Clinical trial NCT05597553: Evaluation of Premixed Verses Powder/Liquid Bioceramic MTA in Indirect Pulp Capping.
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Indirect Pulp Capping
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-10-28
Enrollment: 24
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Post operative pain
timeFrame: 12months
Secondary outcomes:
measure: Pulp vitality
timeFrame: 12months
measure: Absence of furcal radiolucency or root resorption
timeFrame: 12months
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Mai Mohamed, Lecturer
role: STUDY_DIRECTOR
References:
citation: Torabinejad M, Parirokh M, Dummer PMH. Mineral trioxide aggregate and other bioactive endodontic cements: an updated overview - part II: other clinical applications and complications. Int Endod J. 2018 Mar;51(3):284-317. doi: 10.1111/iej.12843. Epub 2017 Oct 11.
citation: Abdelmotelb MA, Gomaa YF, Khattab NMA, Elheeny AAH. Premixed bioceramics versus mineral trioxide aggregate in furcal perforation repair of primary molars: in vitro and in vivo study. Clin Oral Investig. 2021 Aug;25(8):4915-4925. doi: 10.1007/s00784-021-03800-3. Epub 2021 Jan 22.
citation: Motwani N, Ikhar A, Nikhade P, Chandak M, Rathi S, Dugar M, Rajnekar R. Premixed bioceramics: A novel pulp capping agent. J Conserv Dent. 2021 Mar-Apr;24(2):124-129. doi: 10.4103/JCD.JCD_202_20. Epub 2021 Oct 9.