Pulpitis ReversibleNCT05812053
Comparative Evaluation of Eggshell Powder in Primary Teeth Pulpotomy
A study testing pulpotomy and cone beam computed tomography (CBCT) assessment in people with Pulpitis Reversible and Pulp Exposure, Dental, run by Tanta University at 1 site in Egypt.
Trial summary
To assess \& compare clinical \& radiographic effects of Eggshell Powder, Biodentine and MTA as pulpotomy agents in primary teeth. Read more about this study
- Who is it for?
- Ages 4 to 7 years
- Conditions the study is for
- Pulpitis Reversible, Pulp Exposure, Dental
- What is being tested?
- pulpotomy and cone beam computed tomography (CBCT) assessment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2023to 10 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 4 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Restorable primary molars with deep carious lesions.
- Absence of gingival swelling or sinus tract.
- Absence of spontaneous pain
- Absence of pain on percussion.
- Absence of discontinuity of lamina dura
- Absence of internal root resorption.
- Absence of external root resorption.
- Absence of inter-radicular or periapical bone destruction (radiolucency).
Who cannot join
- presence of spontaneous pain
- presence of gingival swelling or sinus tract
- presence of internal or external root resorption
- pain on percussion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Evaluation of Eggshell Powder Versus Biodentine in Primary Teeth Pulpotomy: Clinical And Radiographic Study
To assess \& compare clinical \& radiographic effects of Eggshell Powder, Biodentine and MTA as pulpotomy agents in primary teeth.
Read the detailed description
Pulpotomy is the most widely accepted technique for treating primary teeth with deep carious lesion, pulp exposure during the operatory process or after a traumatic pulp exposure. Mineral trioxide aggregate (MTA) is one such material that has shown tremendous potential for regeneration. Biodentine™ (hydraulic silicate cement) is a novel dental material with high mechanical characteristics as well as superior biocompatibility and bioactive behaviour. Nowadays, chicken eggshell powder (CESP) (a natural calcium-rich source) is achieving wide acceptance in the medical and dental fields. To date, there is insufficient evidence to properly evaluate Eggshell Powder as a pulpotomy agent in primary teeth; thus, the current study aimed to assess and compare clinical and radiographical success of Eggshell Powder, Biodentine and MTA as pulpotomy agents in primary teeth.
- Conditions
- Pulpitis Reversible, Pulp Exposure, Dental
- Being tested
- pulpotomy, cone beam computed tomography (CBCT) assessment
- Keywords
- Cone-beam computed tomography, egg shell powder, biodentine
- Medical subject headings
- Dental Pulp Exposure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulpotomyProcedure or surgery
Teeth will be anesthetized then Rubber dam and high suction will be used in pulpotomy procedure. Cavity outline was performed by sterile #330 high speed bur using water spray. Caries was removed by large spoon excavator. When pulpal exposure occurred, the roof of pulp chamber removed by low speed round bur. Haemostasis was obtained by applying pressure with moist cotton pellet with saline. Then the test materials was applied. after that, pulp stumps of all molars in each group will be dressed using Intermediate restorative material then the tooth will be restored with a preformed stainless steel crown
cone beam computed tomography (CBCT) assessmentRadiation
a post-operative CBCT image will be taken immediately after completing the procedure with fixed exposure parameters (120 Kv, 5mA, and 0.125mm voxel size) using the smallest field of view (8D, 8Hcm) also, after 12 months follow-up periods.
| Study group | Role | What they receive |
|---|---|---|
| group 1: Eggshell Powder | Experimental | 30 primary molars will be treated with Eggshell Powder freshly mixed with distilled water till it reaches a suitable consistency (1:1 ratio by volume) to cover pulp stumps Receives: Procedure: pulpotomy; Radiation: cone beam computed tomography (CBCT) assessment |
| group II: biodentine | Experimental | 30 primary molars will be treated with biodentine to cover pulp stumps Receives: Procedure: pulpotomy; Radiation: cone beam computed tomography (CBCT) assessment |
| group III: mineral tri-oxide aggregate (MTA) | Active comparator | 30 primary molars will be treated with MTA to cover pulp stumps Receives: Procedure: pulpotomy; Radiation: cone beam computed tomography (CBCT) assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
absence of pain
Measuring Method: Verbal Question to Patient /Parents Measuring Unite: score 0 for absence of pain and score 1 for presence of pain
Measured: up to 12 months
absence of fistula
Measuring Method: Visual examination by operator Measuring Unite: score 0 for absence of swelling and score 1 for presence of swelling
Measured: up to 12 months
Tenderness to percussion
Measuring Method: Percussion test Measuring Unite: Binary (+/-)
Measured: Up to 12 month
Furcation radiolucency
Measuring Method: cone beam computed tomography (CBCT) for assessment of radio-density of bone at the furcation area Measuring Unite: Binary (+/-)
Measured: 6 months
Furcation radiolucency
Measuring Method: cone beam computed tomography (CBCT) for assessment of radio-density of bone at the furcation area Measuring Unite: Binary (+/-)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2023
- Study start1 Apr 2023
- Primary completion30 Jan 2026
- Study completion10 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pulpitis ReversibleStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Shaban Mohamed El-desouky, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05812053
- Sponsor's protocol ID
- #R-PED-9-20-2
- Status last verified
- Aug 2026
- First submitted
- 21 Mar 2023
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Celik BN, Mutluay MS, Arikan V, Sari S. The evaluation of MTA and Biodentine as a pulpotomy materials for carious exposures in primary teeth. Clin Oral Investig. 2019 Feb;23(2):661-666. doi: 10.1007/s00784-018-2472-4. Epub 2018 May 10.
PubMed 29744721Nowicka A, Lipski M, Parafiniuk M, Sporniak-Tutak K, Lichota D, Kosierkiewicz A, Kaczmarek W, Buczkowska-Radlinska J. Response of human dental pulp capped with biodentine and mineral trioxide aggregate. J Endod. 2013 Jun;39(6):743-7. doi: 10.1016/j.joen.2013.01.005. Epub 2013 Apr 10.
PubMed 23683272Siva Rama Krishna D, Siddharthan A, Seshadri SK, Sampath Kumar TS. A novel route for synthesis of nanocrystalline hydroxyapatite from eggshell waste. J Mater Sci Mater Med. 2007 Sep;18(9):1735-43. doi: 10.1007/s10856-007-3069-7. Epub 2007 May 5.
PubMed 17483877Kattimani VS, Chakravarthi PS, Kanumuru NR, Subbarao VV, Sidharthan A, Kumar TS, Prasad LK. Eggshell derived hydroxyapatite as bone graft substitute in the healing of maxillary cystic bone defects: a preliminary report. J Int Oral Health. 2014 Jun;6(3):15-9. Epub 2014 Jun 26.
PubMed 25083027El-Desouky SS, Ghouraba RF, Kabbash IA, Metwally NM. Eggshell powder as a biomimetic alternative to biodentine in primary teeth pulpotomy: a comparative clinical and radiographic study. Sci Rep. 2026 Jul 14;16(1):22074. doi: 10.1038/s41598-026-61564-w.
PubMed 42448802
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Eggshell Powder Versus Biodentine in Primary Teeth Pulpotomy: Clinical And Radiographic Study
- ClinicalTrials.gov ID
- NCT05812053
- Acronym / sponsor ID
- #R-PED-9-20-2
- Conditions
- Pulpitis Reversible, Pulp Exposure, Dental
- Keywords
- Cone-beam computed tomography, egg shell powder, biodentine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- 10 Jul 2026 (actual)
- First posted
- 13 Apr 2023 (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.
To assess \& compare clinical \& radiographic effects of Eggshell Powder, Biodentine and MTA as pulpotomy agents in primary teeth.
Detailed description
Pulpotomy is the most widely accepted technique for treating primary teeth with deep carious lesion, pulp exposure during the operatory process or after a traumatic pulp exposure. Mineral trioxide aggregate (MTA) is one such material that has shown tremendous potential for regeneration. Biodentine™ (hydraulic silicate cement) is a novel dental material with high mechanical characteristics as well as superior biocompatibility and bioactive behaviour. Nowadays, chicken eggshell powder (CESP) (a natural calcium-rich source) is achieving wide acceptance in the medical and dental fields. To date, there is insufficient evidence to properly evaluate Eggshell Powder as a pulpotomy agent in primary teeth; thus, the current study aimed to assess and compare clinical and radiographical success of Eggshell Powder, Biodentine and MTA as pulpotomy agents in primary teeth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group 1: Eggshell Powder | Experimental | Procedure: pulpotomy, Radiation: cone beam computed tomography (CBCT) assessment30 primary molars will be treated with Eggshell Powder freshly mixed with distilled water till it reaches a suitable consistency (1:1 ratio by volume) to cover pulp stumps |
| group II: biodentine | Experimental | Procedure: pulpotomy, Radiation: cone beam computed tomography (CBCT) assessment30 primary molars will be treated with biodentine to cover pulp stumps |
| group III: mineral tri-oxide aggregate (MTA) | Active comparator | Procedure: pulpotomy, Radiation: cone beam computed tomography (CBCT) assessment30 primary molars will be treated with MTA to cover pulp stumps |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Restorable primary molars with deep carious lesions.
- Absence of gingival swelling or sinus tract.
- Absence of spontaneous pain
- Absence of pain on percussion.
- Absence of discontinuity of lamina dura
Key exclusion criteria (4 listed)
- presence of spontaneous pain
- presence of gingival swelling or sinus tract
- presence of internal or external root resorption
- pain on percussion.
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 |
|---|---|---|
| pulpotomyTeeth will be anesthetized then Rubber dam and high suction will be used in pulpotomy procedure. Cavity outline was performed by sterile #330 high speed bur using water spray. Caries was removed by large spoon excavator. When pulpal exposure occurred, the roof of pulp chamber removed by low speed round bur. Haemostasis was obtained by applying pressure with moist cotton pellet with saline. Then the test materials was applied. after that, pulp stumps of all molars in each group will be dressed using Intermediate restorative material then the tooth will be restored with a preformed stainless steel crown | Procedure or surgery | group 1: Eggshell Powder, group II: biodentine, group III: mineral tri-oxide aggregate (MTA) |
| cone beam computed tomography (CBCT) assessmenta post-operative CBCT image will be taken immediately after completing the procedure with fixed exposure parameters (120 Kv, 5mA, and 0.125mm voxel size) using the smallest field of view (8D, 8Hcm) also, after 12 months follow-up periods. | Radiation | group 1: Eggshell Powder, group II: biodentine, group III: mineral tri-oxide aggregate (MTA) |
Primary outcome
absence of pain
Time frame: up to 12 months
Measuring Method: Verbal Question to Patient /Parents Measuring Unite: score 0 for absence of pain and score 1 for presence of pain
absence of fistula
Time frame: up to 12 months
Measuring Method: Visual examination by operator Measuring Unite: score 0 for absence of swelling and score 1 for presence of swelling
Tenderness to percussion
Time frame: Up to 12 month
Measuring Method: Percussion test Measuring Unite: Binary (+/-)
Furcation radiolucency
Time frame: 6 months
Measuring Method: cone beam computed tomography (CBCT) for assessment of radio-density of bone at the furcation area Measuring Unite: Binary (+/-)
Furcation radiolucency
Time frame: 12 months
Measuring Method: cone beam computed tomography (CBCT) for assessment of radio-density of bone at the furcation area Measuring Unite: Binary (+/-)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Background: PubMed 29744721Celik BN, Mutluay MS, Arikan V, Sari S. The evaluation of MTA and Biodentine as a pulpotomy materials for carious exposures in primary teeth. Clin Oral Investig. 2019 Feb;23(2):661-666. doi: 10.1007/s00784-018-2472-4. Epub 2018 May 10.
- Background: PubMed 23683272Nowicka A, Lipski M, Parafiniuk M, Sporniak-Tutak K, Lichota D, Kosierkiewicz A, Kaczmarek W, Buczkowska-Radlinska J. Response of human dental pulp capped with biodentine and mineral trioxide aggregate. J Endod. 2013 Jun;39(6):743-7. doi: 10.1016/j.joen.2013.01.005. Epub 2013 Apr 10.
- Background: PubMed 17483877Siva Rama Krishna D, Siddharthan A, Seshadri SK, Sampath Kumar TS. A novel route for synthesis of nanocrystalline hydroxyapatite from eggshell waste. J Mater Sci Mater Med. 2007 Sep;18(9):1735-43. doi: 10.1007/s10856-007-3069-7. Epub 2007 May 5.
- Background: PubMed 25083027Kattimani VS, Chakravarthi PS, Kanumuru NR, Subbarao VV, Sidharthan A, Kumar TS, Prasad LK. Eggshell derived hydroxyapatite as bone graft substitute in the healing of maxillary cystic bone defects: a preliminary report. J Int Oral Health. 2014 Jun;6(3):15-9. Epub 2014 Jun 26.
- Derived from this study: PubMed 42448802El-Desouky SS, Ghouraba RF, Kabbash IA, Metwally NM. Eggshell powder as a biomimetic alternative to biodentine in primary teeth pulpotomy: a comparative clinical and radiographic study. Sci Rep. 2026 Jul 14;16(1):22074. doi: 10.1038/s41598-026-61564-w.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pulpotomy and cone beam computed tomography (CBCT) assessment in people with Pulpitis Reversible and Pulp Exposure, Dental, run by Tanta University at 1 site in Egypt.
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 8 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: finished, as of the sponsor's last update on 25 Aug 2026. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
absence of pain (time frame: up to 12 months). The study lists 5 primary outcomes in all. 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 NCT05812053, which also lists 5 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 25 Aug 2026.