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Clinical Trials/NCT05597553
NCT05597553Not yet recruitingNot 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 enrollmentStarted: January 1, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
24
Primary Endpoint
Post operative pain

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Ages
6 Years to 8 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

Premixed MTA

Experimental

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.

Intervention: Premixed MTA (Other)

Premixed MTA

Experimental

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.

Intervention: Powder/liquid MTA (Other)

Powder/liquid MTA

Active Comparator

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.

Intervention: Premixed MTA (Other)

Powder/liquid MTA

Active Comparator

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.

Intervention: Powder/liquid MTA (Other)

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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Aisha Magdy Khairy Abozaid

Principal Investigator

Cairo University

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