Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT06179433 |
| Other study ID # |
Dr.Jigyasa Duhan |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2023 |
| Est. completion date |
September 1, 2024 |
Study information
| Verified date |
December 2023 |
| Source |
Postgraduate Institute of Dental Sciences Rohtak |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Regenerative endodontic procedures (REPs) are biologically based procedures used to replace
damaged structures such as dentin and root structures, as well as pulp-dentin complex cells
(4, 5). Majority of studies have focused on treating immature necrotic teeth with the REP
approach in order to preserve root development and regenerate functional pulp tissue (6-9).
REPs have recently been proposed as an alternative approach to treating necrotic mature
permanent teeth with apical periodontitis due to their promising results (10-12). However, it
did face a few challenges, including fewer stem cells, narrower apical foramina for induction
of blood and stem cell migration, and difficulty disinfecting the root completely (11).
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).
