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

January 6, 2025 updated by: Postgraduate Institute of Dental Sciences Rohtak

"Role of Guided Tissue Regeneration on Healing Outcome & Quality of Life in Combined Endo Perio Lesions With Communication: A Randomized Controlled Trial"

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • India
      • Haryana, India
        • Recruiting
        • PGIDS Rohtak
        • Contact:
        • Contact:
          • SHWETA MITTAL, MDS
          • Phone Number: 9255596960

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pt with apicomarginal defects & interproximal bone loss receiving GTR
Surgery performed using ACM membrane and PRF plug.
Procedure: Endodontic Micro-Surgery
Surgery performed using ACM membrane and PRF plug in test group & without membrane & PRF in control group.
Active Comparator: Pt with apicomarginal defects & interproximal bone loss without GTR
Surgery performed without ACM membrane and PRF plug.
Procedure: Endodontic Micro-Surgery
Surgery performed using ACM membrane and PRF plug in test group & without membrane & PRF in control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Periapical healing assessment
Time Frame: Base line to 12 months
Periapical healing comparison in 2 groups 2D radiographic healing by Rud et al and Molven et al criteria and 3D healing by modified PENN 3D Criteria. Healing will be categorised into complete, incomplete, uncertain, unsaisfactory.
Base line to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life assessment
Time Frame: Base line to 12 months
to assess pain, swelling, mouth opening and effect on daily activities of patient among test and control group using OHIP-14 questionnaire. Pain Assesment with Value 0 indicate no pain & 100 indicate maximum pain.
Base line to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Postgraduate Institute of Dental Sciences Rohtak

Investigators

  • Study Director: Dr, Sanjay Tewari, MDS, PGIDS, Rohtak, Haryana, 124001

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 23, 2024

Primary Completion (Estimated)

December 23, 2025

Study Completion (Estimated)

December 23, 2025

Study Registration Dates

First Submitted

May 22, 2024

First Submitted That Met QC Criteria

October 13, 2024

First Posted (Actual)

October 16, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 6, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Parichay Singhal

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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