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NCT Number: NCT07183514

A Study Comparing Eggshell Based and Gold Standard Materials to Heal Deep Tooth Damage in Adult Molars

This clinical trial will evaluate the effectiveness of eggshell-derived calcium hydroxyapatite compared to calcium hydroxide as indirect pulp capping agent in permanent teeth. A total of 54 teeth from healthy individuals aged 18 to 40 years will be randomly allocated into two groups:

Group A (experimental) treated with eggshell-derived calcium hydroxyapatite. Group B (control) treated with calcium hydroxide.

After caries removal the assigned pulp capping agent will be applied, and the teeth will be restored. Clinical and radiographic evaluations will be performed at 1 and 3 months to assess pulp vitality, symptom-free status, and periapical health.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

de'Montmorency college of dentistry Lahore

Lahore, Punjab Province, 54000, Pakistan

Location contact

shazia naz, MDS operative dentistry

CONTACT

[email protected]

+92 321 4614543

About this study

Dental caries is the most prevalent bacterial disease affecting both primary and permanent dentition. Modern dental practice emphasizes minimally invasive techniques that preserve pulp vitality. Indirect pulp capping is one such procedure, performed in teeth without signs of irreversible pulpitis, where infected dentine is removed while caries-affected dentine (CAD) is preserved and covered with a biocompatible material.

Calcium hydroxide remains the most widely used pulp capping material despite its shortcomings. Hydroxyapatite, a stable synthetic calcium phosphate ceramic, has demonstrated excellent biocompatibility. Eggshells are a natural, abundant source of calcium carbonates and oxides, making them a promising precursor for hydroxyapatite.

This randomized, double-blind clinical trial aims to evaluate and compare the clinical and radiographic outcomes of eggshell-derived calcium hydroxyapatite and calcium hydroxide as indirect pulp capping agents in permanent teeth with deep caries. Fifty-four teeth from healthy individuals aged 18-40 will be included. Random allocation will be performed using the lottery method.

Group A (experimental) will receive eggshell-derived calcium hydroxyapatite, while Group B (control) will receive calcium hydroxide. Following rubber dam isolation and chemo-mechanical caries removal with carie-fix gel, infected dentine will be removed using a spoon excavator while CAD is preserved. The allocated pulp capping agent will be placed over CAD, followed by restoration with glass ionomer cement (GC Gold Label II) and composite resin.

Clinical and radiographic assessments will be carried out at 1 month and 3 months. Clinical evaluation will include pulp vitality, pain on percussion, and mobility. Radiographic assessment will include reparative dentine thickness and absence of periapical pathology.

The findings will determine whether eggshell-derived calcium hydroxyapatite can be considered a viable natural alternative to calcium hydroxide for indirect pulp capping.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Teeth with symptoms of reversible pulpitis.
  • Teeth that show positive response on electric pulp testing (EPT).
  • Teeth with caries penetrating up to three-quarters (¾) of dentine without pulp involvement.
  • Healthy cooperative patients of both sexes between 18 to 40 years of age.

-

Exclusion criteria

  • Necrosed Teeth with radiolucency in the periapical and furcation regions.
  • Tooth with internal and external root resorption.
  • Periodontally compromised tooth. (BPE score 3 and above)
  • Physically and mentally handicapped patients. (ASA score 3 and above)

Treatment and study plan

eggshell-derived calcium hydroxyapatite

Biological

eggshell-derived calcium hydroxyapatite will be placed as an indirect pulp capping material after chemo-mechanical caries removal and before final restoration with glass ionomer cement and composite resin.

Calcium hydroxide

Biological

Calcium hydroxide will be placed as an indirect pulp capping material after chemo-mechanical caries removal and before final restoration with glass ionomer cement and composite resin.

Primary outcomes

  1. clinical symptoms (pain on percussion, tooth mobility) and radiographic evaluation

    Time frame: 3 months

    Evaluates absence of pain and pathological mobility, Measures dentine bridge thickness and absence of periapical pathology.

Secondary outcomes

  1. restoration success, post operative sensitivity

    Time frame: baseline to seven days

    Records patient-reported sensitivity and discomfort

Study contacts

Contact information is provided by the study sponsor or research team.

Arooj fatima, PG trainee MDS operative

CONTACT

[email protected]

+92 313 5997971

Shazia Naz, MDS operative dentistry

CONTACT

[email protected]

+ 92 321 4614543

Sponsors and collaborators

Lead sponsor

University of Health Sciences Lahore

Other

Registry information

Official study title

Clinical and Radiographic Evaluation of Eggshell-derived Calcium Hydroxyapatite Verses Calcium Hydroxide as In-direct Pulp Capping Agent in Permanent Molars

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Sep 19, 2025
Registry last updated
Sep 19, 2025

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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