Effect of Combined Use of an Allograft and Membrane on the Healing Outcome of Apicomarginal Defects

NCT05171543 | Unknown

• 1 other identifier: Rahul Sharma
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Healing of apicomarginal defects using 2 different groups, one being treated with the use of an allograft and a membrane and a control group, will be assessed and compared using 2D and 3D criteria. Also,quality of life will be compared between the two groups.

Conditions

Apicomarginal Defects

Outcome Measures

Primary Outcomes (1)

• Healing of apicomarginal defects.

  Patients will be checked clinically for absence of signs and symptoms. Radiographic 2D assessment will be done by Rud and Molven criteria as follows:- Complete healing- defined by re-establishment of the lamina dura Incomplete healing (scar tissue) Uncertain healing Unsatisfactory healing (failure). 3D healing will be assessed by modified PENN 3D criteria(Schloss et al) as- Complete healing Limited healing Uncertain healing Unsatisfactory healing.

  Baseline to 12 months

Secondary Outcomes (1)

• Assessment of quality of life

  Baseline to day 7 postoperatively

Study Arms (2)

Periapical surgery with placement of an allograft and a membrane

EXPERIMENTAL

Patients will undergo periapical surgery and an allograft and a membrane will be placed inside the bony crypt and over the denuded root surface respectively before closure of the flap.

Procedure: Periapical surgery with placement of an allograft and a membrane

Periapical surgery with no placement of any graft or membrane

NO INTERVENTION

Patients will undergo periapical surgery with no placement of any graft or membrane in the control group.

Interventions

Periapical surgery with placement of an allograft and a membrane PROCEDURE

Periapical surgery will be done followed by placement of an allograft into the defect and a membrane over the defect before closure of the flap.

Periapical surgery with placement of an allograft and a membrane

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \. Age 16 years and older consenting to the surgical procedure as well as agreeing to preoperative and at least 1 follow-up CBCT evaluation after 12 months 2. Noncontributory medical history (American Society of Anesthesiologists class I and II) 3. Patients with a deep narrow pocket with probing depth \>6 mm confined to buccal aspect of the root, 4. Negative response to vitality tests, 5. Radiographic evidence of radiolucency, 6. Failed previous root canal treatment and retreatment at least 1 year previously, 7. Previous surgery with unresolved bony lesion, 8. Recurrent episodes of purulent discharge, and 9. Adequate final restoration with no clinical evidence of coronal leakage.

You may not qualify if:

• \- 1. Patients with medical history with American Society of Anesthesiologists class III to V or Any systemic disease contraindicating oral surgical procedures, potentially affecting the healing process.
• \. Chronic generalized periodontitis, 3. Evidence of root fracture, 4. resorptive processes involving more than apical third of the root

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

Sanjay Tewari

Rohtak, Haryana, 124001, India

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2021
• First Posted: December 29, 2021
• Study Start: February 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: December 29, 2021

Record last verified: 2021-05

Locations

IN (1)