A Study Comparing Eggshell Based and Gold Standard Materials to Heal Deep Tooth Damage in Adult Molars
Clinical and Radiographic Evaluation of Eggshell-derived Calcium Hydroxyapatite Verses Calcium Hydroxide as In-direct Pulp Capping Agent in Permanent Molars
1 other identifier
interventional
54
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 8, 2025
CompletedFirst Posted
Study publicly available on registry
September 19, 2025
CompletedStudy Start
First participant enrolled
September 20, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2026
CompletedSeptember 19, 2025
September 1, 2025
3 months
September 8, 2025
September 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
clinical symptoms (pain on percussion, tooth mobility) and radiographic evaluation
Evaluates absence of pain and pathological mobility, Measures dentine bridge thickness and absence of periapical pathology.
3 months
Secondary Outcomes (1)
restoration success, post operative sensitivity
baseline to seven days
Study Arms (2)
eggshell-derived calcium hydroxyapatite
EXPERIMENTALParticipants in this arm will receive indirect pulp capping with eggshell-derived calcium hydroxyapatite, followed by restoration with glass ionomer cement and composite resin.
Calcium hydroxide
ACTIVE COMPARATORParticipants in this arm will receive indirect pulp capping with Calcium hydroxide, followed by restoration with glass ionomer cement and composite resin.
Interventions
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 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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
de'Montmorency college of dentistry Lahore
Lahore, Punjab Province, 54000, Pakistan
Related Publications (2)
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: 40355679BACKGROUNDReddy, 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.
BACKGROUND
Related Links
- A randomized clinical study comparing eggshell-derived calcium hydroxyapatite with Dycal® (calcium hydroxide) for indirect pulp capping in primary molars. The eggshell-derived hydroxyapatite group showed significantly greater reparative dentine formation
- A scoping review covering synthesis, properties, and dental applications of eggshell-derived hydroxyapatite (E-HAp), including its use in pulp capping and regenerative endodontics. Provides comprehensive background on E-HAp's potential in dentistry
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
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
- Post- graduate trainee in operative dentistry department PGMI Lahore
Study Record Dates
First Submitted
September 8, 2025
First Posted
September 19, 2025
Study Start
September 20, 2025
Primary Completion
December 31, 2025
Study Completion
March 31, 2026
Last Updated
September 19, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share