A Scientific Comparison of Pulp Treatment Materials in Childrens Teeth: Bioactive Glass, MTA Putty, and Biodentine

Phase 3

Not yet recruiting

Conditions: Healthy children without any systemic or medical illness aged between 4 to 9 years who have carious primary molars are taken into trial

Registration Number: CTRI/2025/06/089780

Lead Sponsor: Bhararti Vidyapeeth Deemed to be University dental college and hospital

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 42

Inclusion Criteria

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.
No history of swelling or sinus tracts.
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 radiographic evidence of internal or external root resorption 4.
Absence of pathologic root resorption.

Exclusion Criteria

Any clinical or radiographic inclusion criteria are not met 2.
Children with systemic disorders or immunocompromised patients.
Remaining radicular tissue of the tooth was non-vital (suppuration/purulent necrosis) 4.
Evidence of chronic irreversible pulpitis.
Haemostasis could not be achieved within 5 minutes by direct contact with a wet cotton pellet, prior to material placement.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	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 .

Secondary Outcome Measures

Name	Time	Method
1.Pain after the procedure	2.Handling properties of the material

Trial Locations

Locations (1): Bharati vidyapeeth(Deemed to be university) dental college and hospital
🇮🇳
Pune, MAHARASHTRA, India
Bharati vidyapeeth(Deemed to be university) dental college and hospital
🇮🇳Pune, MAHARASHTRA, India
DrShradha Akolkar
Principal investigator
9515965008
shradhaakolkar@gmail.com