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CTRI Number  CTRI/2025/09/095006 [Registered on: 17/09/2025] Trial Registered Prospectively
Last Modified On: 25/04/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Biological
Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   comparing two innovative treatments to save adult molars with severe tooth pain. 
Scientific Title of Study   Outcome of pulpotomy with human amniotic membrane compared to platelet rich fibrin in mature human permanent molars with symptomatic irreversible pulpitis :a randomized 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  Adhya shyam 
Designation  PG Resident 
Affiliation  Government Dental College Thiruvananthapuram 
Address  Naduvalappil house,Chettiparambu Irinjalakuda Thrissur Kerala
Room no :A252 Department of Conservative Dentistry and Endodontics Government dental college Thiruvananthapuram
Thrissur
KERALA
680121
India 
Phone  8921913705  
Fax    
Email  adhyashyam@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Shiji Dinakaran 
Designation  Professor and Head of Department  
Affiliation  Government Dental College Thiruvananthapuram 
Address  Chathayam T C 13/12 Pettah P.O Thiruvananthapuram 24
Room no :A252 Department of Conservative Dentistry and Endodontics Government dental college Thiruvananthapuram
Thiruvananthapuram
KERALA
695024
India 
Phone  9895402488  
Fax    
Email  shijidinakaran@gmail.com  
 
Details of Contact Person
Public Query  
Name  Adhya shyam 
Designation  PG Resident 
Affiliation  Government Dental College Thiruvananthapuram 
Address  Naduvalappil house,Chettiparambu Irinjalakuda Thrissur Kerala
Room no :A252 Department of Conservative Dentistry and Endodontics Government dental college Thiruvananthapuram
Thrissur
KERALA
680121
India 
Phone  8921913705  
Fax    
Email  adhyashyam@gmail.com  
 
Source of Monetary or Material Support  
Government Dental College,Thiruvananthapuram near Government medical college Thiruvananthapuram pin 695011 Thiruvananthapuram Kerala India 
 
Primary Sponsor  
Name  Adhya Shyam 
Address  Naduvalappil house Chettiparambu Irinjalakuda Thrissur Kerala pin 680121 Thrissur Kerala India contact 8921913705 
Type of Sponsor  Other [self] 
 
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 Adhya Shyam  Government Dental college Thiruvananthapuram  Room no A 252 Dept of Conservative Dentistry and Endodontics Government Dental College Thiruvananthapuram
Thiruvananthapuram
KERALA 		 8921913705

adhyashyam@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE,GOVERNMENT DENTAL COLLEGE,THIRUVANANTHAPURAM  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K040||Pulpitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Pulpotomy with human amniotic membrane  The human amniotic membrane (2 × 2 cm) freeze dried ,which is commercially available from Tata Memorial Hospital, Mumbai will be purchased.The hAM will be stored in room temperature inside portable UV sanitizer( VEND IGO TM,HINDLAB) . The caries will be removed initially with a sterile round diamond bur (Br 31; Mani Inc, Utsunomiya, Japan) at high speed, followed by a sterile low speed carbide round bur (No # 4 andNo # 6 (SSWhite, Lakewood, NJ), on nearing the pulp. Access opening will be done with No # 4 and No # 6 . Haemorrhage will be controlled using a cotton pellet soaked with 2.5% sodium hypochlorite for 10 minutes. From the hAM (2 × 2 cm) freeze dried [ Tata Memorial Hospital, Mumbai],a small piece of size 4×4mm² will be cut using sterile scissors, slightly moistened with saline, and placed. Biodentine will be mixed according to the manufacturer’s instructions and placed over the exposed pulpal tissue using an amalgam carrier and gently packed using a condenser to a thickness of 2 mm. A thin layer of RMGIC will be placed over the material and light cured for 20 seconds. Composite restoration will be placed in the same visit. Postoperative instructions to avoid intake of food or fluid for half an hour and to avoid chewing from the involved side for 24 hours will be given. Analgesics will be prescribed. The patient will be kept on follow- up at 3,6, and 12 months following the procedure and asked to report any occurring discomfort/symptom.  
Comparator Agent  Pulpotomy with platelet rich fibrin  The caries will be removed initially with a sterile round diamond bur (Br 31; Mani Inc, Utsunomiya, Japan) at high speed, followed by a sterile low speed carbide round bur (No # 4 andNo # 6 (SSWhite, Lakewood, NJ), on nearing the pulp. Access opening will be done with No # 4 and No # 6 . Haemorrhage will be controlled using a cotton pellet soaked with 2.5% sodium hypochlorite for 10 minutes. PRF preparation should start at the time of starting caries excavation. PRF will be prepared according to Choukrouns technique.PRF will be obtained by drawing 10 mL of blood from the patient’s antecubital vein and then centrifuged (Choukroun PRF Duo Quattro System) for 12 min under 2700 rpm. The resultant product consisted of the following three layers: Acellular platelet poor plasma at the top of the tube, fibrin clot PRF in the middle of the tube and red blood corpuscles at the bottom of the tube. Due to the absence of an anticoagulant, blood begins to coagulate as soon as it comes in contact with the glass surface. Hence, rapid blood collection and immediate centrifugation, before the clotting cascade gets initiated, are absolutely essential. PRF will be obtained in the form of a membrane by squeezing the fibrin clot in a PRF box (Waldent K40/1).PRF of size 4×4 mm² placed over the amputed pulp. Biodentine will be mixed according to the manufacturer’s instructions and placed over the PRF membrane using an amalgam carrier and gently packed using a condenser to a thickness of 2 mm. A thin layer of RMGIC will be placed over the material nd light cured for 20 seconds. Composite restoration will be placed in the same visit. Postoperative instructions to avoid intake of food or fluid for half an hour and to avoid chewing from the involved side for 24 hours will be given. Analgesics will be prescribed. The patient will be kept on follow- up at 3,6, and 12 months following the procedure and asked to report any occurring discomfort/symptom.  
 
Inclusion Criteria  
Age From  13.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Permanent molars with symptomatic irreversible pulpitis having spontaneous/lingering/night pain.
Patients above 13 years.
Patients and parents of patients below the age of 18 years willing to give assent and informed consent and respectively. 
 
ExclusionCriteria 
Details  Teeth with clinical signs or symptoms indicating pulp degeneration including swelling, sinus tract, tooth mobility and tenderness to percussion
Teeth with periapical lesion ,crestal bone loss, subgingival carious lesions, internal/external resorption, calcified canals
Patients with uncontrolled systemic disease

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the outcome of pulpotomy using human amniotic membrane and platelet rich fibrin as pulpotomy agent in mature human permanent molars with irreversible pulpitis assessed by clinical criteria at 3, 6 and 12 months and radiographic criteria at 6 and12 months follow up.

 		 To compare the outcome of pulpotomy using human amniotic membrane and platelet rich fibrin as pulpotomy agent in mature human permanent molars with irreversible pulpitis assessed by clinical criteria at 3, 6 and 12 months and radiographic criteria at 6 and12 months follow up.

 
 
Secondary Outcome  
Outcome  TimePoints 
Clinical assessment of post operative sensitivity, visible coronal discoloration, radiographically visible dentin bridge formation,diffuse canal calcifications assessed as present or absent.  clinical
criteria at 3, 6 and 12 months and radiographic criteria at 6 and12 months follow up. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   N/A 
Date of First Enrollment (India)   01/10/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/10/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 29-04-2025 and end date provided 29-04-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   Usage of biological scaffold in pulpotomy procedure can enhance the regenerative potential of pulp and thereby preserve vitality of tooth without any toxic effects of overlying restorative material. Here platelet rich fibrin and human amniotic membrane are used as pulpotomy agents  in treating symptomatic irreversible pulpitis .The outcome of this procedure is assessed using ESE Guidelines 2019. 
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