Role of GTR on Healing Outcome & Quality of Life in Combined Endo Perio Lesions With Communication

NCT ID: NCT06643663

Last Updated: 2025-01-08

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

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-23

Study Completion Date

2025-12-23

Brief Summary

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The recovery of periapical defects linked to periodontal communication frequently yields less satisfactory results. Numerous studies and case reports have highlighted the notable success achieved through the application of guided tissue regeneration techniques. More recently, autologous platelet concentrate plug \& placental membrane have emerged as a treatment option for addressing such lesions. Nevertheless, there has been no study using PRF-Medium with ACM membrane on the healing of aforesaid lesion \& quality of life assessment.

Detailed Description

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RESEARCH QUESTION (PICO) Does the combined application of PRF-Medium plug and ACM membrane lead to superior healing outcomes compared to conventional technique in treating apico-marginal defects with interproximal involvement? AIM \&OBJECTIVES: - AIM To assess whether the combined application of PRF-Medium and ACM membrane leads to improved healing outcomes and enhanced quality of life compared to conventional techniques in patients of apico-marinal defects with interproximal involvement. PRIMARY OBJECTIVE

1. To evaluate the impact of combined application of PRF-Medium and ACM membrane on healing outcomes in cases of apico-marginal defects with interproximal involvement with 2D periapical radiographs \& 3D CBCT imaging. SECONDARY OBJECTIVE
2. To evaluate and compare differences in quality of life of patients after periapical surgery with use of PRF-Medium and ACM membrane in cases of apico-marginal defects with interproximal involvement. PICO P(Population)- Patients with non-vital teeth and persistant chronic suppurative apical periodontitis with apico-marginal defects and interproximal involvement. I(Intervention)-Endodontic surgery followed by placement of PRF-Medium plug and ACM membrane. C(Comparison)-Endodontic surgery without using any plug and membrane. O(Outcome)- Periapical healing after surgery in both groups.

Conditions

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Periapical Diseases Endodontic Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Pt with apicomarginal defects & interproximal bone loss receiving GTR

Surgery performed using ACM membrane and PRF plug.

Group Type EXPERIMENTAL

Endodontic Micro-Surgery

Intervention Type PROCEDURE

Surgery performed using ACM membrane and PRF plug in test group \& without membrane \& PRF in control group.

Pt with apicomarginal defects & interproximal bone loss without GTR

Surgery performed without ACM membrane and PRF plug.

Group Type ACTIVE_COMPARATOR

Endodontic Micro-Surgery

Intervention Type PROCEDURE

Surgery performed using ACM membrane and PRF plug in test group \& without membrane \& PRF in control group.

Interventions

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Endodontic Micro-Surgery

Surgery performed using ACM membrane and PRF plug in test group \& without membrane \& PRF in control group.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Patients of age 16yrs and above.
2. Patients with apico-marginal defects and deep pocket upto apex of tooth.
3. Failed primary root canal treatment.
4. Presence of interproximal bone loss.
5. Negative response to vitality test.
6. ASA-1 or ASA- 2 according to the classification of the American Society of Anesthesiologists)

Exclusion Criteria

1. Presence of vertical root fracture
2. Presence of root perforations
3. ASA-3 or ASA-4 according to the classification of the American Society of Anesthesiologists)
4. Presence of root resorption
5. Combined endodontic-periodontic lesions.
6. Pregnancy
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Postgraduate Institute of Dental Sciences Rohtak

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dr, Sanjay Tewari, MDS

Role: STUDY_DIRECTOR

PGIDS, Rohtak, Haryana, 124001

Locations

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Pgids Rohtak

Haryāna, , India

Site Status RECRUITING

Countries

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India

Central Contacts

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Dr. Shweta Mittal, MDS

Role: CONTACT

9255596960

Dr. Parichay Singhal, MDS

Role: CONTACT

9717710642

Facility Contacts

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PARICHAY SINGHAL, PG STUDENT

Role: primary

9717710642

SHWETA MITTAL, MDS

Role: backup

9255596960

Other Identifiers

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Parichay Singhal

Identifier Type: -

Identifier Source: org_study_id

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