Indirect Pulp CapNCT07183514
A Study Comparing Eggshell Based and Gold Standard Materials to Heal Deep Tooth Damage in Adult Molars
A study testing eggshell-derived calcium hydroxyapatite and Calcium hydroxide in people with Indirect Pulp Cap, run by University of Health Sciences Lahore at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Indirect Pulp Cap
- What is being tested?
- eggshell-derived calcium hydroxyapatite and Calcium hydroxide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Sep 2025to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
- -
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
de'Montmorency college of dentistry Lahore
Lahore, Punjab Province, 54000
shazia naz, MDS operative dentistry, +92 321 4614543, dr.shazianaz210@gmail.com
About this study
Official title: Clinical and Radiographic Evaluation of Eggshell-derived Calcium Hydroxyapatite Verses Calcium Hydroxide as In-direct Pulp Capping Agent in Permanent 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.
Read the detailed description
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.
- Conditions
- Indirect Pulp Cap
- Being tested
- eggshell-derived calcium hydroxyapatite, Calcium hydroxide
- Keywords
- dental caries, indirect pulp capping, hydroxyapatite, reparative dentine
- Medical subject headings
- Dental Caries, Dentin, Secondary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eggshell-derived calcium hydroxyapatiteBiological
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 hydroxideBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| eggshell-derived calcium hydroxyapatite | Experimental | Participants in this arm will receive indirect pulp capping with eggshell-derived calcium hydroxyapatite, followed by restoration with glass ionomer cement and composite resin. Receives: Biological: eggshell-derived calcium hydroxyapatite |
| Calcium hydroxide | Active comparator | Participants in this arm will receive indirect pulp capping with Calcium hydroxide, followed by restoration with glass ionomer cement and composite resin. Receives: Biological: Calcium hydroxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (1)
restoration success, post operative sensitivity
Records patient-reported sensitivity and discomfort
Measured: baseline to seven days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start20 Sep 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Indirect Pulp CapStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Health Sciences Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arooj fatima, University of Health Sciences Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07183514
- Sponsor's protocol ID
- PGMI-LHR-2024-59
- Status last verified
- Sep 2025
- First submitted
- 8 Sep 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40355679Reddy, 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Eggshell-derived Calcium Hydroxyapatite Verses Calcium Hydroxide as In-direct Pulp Capping Agent in Permanent Molars
- ClinicalTrials.gov ID
- NCT07183514
- Acronym / sponsor ID
- PGMI-LHR-2024-59
- Conditions
- Indirect Pulp Cap
- Keywords
- dental caries, indirect pulp capping, hydroxyapatite, reparative dentine
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- University of Health Sciences LahoreUniversity, hospital or other
- Study start
- 20 Sep 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 19 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| eggshell-derived calcium hydroxyapatite | Experimental | Biological: eggshell-derived calcium hydroxyapatiteParticipants 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 comparator | Biological: Calcium hydroxideParticipants in this arm will receive indirect pulp capping with Calcium hydroxide, followed by restoration with glass ionomer cement and composite resin. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
- -
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eggshell-derived calcium hydroxyapatiteeggshell-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. | Biological | eggshell-derived calcium hydroxyapatite |
| Calcium hydroxideCalcium 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. | Biological | Calcium hydroxide |
Primary outcome
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.
1 secondary outcome
restoration success, post operative sensitivity
Time frame: baseline to seven days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Background: PubMed 40355679Swarup 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.
- BackgroundReddy, 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.
- 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 formationLink provided by the sponsor.
- 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 dentistryLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eggshell-derived calcium hydroxyapatite and Calcium hydroxide in people with Indirect Pulp Cap, run by University of Health Sciences Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arooj fatima, PG trainee MDS operative (+92 313 5997971, Aroojasghar9992@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical symptoms (pain on percussion, tooth mobility) and radiographic evaluation (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07183514, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.