Biodentine Versus White MTA Pulpotomy

Phase 3

Completed

• Conditions: Extensive Decay in Primary Molars
• Interventions: Drug: White MTA pulpotomy; Drug: Tempophore pulpotomy; Drug: Biodentine pulpotomy

• Registration Number: NCT01733420
• Lead Sponsor: University Ghent

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10-04
• Study First Submitted: 2012-11-07
• Study First Submitted QC: 2012-11-20
• Study First Posted: 2012-11-27
• Primary Completion: 2015-11
• Study Completion: 2016-02
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-19
• Last Update Posted: 2021-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
White Mineral trioxide Aggregate (MTA)	White MTA pulpotomy	Pulpotomy using white MTA as pulpotomy medicine.
Tempophore	Tempophore pulpotomy	Pulpotomy using Tempophore as pulpotomy medicine in a control group.
Biodentine	Biodentine pulpotomy	Pulpotomy using Biodentine as pulpotomy medicine.

Primary Outcome Measures

Name	Time	Method
Radiographic successes after pulpotomy.	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.	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.	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.

Trial Locations

Locations (1)

Ghent University Hospital; 🇧🇪 Ghent, Belgium