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

NCT ID: NCT06402032

Last Updated: 2024-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2024-03-30

Brief 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.

Conditions

Pulp Exposure, Dental; Dental Pulp Capping

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Hesperidin

Group Type: EXPERIMENTAL

Hesperidin

Intervention Type: OTHER

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-κB 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)

Group Type: ACTIVE_COMPARATOR

Mineral Trioxide Aggregate (MTA)

Intervention Type: OTHER

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.

Interventions

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-κB 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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Dina Mohamed Kamal Eldin

Lecturer, Faculty of Dentistry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Dentistry Cairo University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

Hesperidin_MTA

Identifier Type: -

Identifier Source: org_study_id