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Clinical And Radiographic Evaluation Of Premixed Bio-ceramic MTA In Indirect Pulp Capping Of Young Permanent Molars

Clinical And Radiographic Evaluation Of Premixed Bio-ceramic Mineral Trioxide Aggregate Versus Calcium Hydroxide In Indirect Pulp Capping Of Young Permanent Molars: A Randomized Controlled Trial

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05928858
Enrollment
40
Registered
2023-07-03
Start date
2023-09-30
Completion date
2024-09-30
Last updated
2023-08-01

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

Conditions

Indirect Pulp Capping

Keywords

neoputty, premixed bioceramic MTA, young permanent teeth, calcium hydroxide

Brief summary

The present study aims to evaluate the clinical and radiographic success of premixed bio-ceramic MTA versus calcium hydroxide in indirect pulp capping of young permanent molars.

Detailed description

Researchers are still in search of an ideal material for pulp capping, and they evaluated numerous dental materials. For many decades, calcium hydroxide has been the 'gold standard' material for maintaining pulp vitality. Both clinically and histologically, it has been found to produce satisfactory results in indirect and direct pulp capping because it can stimulate the formation of tertiary dentine by the pulp and it has antimicrobial properties. Due to the drawbacks of calcium hydroxide, several materials have been developed, such as NeoPUTTY which is premixed bio-ceramic Mineral Trioxide Aggregate (MTA) that triggers hydroxyapatite. Its firm, non-tacky consistency, wash-out resistance, and bioactivity make it a pediatric dentists' preferred material for every pulp need. It also delivers ready-to-use material for immediate placement with zero waste, saving cost and chair time.

Interventions

Partial caries removal will be carried out then Premixed Bio-ceramic MTA will be applied as indirect pulp capping agent followed by Glass ionomer filling and composite restoration

DRUGCalcium hydroxide

Partial caries removal will be carried out then calcium hydroxide will be applied as indirect pulp capping agent followed by Glass ionomer filling and composite restoration

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

Randomized controlled trial

Eligibility

Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
Yes

Inclusion criteria

* Patients who have young permanent molars with deep carious lesions. * Restorable young permanent molars with no clinical symptoms of irreversible pulpitis. * Permanent molars with no clinical or radiographic signs of pulp necrosis including swelling, fistula, pain on percussion,pathologic tooth mobility, thickening of the periodontal ligament space, radiolucency at the periapical area.

Exclusion criteria

* Medically compromised patients who have systemic disease. * Uncooperative patients who refuse treatment * Permanent molars that were previously restored * Children whose parents or caregivers refuse to participate in the study.

Design outcomes

Primary

MeasureTime frameDescription
Immediate Postoperative painone weekpost operative pain by Verbal analogue scale.It is a 10 cm long horizontal line with points labeled from 0 to 10 where (0) indicates no pain, (1-3) mild pain, (4-6) moderate pain, and (7-10) severe pain.

Secondary

MeasureTime frameDescription
The thickness of newly formed dentin3,6,9,12 monthThe thickness of newly formed dentin will be assessed in Mm through Digora software
Soft tissue pathology3,6,9,12 monthSwelling, sinus tract, fistula, mobility and pain on percussion will be assessed by clinical examination either present or not (binary)
Radiographic changes3,6,9,12 monthRadiolucency at the periapical or furcation area and Internal or external root resorption will be assessed through a digital periapical intraoral radiograph either present or not ( Binary)

Contacts

Primary ContactAya Ad Hamza, Phd
aya.adel@dentistry.cu.edu.eg01062315566
Backup ContactSara Ah Mahmoud, Professor

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026