NCT01733420 - Biodentine Versus White MTA Pulpotomy | Crick

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

120

Conditions

Extensive Decay in Primary Molars

Interventions

Biodentine pulpotomyDRUG

White MTA pulpotomyDRUG

Tempophore pulpotomyDRUG

Eligibility

Sex: ALLMin age: 2 YearsMax age: 9 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Ghent University Hospital

Ghent, Belgium

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.