Biodentine Versus White MTA Pulpotomy

Extensive Decay in Primary Molars Clinical Trial

Official title:

The Clinical and Radiographic Efficacy of Biodentine™ and White Mineral Trioxide Aggregate in Deciduous Molar Pulpotomy - a Randomized Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01733420
• Other study ID #: 2011/538
• Status: Completed
• Phase: Phase 3
• Start date: October 4, 2011
• Est. completion date: February 2016

Study information

• Verified date: November 2021
• Source: University Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 9 Years

Eligibility

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.

Related Conditions & MeSH terms

• Extensive Decay in Primary Molars

Intervention

Drug:
• Biodentine pulpotomy

• White MTA pulpotomy

• Tempophore pulpotomy

Locations

Country	Name	City	State
Belgium	Ghent University Hospital	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical successes 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.	at baseline visit
Primary	Clinical success 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.	3 months after pulpotomy.
Primary	Clinical successes 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.	6 months after pulpotomy.
Primary	Clinical successes 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.	12 months after pulpotomy.
Primary	Radiographic successes 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.	at baseline visit
Primary	Radiographic successes 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.	6 months after pulpotomy.
Primary	Radiographic successes 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.	12 months after pulpotomy.