Clinical and Radiographic Assessment of Platelet Rich Fibrin and Mineral Trioxide Aggregate as Pulp Capping Biomaterials

Direct Pulp Capping Clinical Trial

Official title:

Clinical and Radiographic Assessment of Platelet Rich Fibrin and Mineral Trioxide Aggregate as Pulp Capping Biomaterials: A Randomized Control Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04488679
• Other study ID #: 111261
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2022
• Est. completion date: October 2023

Study information

• Verified date: August 2022
• Source: Cairo University
• Contact: Rahma Ah Abuhashema, MSc
• Phone: 01003674989
• Email: rahma.ibrahem[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

eligible carious teeth with exposed pulp by the undergraduate students will be randomly divided into two groups to be treated with direct pulp capping (A), where (A1) represents the comparator group where teeth will be treated with direct application of MTA over the exposed pulp, (A2) represents teeth to be treated with the application of PRF directly over exposed pulp followed by MTA application. clinical and radiographic assessment of tooth vitality, history of pain, pain on percussion, and dentin bridge formation will be performed at baseline, 6 months, and 1 year

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 66
• Est. completion date: October 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 35 Years

Eligibility

Inclusion Criteria:

• Patient aged 15:40 years old.

• Patients exhibiting pulp exposure (carious, traumatic, or mechanical) during management of active carious lesions with less than 2 mm of carious exposure.

• Signs and symptoms indicative of pulp vitality, i.e. a positive response to thermal stimulation during a cold test.

• periapical radiograph showing closed apex and normal periapex

Exclusion Criteria:

• Teeth with spontaneous pain or sensitivity to percussion (signs of irreversible pulpitis).

• Teeth with periodontal lesions, internal or external root resorption, calcified canals, mobility of tooth, sinus opening, or abscessed tooth.

• Non restorable tooth.

• Radiographic examination revealed, interrupted or broken lamina dura, widened periodontal ligament space, periapical radiolucency.

• Pulp bleeding that could not be controlled within 10 minutes using 2.5% sodium hypochlorite

• Immune-compromised patients or with systemic medical disorders.

• pregnant females

Related Conditions & MeSH terms

• Direct Pulp Capping

Intervention

Other:
• direct pulp capping
teeth with exposed pulp during caries removal will be capped either with PRF followed by mta or mta alone directly on exposed pulp, in both groups restoration will be placed over mta

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rahma Ahmed Ibrahem Hafiz

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical success rate	pulp vitality by thermal pulp testing	6 months
Primary	clinical success rate	history of pain	6 months
Primary	clinical success rate	pain on percussion	6 months
Primary	clinical success rate	radiographic signs of pulp necrosis and apical periodontitis	6 months
Primary	clinical success rate	pulp vitality by thermal pulp testing	1 year
Primary	clinical success rate	history of pain	1 year
Primary	clinical success rate	no pain on percussion	1 year
Primary	clinical success rate	radiographic signs of pulp necrosis and apical periodontitis	1 year
Secondary	radiographic assessment of regerenerative dentin formation(dentin bridge)	assessment of dentin bridge by digital radiography (digrora software)	6 months
Secondary	radiographic assessment of incidence of regenerative dentin (dentin bridge)	assessment of dentin bridge by digital radiography (digrora software)	1 year