Clinical and Histological Evaluation of Hesperidin as a Direct Pulp Capping Material

Pulp Exposure, Dental Clinical Trial

Official title:

Clinical and Histological Evaluation of Hesperidin Versus Mineral Trioxide Aggregate (MTA) as a Direct Pulp Capping Material: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06402032
• Other study ID #: Hesperidin_MTA
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Dental Pulp Capping
• Dental Pulp Exposure
• Pulp Exposure, Dental

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