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Completed

NCT Number: NCT06402032

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

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.

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Key information

Conditions

Pulp Exposure, Dental Dental Pulp Capping Dental Pulp Diseases Dental Pulp Exposure Stomatognathic Diseases Tooth Diseases

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry Cairo University

Cairo, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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 (%)

Secondary outcomes

  1. Histomorphometric analysis (Histologic evaluation)

    Time frame: after 12 weeks

    Thickness of formed dentin bridge (μm)

  2. Histomorphometric analysis (Histologic evaluation)

    Time frame: after 12 weeks

    Number of inflammatory cells in pulp (scores for Inflammation intensity/extensity)

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
May 7, 2024
Registry last updated
May 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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