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

Sponsor

Cairo University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05597553

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Indirect Pulp Capping	Other: Premixed MTA Other: Powder/liquid MTA	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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 teethMineral 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

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Other: Premixed MTA The premixed Bio-ceramic putty during setting become hard and expand slightly providing a superior long-term seal Other Names: MTA Putty 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.
Active Comparator: 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.	Other: Premixed MTA The premixed Bio-ceramic putty during setting become hard and expand slightly providing a superior long-term seal Other Names: MTA Putty 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.

Arm

Intervention/Treatment

Experimental: Premixed MTA

Other: Premixed MTA

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

Other Names:

MTA Putty

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.

Active Comparator: 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.

Other: Premixed MTA

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

Other Names:

MTA Putty

Other: Powder/liquid MTA

Outcome Measures

Primary Outcome Measures

Post operative pain [12months]
Clinical examination by(Visual Analogue Scale) System (0 - Mild - Moderate - Severe)

Secondary Outcome Measures

Pulp vitality [12months]
Evaluate of pulp vitality by Electrical pulp test 9Normal response, Exaggerated brief Exaggerated prolong, Negative)
Absence of furcal radiolucency or root resorption [12months]
Evaluate Periapical Intraoral Digital Radiography if present or absent

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 8 Years

Sexes Eligible for Study:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Cairo University

Investigators

Study Director: Mai Mohamed, Lecturer, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Aisha Magdy Khairy Abozaid, Principal Investigator, Cairo University

ClinicalTrials.gov Identifier:

NCT05597553

Other Study ID Numbers:

PM Mta verses P/L

First Posted:

Oct 28, 2022

Last Update Posted:

Dec 5, 2022

Last Verified:

Dec 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pemetrexed

Study Results

No Results Posted as of Dec 5, 2022