Evaluation of Premixed Verses Powder/Liquid Bioceramic MTA in Indirect Pulp Capping.

Study Overview
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Brief Summary
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Evaluate Clinical and Radiographic Evaluation of Premixed verses Powder / Liquid Bioceramic Mineral Trioxide Aggregate in Indirect Pulp Capping of Immature Permanent Mandibular Molars

Detailed Description
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Mineral trioxide aggregate (MTA) is a bioactive, biocompatible, antibacterial material with good stability, and excellent sealing ability that has been used as a dressing material in pulp capping procedures in permanent teeth. Although it has good properties, MTA has many limitations, including long setting time, handling property and tooth discoloration making the use of this material challenging for many clinicians. Researchers and manufacturers have made progress in overcoming these problems in recent years, new and improved products are becoming available such as the premixed bioceramic putty. The premixed bioceramics putty are ready to use materials, fast setting, with superior handling properties and hydrophilic in nature that necessitate moisture from the adjacent tissues to set. They have advantage of insensitive to moisture and blood contamination with less technique sensitive. Upon setting, they become hard and expand slightly providing with superior long-term seal. Premixed Bio-ceramics (BC) are highly alkaline materials (pH = 12.7), they release calcium and have antibacterial activity. Their biocompatibility is higher than that of MTA, this is attributed to the absence of heavy metals from the premixed BC components. The premixed bio-ceramic putty (Well-Root™ PT) has been developed for the management of pulp capping procedures with the advantage of uniform homogenous consistency and lack of waste. It is radiopaque material based on a calcium aluminosilicate composition. It has excellent biological & physical properties and does not shrink during setting. Well-Root™ PT does not create an inflammatory response and promotes mineralization.

Official Title
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Clinical and Radiographic Evaluation of Premixed Verses Powder / Liquid Bioceramic Mineral Trioxide Aggregate in Indirect Pulp Capping of Immature Permanent Mandibular Molars: A Randomized Clinical Trial

Conditions
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Indirect Pulp Capping

Intervention / Treatment
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* Other: Premixed MTA
* Other: Powder/liquid MTA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Medically fit and cooperative children. Pediatric patients aged 6-8 years. Deep caries with reversible pulpits in immature first permanent mandibular molars indicated for indirect pulp capping. Absence of clinical signs and symptoms of pulpal exposure. Absence of radiographic signs and symptoms of pulp degeneration. Positive parental informed consent. Exclusion Criteria: Clinical symptoms of irreversible pulpitis requiring endodontic treatment. Clinical symptoms of pulp exposure. The presence of fistulas or swelling.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Mineral trioxide aggregate (MTA) is a bioactive, biocompatible, antibacterial material with good stability and excellent sealing ability that has been used as a dressing material in pulp capping procedures in permanent teeth
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Premixed MTA<br>The premixed bioceramics putty are ready to use materials, fast setting, with superior handling properties and hydrophilic in nature that necessitate moisture from the adjacent tissues to set. They have advantage of insensitive to moisture and blood contamination with less technique sensitive. | Other: Premixed MTA<br>* The premixed Bio-ceramic putty during setting become hard and expand slightly providing a superior long-term seal<br>* Other names: MTA Putty;Other: Powder/liquid MTA<br>* Mineral trioxide aggregate (MTA) is a silicate material that is said to aid in faster bridge formation with fewer tunnel defects, less pulpal inflammation, and the maintenance of pulpal integrity. It is widely used in pediatric dentistry due to its excellent sealing properties.<br>|
| Active Comparator: Powder/liquid MTA<br>Mineral trioxide aggregate (MTA) is a bioactive, biocompatible, antibacterial material with good stability, and excellent sealing ability that has been used as a dressing material in pulp capping procedures in permanent teeth, although it has good properties, it has many limitations, including long setting time, handling property and tooth discoloration making the use of this material challenging for many clinicians. | Other: Premixed MTA<br>* The premixed Bio-ceramic putty during setting become hard and expand slightly providing a superior long-term seal<br>* Other names: MTA Putty;Other: Powder/liquid MTA<br>* Mineral trioxide aggregate (MTA) is a silicate material that is said to aid in faster bridge formation with fewer tunnel defects, less pulpal inflammation, and the maintenance of pulpal integrity. It is widely used in pediatric dentistry due to its excellent sealing properties.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post operative pain | Clinical examination by(Visual Analogue Scale) System (0 - Mild - Moderate - Severe) | 12months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulp vitality | Evaluate of pulp vitality by Electrical pulp test 9Normal response, Exaggerated brief Exaggerated prolong, Negative) | 12months | 
| Absence of furcal radiolucency or root resorption | Evaluate Periapical Intraoral Digital Radiography if present or absent | 12months |