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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05597553
Enrollment
24
Registered
2022-10-28
Start date
2023-01-01
Completion date
2023-12-01
Last updated
2022-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Indirect Pulp Capping

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.

Interventions

OTHERPremixed MTA

The premixed Bio-ceramic putty during setting become hard and expand slightly providing a superior long-term seal

OTHERPowder/liquid MTA

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.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Intervention 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

Eligibility

Sex/Gender
ALL
Age
6 Years to 8 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Post operative pain12monthsClinical examination by(Visual Analogue Scale) System (0 - Mild - Moderate - Severe)

Secondary

MeasureTime frameDescription
Pulp vitality12monthsEvaluate of pulp vitality by Electrical pulp test 9Normal response, Exaggerated brief Exaggerated prolong, Negative)
Absence of furcal radiolucency or root resorption12monthsEvaluate Periapical Intraoral Digital Radiography if present or absent

Contacts

Primary ContactAisha MK Magdy, BDS
aisha.abozaid@dentistry.cu.edu.eg01060259375
Backup ContactRania Nasr, Professor

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026