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Outcome of Regenerative Endodontic Procedure and Root Canal Treatment for the Management of Apical Periodontitis

NCT06179433 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-12-21

No results posted yet for this study

Summary

Background Root canal therapy is the primary treatment of choice for necrotic mature teeth with periapical lesions (PRLs), which does not restore the tooth's vitality. Provided that injectable platelet-rich fibrin (i-PRF) has shown promising results in regenerative medicine as a novel platelet concentration, the purpose of this study is to ascertain whether i-PRF, as opposed to blood clot (BC), can serve as a biological scaffold, thereby expanding the indications for regenerative endodontic procedures (REPs) in mature teeth.

Novelty There is no study available that has evaluated the outcome of REP in the necrotic mature mandibular molars with periapical lesions. Furthermore, the efficacy of novel i-PRF as a scaffold in REPs remains to be explored.

Objectives To evaluate and compare the outcome of REPs in comparison to conventional RCT in necrotic mature molars with PRLs and to evaluate the efficacy of i-PRF and BC in REP as a scaffold. Secondary objective is to evaluate pain for first postoperative week and subjective responses to pulp sensibility tests at 12 months follow-up.

Method 120 patients presenting with necrotic pulp and periapical lesions will be randomly allotted to one of the three groups - REP using i-PRF or BC or RCT group. Comparative evaluation of outcome of REP and RCT will be performed at 12-months follow-up.

Conditions

  • Apical Periodontitis

Interventions

PROCEDURE

Root canal treatment

Two-visit root canal treatment will be performed.

PROCEDURE

Regenerative endodontic procedure

Regenerative endodontic procedure with i-PRF and blood clot induction will be performed.

Sponsors & Collaborators

  • Postgraduate Institute of Dental Sciences Rohtak

    lead OTHER

Principal Investigators

  • jigyasa 1 duhan, MDS · PGIDS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-01
Primary Completion
2024-09-01
Completion
2024-09-01

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06179433 on ClinicalTrials.gov