| CTRI Number |
CTRI/2026/03/106007 [Registered on: 12/03/2026] Trial Registered Prospectively |
| Last Modified On: |
12/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
“A Study Comparing two materials ( Biodentin and Human Amniotic Membrane)for Treating Infected Developing Back Teeth in Children.” |
|
Scientific Title of Study
|
Comparative Evaluation of Clinical and Radiographic Outcomes between Biodentin and Human Amniotic Membrane in Pulpotomy of developing Mandibular Second Molars with Irreversible Pulpitis: A Randomised Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR VARNA R |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
Govt Dental College, Kozhikode |
| Address |
Room no 63, Dept of conservative dentistry and endodontics, govt dental college, Kozhikode
Plot 28, HARINANDANAM, MEDICAL COLLEGE HOUSING BOARD COLONY, KOZHIKODE
Kozhikode
KERALA
673008
India |
| Phone |
9895673748 |
| Fax |
|
| Email |
varnarajesh25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR VARNA R |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
Govt Dental College, Kozhikode |
| Address |
Room no 63, Dept of conservative dentistry and endodontics, govt dental college, Kozhikode
Plot 28, HARINANDANAM, MEDICAL COLLEGE HOUSING BOARD COLONY, KOZHIKODE
KERALA
673008
India |
| Phone |
9895673748 |
| Fax |
|
| Email |
varnarajesh25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR VARNA R |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
Govt Dental College, Kozhikode |
| Address |
Room no 63, Dept of conservative dentistry and endodontics, govt dental college, Kozhikode
Plot 28, HARINANDANAM, MEDICAL COLLEGE HOUSING BOARD COLONY, KOZHIKODE
KERALA
673008
India |
| Phone |
9895673748 |
| Fax |
|
| Email |
varnarajesh25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt. DENTAL COLLEGE, KOZHIKODE, KERALA, INDIA |
|
|
Primary Sponsor
|
| Name |
DR VARNA R |
| Address |
ASSISTANT PROFESSOR,ROOM NO 63, DEPT OF CONSERVATIVE DENTISTRY, GOVT DENTAL COLLEGE , KOZHIKODE, KERALA , INDIA
PIN 673008 |
| Type of Sponsor |
Other [SELF] |
|
|
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 VARNA R |
GOVT DENTAL COLLEGE, KOZHIKODE |
Room no 63, DEPT OF CONSDRVATIVE DENTISTRY AND ENDODONTICS, KOZHIKODE, KERLA, INDIA. PIN 673008
Kozhikode
KERALA |
9895673748
varnarajesh25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, GDC, KOZHIKODE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K95||Diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Biodentin Pulpotomy |
Pulpotomy will be performed under local anesthesia and rubber dam isolation. After access opening and coronal pulp amputation, hemostasis will be achieved using sterile saline-moistened cotton pellets. Biodentin (Septodont, France) will be mixed according to the manufacturer’s instructions and placed over the radicular pulp stumps. A base of glass ionomer cement will be placed over Biodentin, followed by permanent restoration. Clinical and radiographic evaluation will be performed at 1, 3, and 6 months. |
| Intervention |
Human Amniotic Membrane Pulpotomy |
Pulpotomy will be performed under local anesthesia and rubber dam isolation. Following access opening and removal of coronal pulp tissue, hemostasis will be achieved with sterile saline-moistened cotton pellets. Sterile processed Human Amniotic Membrane will be trimmed to appropriate size and placed directly over the radicular pulp stumps. A base of glass ionomer cement will be placed, followed by permanent restoration. Clinical and radiographic follow-up will be conducted at 1, 3, and 6 months. |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
Participants will include healthy children aged 13–17 years (ASA I/II) with developing permanent second molars showing incomplete root formation and a vital pulp diagnosis suitable for pulpotomy. Teeth must have restorable crowns, no radiographic evidence of periapical or furcal radiolucency, no internal/external resorption, and the radicular pulp must exhibit controlled bleeding within 5 minutes after coronal pulp removal. Only teeth with adequate radiographic visibility and patients/guardians who provide informed consent and are willing to attend follow-up visits will be included.
|
|
| ExclusionCriteria |
| Details |
Teeth will be excluded if they show signs of necrosis, uncontrolled radicular bleeding, irreversible pulpitis with swelling or sinus tract, internal or external resorption, or established periapical pathology. Patients with systemic diseases affecting healing (ASA III/IV), allergies to study materials, inability to return for follow-up, poor cooperation, recent antibiotic/steroid use that may confound outcomes, or teeth with previous pulpal procedures will be excluded. Teeth deemed unrestorable or compromised due to trauma, periodontal disease, or insufficient coronal structure will also be excluded.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Clinical Success of Pulpotomy
Absence of spontaneous pain
No swelling/sinus tract
• Positive vitality tests
|
base line, 1 month, 3 months, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Radiographic Success
Dentin bridge formation
No periapical/furcal pathology
Continued root development/apical closure
|
base line, 1 month, 3 months, 6 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/05/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
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
|
This randomized controlled clinical trial aims to comparatively evaluate the clinical and radiographic outcomes of Biodentin and Human Amniotic Membrane when used as pulpotomy agents in developing permanent mandibular second molars diagnosed with irreversible pulpitis.
Eligible participants will be randomly allocated into two parallel groups in a 1:1 ratio. In Group I, pulpotomy will be performed using Biodentin as the pulp dressing material. In Group II, Human Amniotic Membrane will be placed over the radicular pulp tissue. All procedures will be carried out under standardized clinical protocols.
Participants will be evaluated clinically and radiographically at baseline, 1 month, 3 months, and 6 months. The primary outcome will be clinical and radiographic success at 6 months, defined as absence of pain, swelling, sinus tract, tenderness on percussion, abnormal mobility, and absence of radiographic signs such as periapical or furcal radiolucency, root resorption, or periodontal ligament widening.
The study aims to determine whether Human Amniotic Membrane demonstrates comparable clinical and radiographic success to Biodentin in pulpotomy procedures. |