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CTRI Number  CTRI/2025/07/089910 [Registered on: 01/07/2025] Trial Registered Prospectively
Last Modified On: 16/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative evaluation of amniotic membrane with and without bioceramic material as pulpotomy agents 
Scientific Title of Study   Quantification of active MMP9 and comparative evaluation of Biodentine with and without Human Amniotic Membrane as pulpotomy agents in mature permanent molars with symptomatic irreversible pulpitis A randomized controlled trial.  
Trial Acronym  None  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Twyla Ferrao 
Designation  Postgraduate student  
Affiliation  Goa Dental College and Hospital 
Address  Department of Conservative Dentistry and Endodontics Goa Dental College and Hospital, Bambolim, Goa 403202 India

North Goa
GOA
403202
India 
Phone  8806240223  
Fax    
Email  tmcf095@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Marina Fernandes 
Designation  Professor 
Affiliation  Goa Dental College and Hospital 
Address  Department of Conservative Dentistry and Endodontics Goa Dental College and Hospital, Bambolim, Goa 403202 India

North Goa
GOA
403202
India 
Phone  9049666453  
Fax    
Email  docrmarina@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Marina Fernandes 
Designation  Professor 
Affiliation  Goa Dental College and Hospital 
Address  Department of Conservative Dentistry and Endodontics Goa Dental College and Hospital, Bambolim, Goa 403202 India

North Goa
GOA
403202
India 
Phone  9049666453  
Fax    
Email  docrmarina@gmail.com  
 
Source of Monetary or Material Support  
None 
 
Primary Sponsor  
Name  Dr Twyla Ferrao 
Address  Department of Conservative Dentistry and Endodontics Goa Dental College and Hospital Bambolim Goa 403202 India  
Type of Sponsor  Other [Self funded ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Twyla Ferrao  Goa Dental College and Hospital  Goa Dental College and Hospital Bambolim Goa 403202 India
North Goa
GOA 		 8806240223

tmcf095@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Goa Dental College and Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Pulpitis 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Biodentine   Coronal Pulpotomy in mandibular molars using Biodentine as pulpotomy agents. Restoration with RMGIC and composite restoration. Outcome will be assessed at 1,3,6 months . 
Intervention  Human amniotic membrane with Biodentine  Coronal Pulpotomy in mandibular molars using Human amniotic membrane with Biodentine as pulpotomy agents. Restoration with RMGIC and composite restoration. Outcome will be assessed at 1,3,6 months . 
 
Inclusion Criteria  
Age From  13.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Clinical diagnosis of SIP without/with periapical rarefaction. (PAI score 1 to 3)
The tooth should give positive response to cold testing.
The tooth is restorable, probing pocket depth and mobility are within normal limits.
No signs of pulpal necrosis including sinus tract or swelling.
Mobility within normal limits.
Radiographically, no evidence of pathological root resorption, and periapical or furcal radiolucency.
 
 
ExclusionCriteria 
Details  Teeth with immature roots
Non restorable teeth
Negative response to cold testing, the presence of sinus tract or swelling
No pulp exposure after caries excavation
Bleeding could not be controlled after full pulpotomy in 10 minutes
Insufficient bleeding after pulp exposure, the pulp is judged necrotic or partially necrotic
Systemic diseases like haemophilia, Von Willebrand disease, platelet abnormalities, and diabetes were excluded.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Patients will be asked to record their pain on a 100mm long visual analogue scale, with 0 representing no pain and 100 representing pain as bad as it could be.

An investigator blinded to the study group instructed all the participants.

 		 24 and 48 hours

 
 
Secondary Outcome  
Outcome  TimePoints 
Clinically, teeth will be evaluated for presence or absence of signs and symptoms associated with any pulpal or periapical disease (spontaneous or persistent pain, discomfort, tenderness on palpation or percussion, sinus, swelling of surrounding tissue), cold and electric pulp testing, periodontal status and the integrity of the restoration.

Radiographically, the assessment will be performed by two calibrated experienced endodontists independently for the evidence of any pathosis like periapical radiolucency (PAI upto 3), furcation involvement or internal/external root resorption. If any disagreement occurs, a consensus will be reached after a mutual discussion.
 		 1, 3, 6 and 12 months  
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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)   15/07/2025 
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="1"
Months="6"
Days="15" 
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  

Patients will be evaluated for inclusion criteria in the study, 36 teeth meeting the inclusion criteria will be included. Patients will be informed of the details of the treatment, and informed consent will be obtained.  


A clinical diagnosis consistent with Symptomatic Irreversible Pulpitis will be established in all cases based on a history of severe spontaneous lingering pain that could be reproduced by cold testing.   After clinical and radiographic examination, the tooth will be anesthetized and,  isolated using a dental dam. The cavity will be prepared using a sterile high-speed diamond bur under water coolant. The exposed pulpal tissue will be amputated up to the orifice. The pulpal blood sample will be collected in a test tube using a micro pipette. The bleeding will be controlled by placing a cotton pellet soaked with NaOCl over the pulpal wound for 2 minutes and repeated for a maximum of 10 minutes. Root canal therapy will be initiated in cases in which hemostasis cannot be achieved.

Once hemostasis is confirmed, the tooth will randomly be allocated to 1 of 2 parallel arms using a predetermined computer-generated randomization. The patients will receive the allocated intervention Group 1 Biodentine or Group 2 Human amniotic membrane and Biodentine. The tooth will be sealed with light cured GIC and will be permanently restored with resin composite and a post operative periapical will be taken. The patients will have clinical and radiographic evaluation after 1, 3, 6 and 12 months.

MMP9 values will be quantified in the pulpal blood sample collected during the pulpotomy with a fluorometric assay kit. 

 
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