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

May 3, 2024 updated by: Dina Mohamed Kamal Eldin, Cairo University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Faculty of Dentistry Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hesperidin
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-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.
Active Comparator: Mineral trioxide aggregate (MTA)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success Rate (Clinical evaluation)
Time Frame: after 12 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Histomorphometric analysis (Histologic evaluation)
Time Frame: after 12 weeks
Thickness of formed dentin bridge (μm)
after 12 weeks
Histomorphometric analysis (Histologic evaluation)
Time Frame: after 12 weeks
Number of inflammatory cells in pulp (scores for Inflammation intensity/extensity)
after 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Actual)

December 1, 2023

Study Completion (Actual)

March 30, 2024

Study Registration Dates

First Submitted

April 30, 2024

First Submitted That Met QC Criteria

May 3, 2024

First Posted (Actual)

May 7, 2024

Study Record Updates

Last Update Posted (Actual)

May 7, 2024

Last Update Submitted That Met QC Criteria

May 3, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hesperidin_MTA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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