NCT05597553

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 28, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

December 5, 2022

Status Verified

December 1, 2022

Enrollment Period

Same day

First QC Date

October 19, 2022

Last Update Submit

December 2, 2022

Conditions

Indirect Pulp Capping

Outcome Measures

Primary Outcomes (1)

  • Post operative pain

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

    12months

Secondary Outcomes (2)

  • Pulp vitality

    12months

  • Absence of furcal radiolucency or root resorption

    12months

Study Arms (2)

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.

Other: Premixed MTAOther: Powder/liquid MTA

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.

Other: Premixed MTAOther: Powder/liquid MTA

Interventions

Premixed MTAOTHER

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

Also known as: MTA Putty
Powder/liquid MTAPremixed MTA
Powder/liquid MTAOTHER

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 MTAPremixed MTA

Eligibility Criteria

Age6 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Clinical symptoms of irreversible pulpitis requiring endodontic treatment.
  • Clinical symptoms of pulp exposure.
  • The presence of fistulas or swelling.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 28846134RESULT

  • 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.

    PMID: 33483869RESULT

  • 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.

    PMID: 34759576RESULT

MeSH Terms

Interventions

Powders

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical Preparations

Study Officials

  • Mai Mohamed, Lecturer

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

Aisha MK Magdy, BDS

CONTACT

01060259375aisha.abozaid@dentistry.cu.edu.eg

Rania Nasr, Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 19, 2022

First Posted

October 28, 2022

Study Start

January 1, 2023

Primary Completion

January 1, 2023

Study Completion

December 1, 2023

Last Updated

December 5, 2022

Record last verified: 2022-12