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

NCT06402032 | Completed

• 1 other identifier: Hesperidin_MTA
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Histomorphometric analysis (Histologic evaluation)

  after 12 weeks

• Histomorphometric analysis (Histologic evaluation)

  after 12 weeks

Study Arms (2)

Hesperidin

EXPERIMENTAL

Other: Hesperidin

Mineral trioxide aggregate (MTA)

ACTIVE COMPARATOR

Other: Mineral Trioxide Aggregate (MTA)

Interventions

Hesperidin 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.

Hesperidin

Mineral Trioxide Aggregate (MTA) 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.

Mineral trioxide aggregate (MTA)

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Dental Pulp Exposure

Interventions

Hesperidin; mineral trioxide aggregate

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Flavanones; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Glycosides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, Faculty of Dentistry

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 7, 2024
• Study Start: September 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: March 30, 2024
• Last Updated: May 7, 2024

Record last verified: 2024-05

Locations

EG (1)