Biodentine Versus White MTA Pulpotomy

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

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.

Study Overview

• Status: Completed
• Conditions: Extensive Decay in Primary Molars
• Intervention / Treatment: Drug: Biodentine pulpotomy; Drug: White MTA pulpotomy; Drug: Tempophore pulpotomy

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • Ghent University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 9 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Biodentine; Pulpotomy using Biodentine as pulpotomy medicine.	Drug: Biodentine pulpotomy
Active Comparator: White Mineral trioxide Aggregate (MTA); Pulpotomy using white MTA as pulpotomy medicine.	Drug: White MTA pulpotomy
Active Comparator: Tempophore; Pulpotomy using Tempophore as pulpotomy medicine in a control group.	Drug: Tempophore pulpotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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.
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.
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.
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
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.
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.

Collaborators and Investigators

• Sponsor: University Ghent
• Investigators: Principal Investigator: Luc Martens, PhD, DDS, University Ghent

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2011
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: November 7, 2012
• First Submitted That Met QC Criteria: November 20, 2012
• First Posted (Estimate): November 27, 2012

Study Record Updates

• Last Update Posted (Actual): November 22, 2021
• Last Update Submitted That Met QC Criteria: November 19, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 2011/538