Comparative Evaluation of Eggshell Powder in Primary Teeth Pulpotomy

Study Overview
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Brief Summary
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To assess & compare clinical & radiographic effects of Tea Tree Oil- Eggshell Powder and Biodentine 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. 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.

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

Conditions
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Pulp Exposure, Dental, Pulpitis Reversible

Intervention / Treatment
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* Procedure: pulpotomy
* Radiation: cone beam computed tomography (CBCT) assessment


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group 1: Tea Tree Oil- Eggshell Powder<br>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<br>* 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<br>Radiation: cone beam computed tomography (CBCT) assessment<br>* 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.<br>|
| Experimental: group II: biodentine<br>30 primary molars will be treated with biodentine to cover pulp stumps | Procedure: pulpotomy<br>* 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<br>Radiation: cone beam computed tomography (CBCT) assessment<br>* 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.<br>|
| Active Comparator: group III: mineral tri-oxide aggregate (MTA)<br>30 primary molars will be treated with MTA to cover pulp stumps | Procedure: pulpotomy<br>* 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<br>Radiation: cone beam computed tomography (CBCT) assessment<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cone-beam computed tomography, tea-tree oil, egg shell powder, biodentine