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

Indirect Pulp Capping Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05928858
• Other study ID #: 14422022585603
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: September 2023
• Est. completion date: September 2024

Study information

• Verified date: July 2023
• Source: Cairo University
• Contact: Aya Ad Hamza, Phd
• Phone: 01062315566
• Email: aya.adel[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: September 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Indirect Pulp Capping

Intervention

Drug:
• Premixed Bio-ceramic MTA
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
• Calcium 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immediate Postoperative pain	post 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.	one week
Secondary	The thickness of newly formed dentin	The thickness of newly formed dentin will be assessed in Mm through Digora software	3,6,9,12 month
Secondary	Soft tissue pathology	Swelling, sinus tract, fistula, mobility and pain on percussion will be assessed by clinical examination either present or not (binary)	3,6,9,12 month
Secondary	Radiographic changes	Radiolucency 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)	3,6,9,12 month