Human Pulpal Response After Pulp Capping With Four Different Agents

Study Overview
=================
Brief Summary
-----------------
Application of four different pulp capping methods on human sound premolars after intentional exposure of the buccal pulp horn through a class one occlusal cavity.

Detailed Description
-----------------
The purpose of this clinical trial is to compare the effect of different direct pulp capping methods on human pulpal response in the terms of inflammation & dentinal bridge formation. Methods: Eight patients providing 32 sound first premolars are selected. As recommended by ISO / TC 7405 pulpal exposure will be performed through a class I cavity. Four groups of eight specimens each will be defined according to the pulp capping method. Group A, will receive chemical set calcium hydroxide (Dycal). Group B, will receive mineral Trioxide Aggregate (MTA) according to manufacturer's instruction. Group C, will receive MTA and after its primary setting, within 15 minutes, the cavity is restored in the same appointment. Group D, will receive Multical as a direct pulp capping agent. Specimens will be assessed in the terms of dentinal bridge formation, its appearance compared to natural dentin, its thickness and inflammatory pulpal response. The last item will be scored 0-3 in which 0 corresponds to none, 1 to minimal, 2 to moderate and 3 to severe inflammation. In case of an abscess or true tissue necrosis, a score of 4 will be given as recommended by ISO / TC 7405.

Official Title
-----------------
Comparison of Human Pulpal Response After Pulpal Exposure to Common Treatments and Single-visit MTA

Conditions
-----------------
Dental Pulp Exposure

Intervention / Treatment
-----------------
* Drug: Pro Root MTA
* Drug: Pro Root MTA- single visit
* Drug: MultiCal
* Drug: Dycal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aging from 10 to 16 Patients who need to extract 4 premolars for orthodontic purposes the teeth should be free of caries and clinical symptoms Through thermal tests and radiographic examination absence of any pathology is confirmed. Periapical radiographs demonstrating absence of any pathology no sensitivity to percussion, palpation and biting, no sensitivity to cold after 5 seconds contact with Green Endo Ice refrigerant spray, heat sensitivity after applying tempered Gutta Percha for 10 seconds. Absence of any systematic disorder No consumption of drugs of any kind All patients and their parents need to sign a fully informed consent. Exclusion Criteria: If any of the teeth shows caries, restoration, crack or hypocalcification presence of any periapical pathosis Teeth that seem sensitive to cold, hot, percussion or pressure any systematic disorder consumption of drugs of any kind.

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 16 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pro Root MTA- standard method<br>application of MTA in second group and 24 hour interval before restoration | Drug: Pro Root MTA<br>* application of MTA in second group and 24 hour interval before restoration<br>* Other names: Mineral Trioxide Aggregate;|
| Experimental: Pro Root MTA- single visit<br>Intervention/Control application of MTA in third group and 15 minute interval before restoration | Drug: Pro Root MTA- single visit<br>* application of MTA in third group and 15 minute interval before restoration<br>* Other names: Mineral Trioxide Aggregate;|
| Experimental: MultiCal / LimeLite<br>application of Multical in forth group | Drug: MultiCal<br>* application of Multical in forth group as a pulp dressing agent<br>* Other names: Hard set calcium hydroxide paste;|
| Active Comparator: Dycal<br>application of Dycal in first group as a pulp dressing agent | Drug: Dycal<br>* application of Dycal in first group as a pulp dressing agent<br>* Other names: chemical set calcium hydroxide;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| histologic findings - inflammation of the pulp | According to histological evaluation and ISO/DIS7405, the investigators gave to non inflamed cases no points, mild cases 1 point, moderate cases 2 points, severe cases 3 points and necrosis 4 points. | 6weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| histologic findings - formation of the dentinal bridge | The specimens will be evaluated in the terms of dentinal bridge formation and its resemblence to natural dentin and also the thickness of the bridge. | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
direct pulp capping, MTA, Single visit pulp cap, Multical