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

NCT ID: NCT05597553

Last Updated: 2022-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2023-12-01

Brief Summary

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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

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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-Rootâ„¢ 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-Rootâ„¢ PT does not create an inflammatory response and promotes mineralization.

Conditions

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Indirect Pulp Capping

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Premixed MTA

Intervention Type OTHER

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

Powder/liquid MTA

Intervention Type OTHER

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.

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.

Group Type ACTIVE_COMPARATOR

Premixed MTA

Intervention Type OTHER

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

Powder/liquid MTA

Intervention Type OTHER

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.

Interventions

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Premixed MTA

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

Intervention Type OTHER

Powder/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.

Intervention Type OTHER

Other Intervention Names

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MTA Putty

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Aisha Magdy Khairy Abozaid

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mai Mohamed, Lecturer

Role: STUDY_DIRECTOR

Cairo University

Central Contacts

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Aisha MK Magdy, BDS

Role: CONTACT

01060259375

Rania Nasr, Professor

Role: CONTACT

References

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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.

Reference Type RESULT
PMID: 28846134 (View on PubMed)

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.

Reference Type RESULT
PMID: 33483869 (View on PubMed)

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.

Reference Type RESULT
PMID: 34759576 (View on PubMed)

Other Identifiers

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PM Mta verses P/L

Identifier Type: -

Identifier Source: org_study_id

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