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Clinical Trials/NCT05597553
NCT05597553
Not yet recruiting
Not Applicable

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

Cairo University0 sites24 target enrollmentJanuary 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Indirect Pulp Capping
Sponsor
Cairo University
Enrollment
24
Primary Endpoint
Post operative pain
Status
Not yet recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2023
End Date
December 1, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Aisha Magdy Khairy Abozaid

Principal Investigator

Cairo University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Post operative pain

Time Frame: 12months

Clinical examination by(Visual Analogue Scale) System (0 - Mild - Moderate - Severe)

Secondary Outcomes

  • Absence of furcal radiolucency or root resorption(12months)
  • Pulp vitality(12months)

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