1. What data in particular will be shared?
   Response - All of the individual participant data collected during the trial, after de-identification.
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response - Informed Consent Form
   
   
3. Who will be able to view these files?
   Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
   


4. For what types of analyses will this data be available?
   Response - For individual participant data meta-analysis.
   


5. By what mechanism will data be made available?
   Response (Others) -  email to tpremlatadevi@yahoo.com


6. For how long will this data be available start date provided 01-03-2022 and end date provided 01-08-2023?
   Response - Beginning 3 months and ending 5 years following article publication.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

The goal of restorative therapy is not only to restore the tooth to proper form and function but also to preserve    the pulp vitality. Direct pulp capping helps to seal the pulp against bacterial penetration, encourage the pulp to wall of the exposure by forming a dentine bridge and to maintain healthy pulp tissue. Emdogain serves as a biologically active pulp capping agent specifically inducing pulpal repair and hard tissue formation. Several case reports and clinical studies have evaluated the effect of Biodentine, Emdogain and MTA for pulp capping, but till now histologic studies have not  been conducted and hence this study is planned.

Objectives of the study: 

1.     To evaluate histologically the response of dental pulp to Biodentine as direct pulp capping agent

2.     To evaluate histologically the response of dental pulp to Enamel Matrix Derivative (Emdogain) as direct pulp capping agent

3.     To evaluate histologically the response of dental pulp to Mineral Trioxide Aggregate (MTA) as direct pulp capping agent

4.     To compare the above three

Participants:

Sample Size: 78 subjects

Sampling/Recruitment/Collection: Patients visiting the outpatient department of Conservative Dentistry and         Endodontics, Dental College, RIMS, Imphal

Histologic outcome variables will be measured according to criteria given by Cox et al.

Inflammatory cell response:

Grade 1: Absent or very few inflammatory cells

Grade 2: Mild or average number < 10 inflammatory cells

Grade3: Severe inflammatory lesion appearing as an abscess or dense infiltrate involving one –third or more of the coronal pulp.

Grade 4:  Completely necrotic pulp.

Dentine bridge formation:

Grade 1: Presence of a calcific bridge directly adjacent to some portion of the medicament interface.

Grade 2: Presence of a calcific bridge distant from the medicament interface.

Grade 3: No evidence of any calcific bridge formation in any sections.

Risks involved in the study: No risks and discomfort to the subjects since the teeth are already planned to be extracted for orthodontic/ periodontal treatment and the involved materials are approved by the regulatory authorities and used in routine clinical procedures.

Benefits of the study: In spite of a wide research made in the field of pulp physiology, there is no single gold standard regimen for Direct pulp capping that can achieve reliable and predictable goals of preserving tooth vitality. Preservation of pulp is extremely important to continue growth in root length and width in those teeth in which root formation has not yet been completed, to allow odontoblasts to create a dentine bridge between the pulp and the dressing material, and to maintain pulp function. The benefits of preserving tooth vitality is to maintain tooth function within the oral cavity which allows jaws to maintain a healthy level of bone.

Steps taken up to maintain confidentiality: 

The data acquisition will be coded and not identified by name.