| CTRI Number |
CTRI/2025/03/081947 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
26/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the effect of root canal therapy and regrowth therapy for healing of infection |
|
Scientific Title of Study
|
Comparative Evaluation of Regenerative endodontic procedure and conventional non-surgical endodontic procedure for treatment of necrosed mature permanent teeth with apical periodontitis - A Randomized Control Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashlesha Nageshwar Madankar |
| Designation |
Post Graduate Student |
| Affiliation |
Government Dental College and Hospital, Nagpur |
| Address |
117,department of conservative dentistry and endodontics,govt
dental college and hospital,medical square,medical chowk
Nagpur,Maharastra,India Nagpur
Nagpur MAHARASHTRA 440003 India |
| Phone |
09637531050 |
| Fax |
|
| Email |
madankarashlesha@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sulabha Radke |
| Designation |
Associate Professor |
| Affiliation |
Government Dental College and Hospital, Nagpur |
| Address |
117,department of conservative dentistry and endodontics,govt
dental college and hospital,medical square,medical chowk
Nagpur,Maharastra,India Nagpur
Nagpur MAHARASHTRA 440003 India |
| Phone |
9823262628 |
| Fax |
|
| Email |
sulabharadke@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sulabha Radke |
| Designation |
Associate Professor |
| Affiliation |
Government Dental College and Hospital, Nagpur |
| Address |
117,department of conservative dentistry and endodontics,govt
dental college and hospital,medical square,medical chowk
Nagpur,Maharastra,India Nagpur
Nagpur MAHARASHTRA 440003 India |
| Phone |
9823262628 |
| Fax |
|
| Email |
sulabharadke@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government dental college and hospital, medical square,medical
chowk,nagpur,maharastra,440003 |
|
|
Primary Sponsor
|
| Name |
Dr. Ashlesha Madankar |
| Address |
Department of Conservative Dentistry and Endodontics,Government
Dental College and Hospital, Nagpur |
| Type of Sponsor |
Other [self sponsored] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ashlesha Madankar |
Government Dental College and Hospital |
Room 117, Department
of conservative
dentistry and
endodontics
Nagpur MAHARASHTRA |
09637531050
madankarashlesha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional ethics committee,government dental college and hospital,nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A00-B99||Certain infectious and parasitic diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional non-surgical endodontic procedure |
Conventional root canal obturation technique using gutta percha for treatment of necrosed mature permanent teeth |
| Intervention |
Regenerative endodontic Procedure |
Regenerative endodontic Procedure for treatment of necrosed mature permanent teeth in which blood clot will be induced in the patient after administering local anesthesia followed by placement of collagen plug and biodentin as obturating material in coronal third of root followed by composite resin restoration |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Permanent single rooted teeth with complete root formation are included. Permanent single rooted teeth with diagnosis of mature necrosed teeth with symptomatic apical periodontitis and Permanent single rooted teeth indicated for primary root canal treatment with Periapical Index Score (PAI) of equal to or more than 3 are included
|
|
| ExclusionCriteria |
| Details |
Patients who are medically compromised are excluded.Patients who had taken antibiotics in last 1 month and Pregnant and lactating women are excluded.Immature teeth or teeth with root resorption and Teeth with calcified canals and Patients with generalized chronic periodontitis and Teeth with previous root canal treatment and Teeth with canal curvature more than 25 degree and Periodontal pocket larger than 3 mm are excluded
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in Periapical Index Score radiographically |
1,3,6 and 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| CLINICAL EVALUATION (Presence of vitality, swelling, sinus tract with spontaneous, palpation or percussion pain) |
1,3,6 and 12 months |
|
|
Target Sample Size
|
Total Sample Size="58" Sample Size from India="58"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
10/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/03/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Pulp regeneration continues to receive increasing
research attention. Regenerative endodontic procedures (REPs) have been
associated with revascularization procedures originally proposed more than 50
years ago. Effective
sealing at both the apical and coronal ends of a disinfected root canal
system are the essential requisites of a successful root canal treatment.
Gutta-percha along with a sealer has been the material of choice for
obturating the root canals. The periapex contains a variety of progenitor
cells which may participate in the regeneration of tissues as a response to
injury. Thus, regeneration rather than replacement of tissues with an
artificial substitute is the alternative direction in which endodontics is
progressing. Biodentine
was developed as a new class of dental material, introduced in 2010 by Gilles
and Olivier which could conciliate high mechanical properties with excellent
biocompatibility, as well as a bioactive behavior. Biodentine is a new
tricalcium silicate (Ca3SiO5) based inorganic restorative commercial cement
and advertised as ‘bioactive dentine substitute’. The material is claimed to
possess better physical and biological properties compared to other
tricalcium silicate cements such as mineral trioxide aggregate (MTA) and
Bioaggregate(Bioaggregate). It is used
for crown and root dentin repair treatment, repair of perforations or
resorptions, apexification, root-end fillings and as permanent dentine
substitute in large carious lesions.
|
Thus,
this study compares the non-obturating regenerative endodontic procedure using
biodentine and modified triple antibiotic paste with conventional non-surgical
gutta percha obturation procedure for the treatment of necrosed mature
permanent teeth with apical periodontitis. |