| CTRI Number |
CTRI/2025/06/089780 [Registered on: 27/06/2025] Trial Registered Prospectively |
| Last Modified On: |
13/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Scientific Comparison of Pulp Treatment Materials in Childrens Teeth: Bioactive Glass, MTA Putty, and Biodentine |
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Scientific Title of Study
|
Comparative Evaluation Of Efficacy Of Bioactive Glass, MTA Putty, Biodentine As Pulpotomy Agents In Primary Molars:
A Randomized Control 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 Shradha Akolkar |
| Designation |
Post Graduate Student |
| Affiliation |
Bhararti Vidyapeeth Deemed to be University dental college and hospital |
| Address |
Bhararti Vidyapeeth Deemed to be University dental college and hospital,Pune – Satara Road, Katraj - Ambegaon BK Rd, Dhankawadi, Pune, Maharashtra 411043
Pune
MAHARASHTRA
411043
India |
| Phone |
9515965008 |
| Fax |
|
| Email |
shradhaakolkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Shweta Mayur Chaudhary |
| Designation |
Assistant professor and Post graduate guide |
| Affiliation |
Bhararti Vidyapeeth Deemed to be University dental college and hospital |
| Address |
Department of pediatric and preventive dentistry,Bhararti Vidyapeeth Deemed to be University dental college and hospital,Pune – Satara Road, Katraj - Ambegaon BK Rd, Dhankawadi, Pune, Maharashtra 411043
Pune
MAHARASHTRA
411043
India |
| Phone |
9665113526 |
| Fax |
|
| Email |
shwetadixitchaudhary@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shradha Akolkar |
| Designation |
Post Graduate Student |
| Affiliation |
Bhararti Vidyapeeth Deemed to be University dental college and hospital |
| Address |
Bhararti Vidyapeeth Deemed to be University dental college and hospital,Pune – Satara Road, Katraj - Ambegaon BK Rd, Dhankawadi, Pune, Maharashtra 411043
MAHARASHTRA
411043
India |
| Phone |
9515965008 |
| Fax |
|
| Email |
shradhaakolkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth (Deemed to be University) Dental college and Hospital, Pune, Pune – Satara Road, Katraj - Ambegaon BK Rd, Dhankawadi, Pune, Maharashtra 411043, India |
|
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Primary Sponsor
|
| Name |
Bhararti Vidyapeeth Deemed to be University dental college and hospital |
| Address |
Bhararti Vidyapeeth Deemed to be University dental college and hospital, Pune – Satara Road, Katraj - Ambegaon BK Rd, Dhankawadi, Pune, Maharashtra 411043 |
| Type of Sponsor |
Private medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrShradha Akolkar |
Bharati vidyapeeth(Deemed to be university) dental college and hospital |
Department of Pediatric and Preventive Dentistry, room Number : 208, 2nd floor, dental wing.
Pune
MAHARASHTRA |
9515965008
shradhaakolkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati vidyapeeth (deemed to be unniversity)pune india dental college and hospital , pune instituitional ethics committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy children without any systemic or medical illness aged between 4 to 9 years who have carious primary molars are taken into trial |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1.Biodentine
2.Bioglass |
This study is aimed to check the efficacy of new pulpotomy agents and compare them against standard gold regenerative agent.
Two Intervention agents used bidodentine,bioactive glass.
Biodentine is a calcium silicate-based material developed as a dentin substitute with excellent biocompatibility and bioactivity. It promotes the formation of a dentin bridge and maintains pulp vitality by releasing calcium ions, which stimulate hard tissue regeneration. Biodentine has shown superior sealing ability and a short setting time compared to traditional MTA. Clinical studies have reported high success rates in pulpotomy of primary teeth, demonstrating minimal post-operative inflammation and good long-term outcomes. Its ease of handling and favorable biological response make it a reliable material for vital pulp therapy in pediatric dentistry.
Bioactive Glass (e.g., 45S5 Bioglass) is a biocompatible material known for its ability to bond with hard and soft tissues. When used in pulpotomy, it releases calcium and phosphate ions, forming a hydroxycarbonate apatite layer that supports pulp healing and dentin bridge formation. It has shown anti-inflammatory, antibacterial, and remineralizing properties, making it suitable for pulp therapy. Though less extensively studied than MTA or Biodentine, emerging research supports its effectiveness in maintaining pulp vitality and promoting reparative dentinogenesis. Its regenerative potential and bioactivity position it as a promising material in pediatric endodontics.
|
| Comparator Agent |
MTA putty |
The comparator agent used is MTA PUTTY.
MTA Putty is a premixed, ready-to-use formulation of mineral trioxide aggregate, developed to overcome the handling limitations of conventional MTA. It retains the core advantages of MTA, such as excellent biocompatibility, sealing ability, and the ability to induce hard tissue formation. MTA Putty promotes pulp healing by releasing calcium ions, encouraging the formation of a dentin bridge while maintaining pulp vitality. Studies have shown high clinical and radiographic success rates in primary molar pulpotomies, with reduced setting time and easier application compared to traditional MTA. Due to its predictable outcomes and ease of use, MTA Putty is considered a gold standard material for vital pulp therapy in pediatric dentistry. |
|
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Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
Healthy children between age 4-9 years will be selected for the study
The clinical inclusion criteria selected for the study are as follows:
1. Vital primary molars with probable carious pulp exposure
2. Absence of spontaneous pain or persistent pain or nocturnal pain
3. No clinical symptoms or evidence of chronic irreversible pulpitis.
4. No history of swelling or sinus tracts.
5. Restorable tooth structure should be present
6. Haemorrhage from the amputation site is bright red and easy to control.
Radiographic inclusion criteria were as follows:
1. Radiographic evidence of not more than one-third of physiologic root resorption
2. Absence of furcal and/or periapical radiolucency
3. Absence of radiographic evidence of internal or external root resorption
4. Absence of pathologic root resorption
|
|
| ExclusionCriteria |
| Details |
1. Any clinical or radiographic inclusion criteria are not met
2. Children with systemic disorders or immunocompromised patients.
3. Remaining radicular tissue of the tooth was non-vital (suppuration/purulent necrosis)
4. Evidence of chronic irreversible pulpitis.
5. Haemostasis could not be achieved within 5 minutes by direct contact with a wet cotton pellet, prior to material placement
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Method of Generating Random Sequence
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Coin toss, Lottery, toss of dice, shuffling cards etc |
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Method of Concealment
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Case Record Numbers |
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Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
Primary outcome includes clinical and radiographic assessments at 1, 3, and 6 months. Clinical success: no pain, swelling, tenderness, abscess, fistula, mobility, or early exfoliation. Radiographic success: normal PDL space, no periapical/furcal radiolucency, and no root resorption.
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Time points
Clinical and radiographic outcomes will be carried out at intervals or time points of 1,3,6 months. The clinical examinations will be performed according to criteria of clinical success, and radiographic examinations according to radiological criteria as mentioned in the prior column .
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Secondary Outcome
|
| Outcome |
TimePoints |
1.Pain after the procedure
2.Handling properties of the material
3.Time required to complete the procedure
4.Patient or parent satisfaction
5. Incidence of complications or need for retreatment |
at followup of 1month 3month 6month |
|
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Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/07/2025 |
| 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="0"
Months="8"
Days="0" |
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Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
Pulpotomy in primary dentition is a common therapeutic procedure which involves surgical amputation of the coronal infected portion of the vital pulp followed by the application of a medicament over the residual radicular pulp tissue to promote healing. Successful pulpotomy procedure depends not only on the correct diagnosis of the inflamed dental pulp but also on the selection of an effective and biocompatible medicament. The ideal pulpotomy material should be bactericidal and harmless to cells and surrounding structures promote healing of the pulp tissue and not interfere with the physiologic root resorption Regeneration is a procedure to stimulate dentinal bridge or reparative dentin formation. There are various regenerative agents for pulpotomy such as calcium hydroxide Mineral Trioxide Aggregate MTA bone morphogenic protein enamel matrix derivative lyophilized freeze dried platelet derived proteins and calcium enriched mixture. Mineral Trioxide Aggregate MTA has been a material of revolution in the field of dentistry since its introduction in the 1990s. It is being extensively used for perforation repairs apexification root-end filling obturation tooth fracture repair regenerative procedures apexogenesis pulpotomies and as a pulp-capping material because of its desired features such as biocompatibility bioactivity hydrophilicity sealing ability and low solubility. Even though its application is wide it has its own drawbacks that prevent it from reaching its full potential as a comprehensive replacement material including a long setting time discoloration mud like consistency and poor handling characteristics. MTA Putty is a pre-mixed bio-ceramic insoluble radiopaque and bioactive paste consisting of very fine hydrophilic particles of several mineral oxides. It is Premixed Bio-active cement with perfect consistency for easy placement possesses a nonstickey consistency. The hypothesis is to test the ease of handling of pre mixed MTA putty and if it overcomes the issue of being sandy or gritty as in in original formulation. Biodentine is a calcium silicate cement that can be used for pulpotomy because it is very successful in the formation of a dentine bridge. Biodentine has characteristics similar to natural dentin and enables the stimulation of growth factors that activate dentinogenesis and differentiation of odontoblasts. It has been stated that biodentine has bioactive properties, encourages hard tissue regeneration, and provokes no signs of moderate or severe pulp inflammation response A material is said to be bioactive if it gives an appropriate biologic response and results in the formation of bond between material and the tissue. Bioactive glass is silicate based, containing calcium and phosphate. It is currently regarded as the most biocompatible material in the field of bone regeneration due to its bioactivity osteoconductivity osteoinductivity hemostasis and its antibacterial property Despite the ostensible abilities of bioactive glass to be osteoconductive, osteogenic and dentinogenic little research has been done on their application as pulpotomy agents.The hypothesis is to test whether Bioglass with remineralising properties ,would be successful as pulpotomy agent in primary molars and its comparative evaluation with standard pulpotomy agent MTA, and also Biodentine.
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