Biodentine Versus White MTA Pulpotomy

Study Overview
=================
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.

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

Conditions
-----------------
Extensive Decay in Primary Molars

Intervention / Treatment
-----------------
* Drug: Biodentine pulpotomy
* Drug: White MTA pulpotomy
* Drug: Tempophore pulpotomy


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 9 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

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. |