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CTRI Number  CTRI/2024/06/069087 [Registered on: 18/06/2024] Trial Registered Prospectively
Last Modified On: 08/04/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   comparing pulpotomy as a conservative treatment option over pulpectomy in symptomatic irreversible pulpitis using three different bioceramic materials 
Scientific Title of Study   Comparative Evaluation of Pulpotomy as a Conservative Treatment Option in Symptomatic Irreversible Pulpitis Using Three Different Bioceramic Materials Versus Pulpectomy : A Randomized Clinical Study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Amol Patil 
Designation  Associate Professor 
Affiliation  M.A. Rangoonwala College of Dental Sciences and Research Centre 
Address  M.A. Rangoonwala College of Dental Sciences and Research Centre, Pune, Maharashtra, India.
Department of pedodontics, Room Number 406, M.A. Rangoonwala College of Dental Sciences and Research Centre, Pune, Maharashtra, India.
Pune
MAHARASHTRA
411001
India 
Phone  9561042279  
Fax    
Email  amolpatil2526@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Maryam Bharmal 
Designation  Post Graduate Student 
Affiliation  M.A. Rangoonwala College of Dental Sciences and Research Centre 
Address  M.A. Rangoonwala College of Dental Sciences and Research Centre, Pune, Maharashtra, India.
Department of Pedodontics, Room Number 406, M.A. Rangoonwala College of Dental Sciences and Research Centre, Pune, Maharashtra, India.
Pune
MAHARASHTRA
411001
India 
Phone  09561042279  
Fax    
Email  amolpatil2526@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Amol Patil 
Designation  Associate Professor 
Affiliation  M.A. Rangoonwala College of Dental Sciences and Research Centre 
Address  M.A. Rangoonwala College of Dental Sciences and Research Centre, Pune, Maharashtra, India.
Department of Pedodontics, Room Number 406, M.A. Rangoonwala College of Dental Sciences and Research Centre, Pune, Maharashtra, India.
Pune
MAHARASHTRA
411001
India 
Phone  09561042279  
Fax    
Email  amolpatil2526@gmail.com  
 
Source of Monetary or Material Support  
M.A.Rangoonwala College of Dental Sciences and Research Institute, Pune -411001 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Amol patil  M.A. Rangoonwala Dental College  Department of Pedodontics, Room Number 406.
Pune
MAHARASHTRA 
9561042279

amolpatil2526@gmail.com 
Amol patil  Private Clinic  Nanded City
Pune
MAHARASHTRA 
9561042279

amolpatil2526@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Ethics Committee MCE Society, Azam Campus, Pune -01  Approved 
Ethics Committee MCE Society, Azam Campus, Pune -01  No Objection Certificate 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Dental Caries 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Pulpectomy  o Caries will be excavated using sterile round bur (BR-S46). o Access will be gained in the pulp chamber using sterile round bur o Access cavity will be enlarged with safe end bur (FO-54C). o Barbed broach will be used to remove debris and inflamed/necrotic pulp tissue from the canal. o Irrigation will be done with the help of saline. o Working length is determined using a 10k file and confirmed with a radiograph. o Chemo-mechanical preparation will be done by the files; canals will be irrigated with 2.5 % sodium hypochlorite and saline to disinfect the canals at the same time remove infected dentin from the canal walls. o Canals will be dried with absorbent paper points. o Canals will be obturated using vitapex. o Vitapex will be injected into the canal. o Followed by restoration with RMGIC. o Followed by the tooth will be covered with full coverage restoration  
Intervention  Pulpotomy  o Caries excavation will be done with sterile round bur (BR-S46). o The bur drop will be taken in the roof of the pulp chamber with another sterile round bur (BR-31C).[3] o The extension of the pulp chamber will be done safely using sterile safe end bur (FO-54C).[3] o Followed by removal of the overhanging structure to straighten the dentin walls of the pulp chamber allowing direct access to the pulp tissue.[3] o Spoon excavator will be used to remove the inflamed coronal pulp tissue.[3] o Haemostasis will be attained by applying gentle pressure with a sterile cotton pellet soaked in 2.5% NaOCl for 2 minutes, and repeat up to 4-5 times (totalling 8-10 minutes).[3] o Once the bleeding is arrested, a 3mm layer of bioactive material is placed on top of the pulp stump.[3] o And cavity will be restored using Resin Modified GIC (RMGIC) which will be cured for the 20s. [3] o Followed by a full coverage restoration.[3] total duration of intervention - 1 hour 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  1. Healthy (ASA I and II) co-operative children (Frankl Scale + and ++).
2. Children of age group 4 to 9 years.
3. The pulp of the affected primary tooth must be vital.
4. Participants with symptoms of symptomatic irreversible pulpitis in one of the primary teeth.
5. The affected primary teeth must be restorable with crowns.
6. 2/3rd of the root length should be present.
 
 
ExclusionCriteria 
Details  1. Clinical examination of affected primary teeth reveals signs of pulpal infection (e.g. pathologic tooth mobility, parulis/fistula, or soft tissue swelling)
2. Pre-operative periapical radiograph suggests the presence of furcal radiolucency of more than ½ the furcation to the periapical area.
3. Visual examination of pulp tissue after deroofing reveals signs of necrosis (e.g. avascular/minimally bleeding pulp tissue or yellowish necrotic areas/purulent exudate).
4. Teeth with the pulp chamber exposed to the oral environment.
5. If haemostasis is not achieved within 10 min after application of gentle pressure with sterile cotton soaked in 2.5% sodium hypochlorite.
6. Parents not willing to place full coverage restoration post-pulpotomy.
7. Medically compromised patients.
 
 
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 
This will be performed for postoperative pain after 24 hrs and 1 week using
the Numerical Rating Scale from 0-10 (NRS) from Taha et al;2021).
Clinical failure will be determined (3,6 and 12 months) by the subjective
symptoms as explained by the participants, and objective signs as recorded
during clinical examination including abscess, swelling, sinus tract and
tenderness associated with the tooth.
Radiographic assessment
Post-operative radiographs will be obtained at 3 months, 6 months, and 12
months. 
12 months 
 
Secondary Outcome  
Outcome  TimePoints 
Postoperative sensitivity & pain will be evaluated  1 month 
 
Target Sample Size   Total Sample Size="240"
Sample Size from India="240" 
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)   20/07/2024 
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="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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  

   Dental caries causes gradual weakening of tooth enamel, leading to inflammation of the tooth pulp if left untreated. This persistent infection is a major global health concern, with untreated cavities being widespread, affecting approximately 34.1% of the population worldwide.

   Managing dental decay involves preventing it through primary preventive methods and removing decayed tissue through operative interventions. Preserving the health and vitality of the tooth pulp, preventing complications like abscess formation, and developing minimally invasive biological treatments are key focuses in modern clinical practice.[1,6]

   In cases of irreversible pulpitis, the histological condition of the pulp may not always correlate with the clinical diagnosis. Studies have shown that even in advanced inflammation, only certain areas of the coronal pulp show bacterial invasion, while the underlying pulp remains unaffected. It has also been revealed that after the removal of the infected coronal pulp, the remaining pulp tissue has excellent regenerative capabilities.[5]

   Traditionally, root canal treatment (RCT) has been the recommended approach for irreversibly inflamed pulp following exposure to decay [2]. Although nonsurgical root canal treatment (RCT) has positive results, it also comes with drawbacks such as advanced equipment, higher expenses, and occasionally requiring multiple appointments [3]. The management of irreversible pulpitis has been reevaluated in recent years due to increasing evidence from clinical trials demonstrating positive outcomes of vital pulp therapy (VPT) in such cases. Consequently, professional societies have issued new position statements regarding the treatment of teeth with carious pulp exposure and diagnosed with reversible or irreversible pulpitis (AAE, 2021; Duncan et al., 2019) [3].

     Vital pulp therapy (VPT) is viewed as a simpler and more cost-effective approach compared to traditional methods like pulpectomy and root canal filling. Among VPT methods, pulpotomy and indirect pulp capping have proven to be a more reliable and successful intervention compared to direct pulp capping procedures.[4]

   With advancements in understanding pulp biology and the use of newer materials, the concept of "vital pulp therapy" (VPT) has been revisited, leading to successful outcomes in teeth with carious pulp exposures or pulpitis.[4] 

   Pulpotomy is a surgical procedure where the coronal part of the pulp tissue is removed to protect the radicular part, encouraging the growth of dentin bridge using various materials to cover the remaining pulp tissue, taking advantage of the pulp cells’ ability to form dentin.[6]

  There’s a belief that if a pulpotomy fails, retreatment might be easier compared to a root-filled tooth. Both the European Society of Endodontology (ESE) and the American Association of Endodontists (AAE) now endorse VPT as a viable treatment for symptomatic carious pulp exposure. The ESE’s 2019 position aimed to change clinicians’ mindset, advocating for VPT instead of immediately resorting to root canal treatment (RCT).[2]

(add about the ‘position statement by AAE and ESE about use of VPT’ application of same in prim teeth, for ref AAPD 2024 guidelines. Then a line or two about disinfecting agents in VPT for sym irr pulpitis like NaOCl and recent being laser)

 

    Sodium hypochlorite (NaOCl) is one such agent recognized and recommended for its dual effectiveness as a haemostatic and antibacterial agent in dental procedures. It has been found to have no negative impact on pulp repair, healing, or tertiary dentinogenesis. Studies have examined its use in controlling pulpal haemorrhage during pulpotomy in primary teeth, with current research endorsing its safe application at concentrations between 1% to 5% for vital pulp therapy procedures. [8,9]

      Recent studies show, that Nd: YAG, Er: YAG, CO2, and diode lasers have become popular for pulpotomy due to advantages like improved haemorrhage control, and stimulation of regenerative cells. Among these, diode lasers have the benefit of causing less thermal damage and promoting faster pulpal wound healing because the dental pulp has a high-water content, which enhances the absorption of diode laser wavelengths. Studies have shown diode lasers to be more effective than other treatments for pulpotomy in primary molars.[7] (talk about lasers as a disinfecting agent ONLY and not as a pulpotomy agent)

     Historically, VPT faced challenges due to misconceptions about pulp healing and limited material options. Calcium hydroxide was traditionally used, but its success rate was lower than MTA.[7] A full pulpotomy with haemostasis and coronal pulp coverage using calcium silicate cement (CSCs) can be successful. The AAE’s 2021 position statement also supports direct visualization and achieving haemostasis to assess the suitability of pulpotomy for teeth with symptomatic irreversible pulp, emphasizing the use of CSCs and immediate coronal restoration.[2] 

   MTA is a bioactive substance, that excels in forming apatite and sealing, with high pH, radiopacity, and biocompatibility. Despite its strengths.[7] An alternative material Bio dentine was developed as a dentine substitute; it shows great results with its short setting time and similar biocompatibility to MTA. MTA putty, another calcium silicate-based material, developed using bio-ceramic technology, is designed in pre-mixed injectable form as a clinical substitute for MTA.

It has superior handling, improved colour stability, adaptability, and comparable physical and chemical properties to MTA. Importantly, it releases calcium and phosphate ions necessary for hydroxyapatite deposition.[7]

So, the present study aims to evaluate the success rate of pulpotomy with 3 different CSC in symptomatic irreversible pulpitis in primary teeth as a treatment option.

 

 
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