Comparative Evaluation of Eggshell Powder in Primary Teeth Pulpotomy

NCT ID: NCT05812053

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2026-02-28

Brief Summary

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To assess \& compare clinical \& radiographic effects of Eggshell Powder, Biodentine and MTA as pulpotomy agents in primary teeth.

Detailed Description

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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. Biodentineā„¢ (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

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Pulpitis Reversible Pulp Exposure, Dental

Keywords

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Cone-beam computed tomography egg shell powder biodentine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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group 1: Eggshell Powder

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

Group Type EXPERIMENTAL

pulpotomy

Intervention Type PROCEDURE

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) assessment

Intervention Type RADIATION

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.

group II: biodentine

30 primary molars will be treated with biodentine to cover pulp stumps

Group Type EXPERIMENTAL

pulpotomy

Intervention Type PROCEDURE

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) assessment

Intervention Type RADIATION

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.

group III: mineral tri-oxide aggregate (MTA)

30 primary molars will be treated with MTA to cover pulp stumps

Group Type ACTIVE_COMPARATOR

pulpotomy

Intervention Type PROCEDURE

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) assessment

Intervention Type RADIATION

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.

Interventions

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pulpotomy

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

Intervention Type PROCEDURE

cone beam computed tomography (CBCT) assessment

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.

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* 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).

Exclusion Criteria

* presence of spontaneous pain
* presence of gingival swelling or sinus tract
* presence of internal or external root resorption
* pain on percussion.
Minimum Eligible Age

4 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Shaimaa Shaban Mohamed El-desouky

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tanta University

Tanta, Gharbia Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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shaimaa eldesouky, lecturer

Role: CONTACT

Phone: +201008994242

Email: [email protected]

Facility Contacts

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Shaimaa eldesouky, PhD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 29744721 (View on PubMed)

Nowicka 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.

Reference Type BACKGROUND
PMID: 23683272 (View on PubMed)

Siva 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.

Reference Type BACKGROUND
PMID: 17483877 (View on PubMed)

Kattimani 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.

Reference Type BACKGROUND
PMID: 25083027 (View on PubMed)

Other Identifiers

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#R-PED-9-20-2

Identifier Type: -

Identifier Source: org_study_id