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

NCT ID: NCT05171543

Last Updated: 2021-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2022-05-01

Brief Summary

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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.

Detailed Description

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Periapical surgery is a viable treatment option in teeth with persistent apical periodontitis, especially in cases which fail to heal by non surgical treatment. Kim and Kratchman classified periradicular lesions into categories A-F. Lesions A-C are of endodontic origin without any periodontal pockets and vary with respect to the size of periapical radiolucency while D-F are combined endodontic - periodontal origin and are ranked accoding to the magnitude of periodontal breakdown. Type F defects are commonly referred to as apicomarginal defects and have worst prognosis among all. The lower success rate is attributed to the apical migration of junctional epithelium and intrusion of non osteogenic connective tissue into the periapical region.

Various resorbable and non resorbable collagen membrane with or without xenograft, allograft and alloplastic materials have been used in different studies. Although animal studies have reported high success rates with the use of bone graft materials and membranes over the controls but no human study till date has evaluated or compared the effect of using an allograft and membrane versus Control.

Thus, the aim of the present study is to investigate to two hypothesis. The first null hypothesis stated that there would be no difference between quality of life and healing outcome of periapical defects with periodontal communications following surgery using membrane with allograft and the conventional control group utilizing no GTR technique. The second null hypothesis stated that there would be no difference in outcome derived from the assessment of 2D periapical radiographs and 3D CBCT imaging.

Conditions

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Apicomarginal Defects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Periapical surgery with placement of an allograft and a membrane

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.

Group Type EXPERIMENTAL

Periapical surgery with placement of an allograft and a membrane

Intervention Type 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 no placement of any graft or membrane

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Periapical surgery with placement of an allograft and a membrane

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 1\. 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.

Exclusion Criteria

\- 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.

2\. Chronic generalized periodontitis, 3. Evidence of root fracture, 4. resorptive processes involving more than apical third of the root
Minimum Eligible Age

16 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Postgraduate Institute of Dental Sciences Rohtak

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sanjay Tewari

Rohtak, Haryana, India

Site Status RECRUITING

Countries

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India

Facility Contacts

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Sanjay Tewari

Role: primary

Other Identifiers

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Rahul Sharma

Identifier Type: -

Identifier Source: org_study_id