinical success will be assessed by absence of clinical signs and symptoms	Baseline to 12 months

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Dental Sciences Rohtak

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Anticipated): September 1, 2020
• Study Completion (Anticipated): September 1, 2020

Study Registration Dates

• First Submitted: April 20, 2020
• First Submitted That Met QC Criteria: April 24, 2020
• First Posted (Actual): April 29, 2020

Study Record Updates

• Last Update Posted (Actual): May 5, 2020
• Last Update Submitted That Met QC Criteria: May 1, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: collagen membrane; autograft; apicomarginal defects; prf
• Other Study ID Numbers: Dr Sakshi

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No