Biodentine Versus White MTA Pulpotomy

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by University Ghent
Sponsor:
Information provided by (Responsible Party):
University Ghent
ClinicalTrials.gov Identifier:
NCT01733420
First received: November 7, 2012
Last updated: December 18, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Extensive Decay in Primary Molars
Drug: Biodentine pulpotomy
Drug: White MTA pulpotomy
Drug: Tempophore pulpotomy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Clinical and Radiographic Efficacy of Biodentine™ and White Mineral Trioxide Aggregate in Deciduous Molar Pulpotomy - a Randomized Control Trial

Resource links provided by NLM:


Further study details as provided by University Ghent:

Primary Outcome Measures:
  • Clinical successes after pulpotomy. [ Time Frame: at baseline visit ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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 successes after pulpotomy. [ Time Frame: 6 months after pulpotomy. ] [ Designated as safety issue: No ]
    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 successes after pulpotomy. [ Time Frame: 12 months after pulpotomy. ] [ Designated as safety issue: No ]
    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.

  • Radiographic successes after pulpotomy. [ Time Frame: at baseline visit ] [ Designated as safety issue: No ]
    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.

  • Radiographic successes after pulpotomy. [ Time Frame: 6 months after pulpotomy. ] [ Designated as safety issue: No ]
    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.

  • Radiographic successes after pulpotomy. [ Time Frame: 12 months after pulpotomy. ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 75
Study Start Date: October 2011
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   2 Years to 9 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01733420

Contacts
Contact: Luc Martens, PhD, DDS Luc.Martens@ugent.be

Locations
Belgium
Ghent University Hospital Recruiting
Ghent, Belgium, 9000
Contact: Luc Martens, PhD, DDS       Luc.Martens@ugent.be   
Principal Investigator: Luc Martens, PhD, DDS         
Sponsors and Collaborators
University Ghent
Investigators
Principal Investigator: Luc Martens, PhD, DDS University Ghent
  More Information

No publications provided

Responsible Party: University Ghent
ClinicalTrials.gov Identifier: NCT01733420     History of Changes
Other Study ID Numbers: 2011/538
Study First Received: November 7, 2012
Last Updated: December 18, 2012
Health Authority: Belgium: Ethics Committee

Additional relevant MeSH terms:
Pemetrexed
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on July 20, 2014