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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Биопрепарат eggshell-derived calcium hydroxyapatite
  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.
• Биопрепарат Calcium hydroxide
  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.

Первичные конечные точки

• clinical symptoms (pain on percussion, tooth mobility) and radiographic evaluation [Срок оценки: 3 months]

Вторичные конечные точки (1)

• restoration success, post operative sensitivity [Срок оценки: baseline to seven days]

Критерии участия

Критерии включения

• 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.

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Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Пакистан · 1 центр

• de'Montmorency college of dentistry Lahore — Lahore

Публикации

• Swarup JS, Thomas R, Rucharitha J, Arunkumar VR, V V. Eggshell-derived hydroxyapatite as a biomaterial in dentistry: a scoping review of synthesis, properties and applications. Evid Based Dent. 2025 Sep;26(3):153. doi: 10.1038/s41432-025-01146-3. Epub 2025 May 12. PMID 40355679
• Reddy, S.P. et al. (2020a) 'Clinical comparison of eggshell derived calcium hydroxyapatite with Dycal® as indirect pulp capping agents in primary molars', Pesquisa Brasileira em Odontopediatria e Clínica Integrada, 20.(e0041):1-9 doi:10.1590/pboci.2020.151.

Идентификаторы

NCT: NCT07183514 · PGMI-LHR-2024-59

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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