The Clinical and Radiographic Efficacy of Biodentine™ and White Mineral Trioxide Aggregate in Deciduous Molar Pulpotomy - a Randomized Control Trial
Overview
- Phase
- Phase 3
- Intervention
- Biodentine pulpotomy
- Conditions
- Extensive Decay in Primary Molars
- Sponsor
- University Ghent
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Radiographic successes after pulpotomy.
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
A clinical trial to evaluate and compare three different products used for endodontic treatment (taking the infected nerve out of the teeth) of primary teeth.
Null Hypothesis: The new biological products (WMTA and Biodentine) behave as good as the former iodoform product.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients (Children with carious deciduous molars indicated for pulpotomy) belonging to the category of ASA I according to the 'American Society of Anaesthesiologists'.
- •Patients without any known medical history of systemic complications contradicting pulp treatment.
- •Patients are indicated for treatment under general anaesthesia due to polycaries / fear / anxiety / very young age.
- •Written consent is obtained from the parent/guardian after explaining the full details of the treatment procedure and its possible outcomes.
Exclusion Criteria
- Not provided
Arms & Interventions
Biodentine
Pulpotomy using Biodentine as pulpotomy medicine.
Intervention: Biodentine pulpotomy
White Mineral trioxide Aggregate (MTA)
Pulpotomy using white MTA as pulpotomy medicine.
Intervention: White MTA pulpotomy
Tempophore
Pulpotomy using Tempophore as pulpotomy medicine in a control group.
Intervention: Tempophore pulpotomy
Outcomes
Primary Outcomes
Radiographic successes after pulpotomy.
Time Frame: 12 months after pulpotomy.
Radiographic criteria: presence of normal periodontal ligament space, absence of internal or external root resorption, absence of canal calcification, absence of periradicular radiolucency and no loss or break of lamina dura.
Clinical successes after pulpotomy.
Time Frame: 12 months after pulpotomy.
Clinical evaluation and radiography of the tooth is performed. Clinical criteria: abscence of post-operative pain, absence of pain on percussion and palpation, absence of abscess or swelling, absence of sinus tract or fistula and absence of pathologic tooth mobility.
Clinical success after pulpotomy.
Time Frame: 3 months after pulpotomy.
clinical evaluation and radiography of the tooth is performed. Clinical criteria: abscence of post-operative pain, absence of pain on percussion and palpation, absence of abscess or swelling, absence of sinus tract or fistula and absence of pathologic tooth mobility.