Extensive Decay in Primary Molars
Conditions
Brief 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.
Interventions
Sponsors
University Ghent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 9 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical successes after pulpotomy. | 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. |
| Clinical success after pulpotomy. | 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. |
| Radiographic successes after pulpotomy. | 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. |
Countries
Belgium
Outcome results
None listed