Outcome of Regenerative Endodontic Procedure and Root Canal Treatment for the Management of Apical Periodontitis
NCT ID: NCT06179433
Last Updated: 2023-12-21
Study Results
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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ACTIVE_NOT_RECRUITING
NA
40 participants
INTERVENTIONAL
2023-05-01
2024-09-01
Brief Summary
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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.
Detailed Description
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The most common scaffold for revascularization involves creation of blood clot (BC) by inducing bleeding from the periapical tissue using an endodontic file. However, blood clots are a meagre source of growth factors, and the precise method required to control the rate and volume of bleeding is still uncertain (13-15). Second-generation platelet concentrate, or platelet-rich fibrin (PRF), is a type of natural autologous fibrin matrix containing trapped leukocytes and platelets to ensure a sustained release of cytokines and growth factors. However, their applicability is restricted because of its solid nature. The development of a liquid form of PRF (injectable PRF) in 2016 was made possible by the use of gentle or low speed centrifugation, which has benefits for bone, periodontal cartilage, and pulp tissue regeneration (16,17). After application, injectable PRF (i-PRF) gradually changes into a growth factor-rich PRF clot that releases growth factors steadily over the course of 10 to 14 days (16).
To the best of our knowledge, no study has been conducted that utilized i-PRF as a scaffold for REPs in mature teeth. Therefore, the aim of this trial is to evaluate and compare the efficacy of i-PRF and blood clot as scaffolds in REPs in comparison to nonsurgical root canal treatment in necrotic mature molars with periapical lesions (PRLs).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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root canal treatment
Two-visit root canal treatment will be performed.
Root canal treatment
Two-visit root canal treatment will be performed.
REP with I-PRF
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.
Regenerative endodontic procedure
Regenerative endodontic procedure with i-PRF and blood clot induction will be performed.
REP with blood clot
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.
Regenerative endodontic procedure
Regenerative endodontic procedure with i-PRF and blood clot induction will be performed.
Interventions
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Root canal treatment
Two-visit root canal treatment will be performed.
Regenerative endodontic procedure
Regenerative endodontic procedure with i-PRF and blood clot induction will be performed.
Eligibility Criteria
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Inclusion Criteria
2. Patient presenting with atleast one permanent mandibular molar with necrotic pulp (negative response to sensibility testing by cold and electric pulp test).
3. 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
Exclusion Criteria
* 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.
18 Years
40 Years
ALL
Yes
Sponsors
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Postgraduate Institute of Dental Sciences Rohtak
OTHER
Responsible Party
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Principal Investigators
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jigyasa 1 duhan, MDS
Role: PRINCIPAL_INVESTIGATOR
PGIDS
Locations
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postgraduate Institute of Dental sciences
Rohtak, Haryana, India
Countries
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Other Identifiers
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Dr.Jigyasa Duhan
Identifier Type: -
Identifier Source: org_study_id