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Completed

NCT Number: NCT01733420

Biodentine Versus White MTA Pulpotomy

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.

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Key information

Conditions

Extensive Decay in Primary Molars

Age range

2 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ghent University Hospital

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Biodentine pulpotomy

Drug

White MTA pulpotomy

Drug

Tempophore pulpotomy

Drug

Primary outcomes

  1. Clinical successes after pulpotomy.

    Time frame: at baseline visit

    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.

  2. 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.

  3. Clinical successes after pulpotomy.

    Time frame: 6 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.

  4. 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.

  5. Radiographic successes after pulpotomy.

    Time frame: at baseline visit

    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. Radiographic successes after pulpotomy.

    Time frame: 6 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2015
Study completion
2016
First posted
Nov 27, 2012
Registry last updated
Nov 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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