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

Not Applicable

Not yet recruiting

• Conditions: Indirect Pulp Capping
• Interventions: Other: Premixed MTA; Other: Powder/liquid MTA

• Registration Number: NCT05597553
• Lead Sponsor: Cairo University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-10-19
• Study First Submitted QC: 2022-10-24
• Study First Posted: 2022-10-28
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-02
• Last Update Posted: 2022-12-05
• Study Start: 2023-01-01
• Primary Completion: 2023-01-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Premixed MTA	Premixed MTA	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.
Premixed MTA	Powder/liquid MTA	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.
Powder/liquid MTA	Premixed MTA	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.
Powder/liquid MTA	Powder/liquid MTA	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.

Primary Outcome Measures

Name	Time	Method
Post operative pain	12months	Clinical examination by(Visual Analogue Scale) System (0 - Mild - Moderate - Severe)

Secondary Outcome Measures

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