Effectiveness of Premixed Bioactive Bioceramic MTA (Neo-Putty®) in Pulpotomies Primary Teeth

Study Overview
=================
Brief Summary
-----------------
The objective of this prospective randomized clinical trial is to assess clinically and radiographically, the effect of NeoPutty as a pulp medicament following coronal pulp amputation in human primary molars with carious pulp exposure in comparison to Formocresol (FC).

Official Title
-----------------
Effectiveness of Premixed Bioactive Bioceramic MTA (Neo-Putty®) Versus Formocresol as Dressing Agents in Pulpotomized Primary Molars

Conditions
-----------------
Pulpotomies on Primary Molars

Intervention / Treatment
-----------------
* Other: Neo-Putty® as dressing agents in pulpotomized primary molars


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primary teeth which requires pulpotomy. Exclusion Criteria: not healthy patients, teeth which requires pulpectomy.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 10 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study Group<br>Asymptomatic primary molars with deep carious lesions scheduled for regular treatment. Exposure of a vital pulp due to caries. No clinical or radiographic evidence of pulp degeneration, such as spontaneous pain, excessive bleeding from the root canal, internal root resorption, inter-radicular and/or periapical bone destruction, swelling, or sinus tract. The possibility of proper restoration of the teeth. | Other: Neo-Putty® as dressing agents in pulpotomized primary molars<br>* Following removal of the coronal pulp with a round bur and hemostasis, the pulp stumps in the study group will be covered with Neo-Putty ® according to the manufacturer's instructions. Neo-Putty will be placed in the prepared cavity, and then covered with Vitrebond® and with a reinforced Zinc Oxide-Eugenol (IRM, Bayer-Leverkussen, Germany). In the control group, a cotton pellet moistened with full-strength FC will be placed for 5 minutes on the amputated pulp, after reaching hemostasis. The pulp stumps will be then covered by IRM<br>|
| control group<br>Asymptomatic primary molars with deep carious lesions scheduled for regular treatment. Exposure of a vital pulp due to caries. No clinical or radiographic evidence of pulp degeneration, such as spontaneous pain, excessive bleeding from the root canal, internal root resorption, inter-radicular and/or periapical bone destruction, swelling, or sinus tract. The possibility of proper restoration of the teeth. | Other: Neo-Putty® as dressing agents in pulpotomized primary molars<br>* Following removal of the coronal pulp with a round bur and hemostasis, the pulp stumps in the study group will be covered with Neo-Putty ® according to the manufacturer's instructions. Neo-Putty will be placed in the prepared cavity, and then covered with Vitrebond® and with a reinforced Zinc Oxide-Eugenol (IRM, Bayer-Leverkussen, Germany). In the control group, a cotton pellet moistened with full-strength FC will be placed for 5 minutes on the amputated pulp, after reaching hemostasis. The pulp stumps will be then covered by IRM<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate of the primary molar pulpotomy |  | One year |