NCT05812053

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

March 21, 2023

Completed
11 days until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 13, 2023

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

December 26, 2025

Status Verified

December 1, 2025

Enrollment Period

2.8 years

First QC Date

March 21, 2023

Last Update Submit

December 18, 2025

Conditions

Keywords

Cone-beam computed tomographyegg shell powderbiodentine

Outcome Measures

Primary Outcomes (5)

  • 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

    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

    up to 12 months

  • Tenderness to percussion

    Measuring Method: Percussion test Measuring Unite: Binary (+/-)

    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 (+/-)

    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 (+/-)

    12 months

Study Arms (3)

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

Procedure: pulpotomyRadiation: cone beam computed tomography (CBCT) assessment

group II: biodentine

EXPERIMENTAL

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

Procedure: pulpotomyRadiation: 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

Procedure: pulpotomyRadiation: cone beam computed tomography (CBCT) assessment

Interventions

pulpotomyPROCEDURE

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

group 1: Eggshell Powdergroup II: biodentinegroup III: mineral tri-oxide aggregate (MTA)

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 1: Eggshell Powdergroup II: biodentinegroup III: mineral tri-oxide aggregate (MTA)

Eligibility Criteria

Age4 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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).

You may not qualify if:

  • presence of spontaneous pain
  • presence of gingival swelling or sinus tract
  • presence of internal or external root resorption
  • pain on percussion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University

Tanta, Gharbia Governorate, 6624033, Egypt

RECRUITING

Related Publications (4)

  • 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.

    PMID: 29744721BACKGROUND
  • 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.

    PMID: 23683272BACKGROUND
  • 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.

    PMID: 17483877BACKGROUND
  • 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.

    PMID: 25083027BACKGROUND

MeSH Terms

Conditions

Dental Pulp Exposure

Interventions

PulpotomyRestraint, Physical

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

EndodonticsDentistryBehavior ControlTherapeuticsImmobilizationInvestigative Techniques

Central Study Contacts

shaimaa eldesouky, lecturer

CONTACT

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
principal investigator

Study Record Dates

First Submitted

March 21, 2023

First Posted

April 13, 2023

Study Start

April 1, 2023

Primary Completion

January 1, 2026

Study Completion

February 1, 2026

Last Updated

December 26, 2025

Record last verified: 2025-12

Locations