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Comparison of success of new medicament with gold standrard in primary molar pulpotomy - a randomised controlled trial.

Comparison of clinical and radigraphic success of Mineral trioxide aggregate and modified Biodentine in primary molar pulpotomy - a randomised controlled trial. - nil

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/088592
Enrollment
80
Registered
2025-06-11
Start date
Unknown
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K040- Pulpitis Health Condition 2: R00-R99- Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified

Interventions

Intervention1: Bio D Plus Dentine substitute: New dentin subtitute as pulpotomy medicament Control Intervention1: Maarc MTA: Mineral trioxide aggregate as gold standard pulpotomy medicament

Sponsors

Bhavithra
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Children in the age group of 4-9 years, with signs of reversible pulpitis (Sensitivity to sweet foods or drinks, cold, Sharp pain that lasts only a few seconds , No pain when the tooth is tapped, No sensitivity to heat) in primary molars and requiring pulpotomy procedure. 2.Teeth having adequate bone support with at least 2/3rd of intact root length. 3.Children who provide assent, and parents who provide the consent

Exclusion criteria

Exclusion criteria: Intra operative signs of irreversible pulpitis (uncontrolled pulpal bleeding, non vital pulp tissue) Children with special health-care needs

Design outcomes

Primary

MeasureTime frame
Clinical evaluationAbsence of clinical signs1.Negative to percussion 2.Negative to periapical palpation 3.Absence of fistula/sinus tract 4.Absence of mobility 5.Negative to periodontal probing 6.Absence of swelling Timepoint: 3 months 6 months 12 months

Secondary

MeasureTime frame
Radiologic evaluation Periapical health 1. No apical / furcal radiolucency 2. Pathologic resorption Mineralisation activity 1. Presence of radio-opacity under pulp capping material 2. Absence of canal obliteration Internal resorption 1. Lack of internal root resorption Timepoint: 6 months 12 months

Countries

India

Contacts

Public ContactBhavithra

Government Dental college, Kottayam.

suchithraharikesh@yahoo.co.in9847081035

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026