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

Apicomarginal Defects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04366700
• Other study ID #: Dr Sakshi
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: September 2020

Study information

• Verified date: April 2020
• Source: Postgraduate Institute of Dental Sciences Rohtak
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: September 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Apicomarginal Defects

Intervention

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
• 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

Locations

Country	Name	City	State
India	Post Graduate Institute of Dental Science	Rohtak	Haryana

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Dental Sciences Rohtak

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Clinical success	Clinical success will be assessed by absence of clinical signs and symptoms	Baseline to 12 months