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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06402032
Other study ID # Hesperidin_MTA
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2022
Est. completion date March 30, 2024

Study information

Verified date May 2024
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Direct pulp capping technique is one of the oldest known treatments for exposed pulp tissue, and there is a continuous requirement for the most efficient materials to be used in this approach. Successful pulp capping is the usual way to preserve the vitality of tooth and avoid root canal treatment or surgical tooth extraction.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date March 30, 2024
Est. primary completion date December 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: - Good oral hygiene, - Sound wisdom teeth with closed apices with normal pulp vitality response - No periodontal disease or periapical lesions on periapical radiograph - Cooperative patients approving to participate in the study Exclusion Criteria: - Medically compromised participants - Evidence of parafunctional habits - Heavy smokers - Teeth with signs and symptoms of irreversible pulpitis or pulp necrosis - Severe periodontal problems or pathological periapical changes - Teeth with open apex or pulp calcification

Study Design


Intervention

Other:
Hesperidin
Hesperidin is a natural flavonoid with well-known of its anti-inflammatory properties in many disease. Hesperidin in previous studies has been documented to reduce inflammation as well as pain through suppression of cytokine production, NF-?B activity, and oxidative stress. Hesperidin, as a natural product, have been considered as a promising pulp capping material in several invitro and animal studies. However, the regenerative effect of hesperidin as pulp capping material in human teeth has not yet been reported.
Mineral Trioxide Aggregate (MTA)
Mineral trioxide aggregate is a cementitious material having various advantages as it is biocompatible, bioactive, osteo-inductive, non-resorbable material with exciting clinical applications, stimulating reparative continuous dentin formation along with maintaining the integrity of the pulp. Moreover, mineral trioxide aggregate provides seal to tooth structure and is of high strength. It is considered the gold standard material for direct pulp capping.

Locations

Country Name City State
Egypt Faculty of Dentistry Cairo University Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Success Rate (Clinical evaluation) Teeth with vital pulp (numerical values with electric pulp tester) and absence of clinical signs/symptoms (Visual Analog Score for pain) as one reported value indicating clinical success rate (%) after 12 weeks
Secondary Histomorphometric analysis (Histologic evaluation) Thickness of formed dentin bridge (µm) after 12 weeks
Secondary Histomorphometric analysis (Histologic evaluation) Number of inflammatory cells in pulp (scores for Inflammation intensity/extensity) after 12 weeks
See also
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Enrolling by invitation NCT05397964 - Retrospective Evaluation of the Results of Direct Pulp Capping Treatment
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Active, not recruiting NCT06171776 - Evaluation of Conservative Management of Teeth With Deep Cavitated Carious Lesions Phase 2/Phase 3
Recruiting NCT05878158 - Simvastatin Versus MTA in Pulpotomy of Immature Permanent Molars Early Phase 1
Recruiting NCT05812053 - Comparative Evaluation of Eggshell Powder in Primary Teeth Pulpotomy N/A