Comparative Evaluation of Eggshell Powder in Primary Teeth Pulpotomy

December 5, 2023 updated by: Shaimaa Shaban Mohamed El-desouky, Tanta University

Comparative Evaluation of Eggshell Powder Versus Biodentine in Primary Teeth Pulpotomy: Clinical And Radiographic Study

To assess & compare clinical & radiographic effects of Tea Tree Oil- Eggshell Powder and Biodentine as pulpotomy agents in primary teeth.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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. Tea tree oil is the essential oil extracted from the Australian native Melaleuca alternifolia or the tea tree. To date, there is insufficient evidence to properly evaluate Tea Tree Oil- Eggshell Powder as a pulpotomy agent in primary teeth; thus, the current study aimed to assess and compare clinical and radiographical success of Tea Tree Oil- Eggshell Powder and Biodentine as pulpotomy agents in primary teeth.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: group 1: Tea Tree Oil- Eggshell Powder
30 primary molars will be treated with Eggshell Powder freshly mixed with Tea Tree Oil till reach suitable consistency (1:1 ratio by volume) to cover pulp stumps
Procedure: 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
Radiation: 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 6 and 12 months follow-up periods.
Experimental: group II: biodentine
30 primary molars will be treated with biodentine to cover pulp stumps
Procedure: 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
Radiation: 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 6 and 12 months follow-up periods.
Active Comparator: group III: mineral tri-oxide aggregate (MTA)
30 primary molars will be treated with MTA to cover pulp stumps
Procedure: 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
Radiation: 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 6 and 12 months follow-up periods.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 12 months
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
up to 12 months
Tenderness to percussion
Time Frame: Up to 12 month
Measuring Method: Percussion test Measuring Unite: Binary (+/-)
Up to 12 month
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 (+/-)
6 months
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 (+/-)
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

March 21, 2023

First Submitted That Met QC Criteria

April 1, 2023

First Posted (Actual)

April 13, 2023

Study Record Updates

Last Update Posted (Estimated)

December 7, 2023

Last Update Submitted That Met QC Criteria

December 5, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #R-PED-9-20-2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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