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

NCT06179433 | Unknown

• 1 other identifier: Dr.Jigyasa Duhan
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

regenerative endodontics, root canal treatment

Outcome Measures

Primary Outcomes (1)

• clinical and radiographic success

  Clinical and radiographic success of REPs in comparison to conventional RCT in necrotic mature molars with PRLs

  12 month follow-up.

Secondary Outcomes (2)

• postoperative pain

  1 week

• Pulp sensibility response

  6 and 12 months

Study Arms (3)

root canal treatment

EXPERIMENTAL

Two-visit root canal treatment will be performed.

Procedure: Root canal treatment

REP with I-PRF

ACTIVE COMPARATOR

The first appointment will be performed similar to the conventional RCT group. in the second appointment, i-PRF will be prepared by collecting venous blood and centrifugate at 700rpm for 3 minutes. i-PRF will be injected into canal followed by a bioceramic material.

Procedure: Regenerative endodontic procedure

REP with blood clot

ACTIVE COMPARATOR

The first appointment will be performed similar to the conventional RCT group. In the second appointment, after anesthetizing with 3% mepivacine, the canals will be re-entered and irrigated well with 17% EDTA. Bleeding will be induced by inserting sterile #25 K-file into the 2-3 mm beyond the apical foramen into periapical tissues.

Procedure: Regenerative endodontic procedure

Interventions

Root canal treatment PROCEDURE

Two-visit root canal treatment will be performed.

root canal treatment

Regenerative endodontic procedure PROCEDURE

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

REP with I-PRF; REP with blood clot

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Consenting healthy adults with age range of 18- 40 years
• Patient presenting with atleast one permanent mandibular molar with necrotic pulp (negative response to sensibility testing by cold and electric pulp test).
• Radiographic evidence of periapical radiolucency of strictly endodontic origin score ≥3 according to the classification of Ørstavik et al (diagnosis of asymptomatic apical periodontitis or chronic apical abscess) with lesion size ≤ 5mm

You may not qualify if:

• Non-restorable teeth or tooth with severe coronal defect where rubber dam isolation is not possible
• Teeth with root fractures or pathological root resorptions
• Teeth with endodontic- periodontal communications
• Patients with generalized chronic periodontitis or periodontal pocket more than 3 mm
• Teeth with previous root canal treatment
• Severe root canal curvatures
• Pregnant or lactating women
• Patients with a history of systemic diseases and/or receiving medications that affect healing or blood coagulation.

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

postgraduate Institute of Dental sciences

Rohtak, Haryana, 124001, India

Location

MeSH Terms

Conditions

Periapical Periodontitis

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Study Officials

• jigyasa 1 duhan, MDS

  PGIDS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: December 21, 2023
• Study Start: May 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: December 21, 2023

Record last verified: 2023-12

Locations

IN (1)