Clinical and Radiographic Assessment of Partial and Complete Pulpotomy in Primary Molars Using MTA

Study Overview
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Brief Summary
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that's comparison between partial and complete pulpotomy techniques in primary teeth

Official Title
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Clinical and Radiographic Assessment of Partial and Complete Pulpotomy in Primary Molars Using MTA : A Randomized Clinical Trial

Conditions
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Pulp Disease, Dental

Intervention / Treatment
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* Combination Product: MTA material


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Medically free children who will be able and cooperative in all steps of the study. - Asymptomatic primary molars with a deep carious lesion. - Vital pulp due to dental caries with no clinical sign of pulpal degeneration (spontaneous pain, fistula, mobility) prior to treatment. 3 - Preliminary radiographs indicating absence of pathologic internal or external root resorption, or any evidence of inter-radicular bone destruction. 4 - Absence of pre-operative pain or they will only have a short-term pain. 5 - No tenderness to percussion. 6-Age ranging 4-6 years. Exclusion Criteria: 1- Excessive bleeding during pulp amputation. 2 - Non vital teeth. 3 -History of spontaneous or prolonged pain. 4 - Swelling, tenderness, to percussion or palpation, or pathologic mobility. 5 - pre-operative radiographic pathology such as resorption (internal, external); periradicular or furcation radiolucency, or a widened periodontal ligament space. 6 - Parent or guardians who refuse participating in the study

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group A<br>placed with light pressure over the pulpal stumps (if hemorrhage control will not be achieve, tooth will be exclude ) 9.The pellet will be remove, and the pulp chamber filled with MTA. 10.The tooth will prepare and restore with a stainless steel crown cemented with glass ionomer cement | Combination Product: MTA material<br>* Partial pulpotomy is a procedure in which the inflamed tissue beneath an exposure is removed to a depth of 1 to 3 mm or deeper to reach healthy pulp tissue.<br>* Other names: partial pulpotomy procedure;|
| Active Comparator: group B<br>Pre-operative radiograph showing all roots and their apices. Local anesthesia will be administered and a rubber dam will take place ,that ensure good isolation of the treated teeth. Removal of caries Pulp chambers will access using a no.330 bur in a high-speed hand piece with water coolant. Removal of any remains of coronal pulp tissue with sharp sterile excavator or large bur in slow hand piece Pulp amputation will perform using a spoon excavator. Hemorrhage control will obtain within 5 minutes using sterile cotton pellets placed with light pressure over the pulpal stumps (if hemorrhage control will not be achieve, tooth will be exclude ) The pellet will be remove, and the pulp chamber will be filled with MTA. The tooth will prepare and restore with a stainless steel crown cemented with glass ionomer cement. The periapical radiographic will be taken at this baseline visit . | Combination Product: MTA material<br>* Partial pulpotomy is a procedure in which the inflamed tissue beneath an exposure is removed to a depth of 1 to 3 mm or deeper to reach healthy pulp tissue.<br>* Other names: partial pulpotomy procedure;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain | analog scale | 1 week | 
| postoperative pain | analog scale | 1 month | 
| postoperative pain | analog scale | 3 months | 
| postoperative pain | analog scale | 6 months | 
| swelling | clinical examination | 1 week | 
| swelling | clinical examination | 1 month | 
| swelling | clinical examination | 3 months | 
| swelling | clinical examination | 6 months | 
| mobility | clinical examination | 1 week | 
| mobility | clinical examination | 1 month | 
| mobility | clinical examination | 3 months | 
| mobility | clinical examination | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| root resorption | periapical radiograph | 1 week | 
| root resorption | periapical radiograph | 1 month | 
| root resorption | periapical radiograph | 3 months | 
| root resorption | periapical radiograph | 6 months | 
| Bone resorption | periapical radiograph | 1 week | 
| Bone resorption | periapical radiograph | 1 month | 
| Bone resorption | periapical radiograph | 3 months | 
| Bone resorption | periapical radiograph | 6 months |