Partial Versus Complete Pulpotomy Using Three Different Materials in Primary Molars: a Clinical Study

Study Overview
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Brief Summary
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The purposes of the study to compare partial pulpotomy versus complete pulpotomy in primary molars using three different materials (Formocresol, MTA, Theracal LC) . After 6, 9, 12 and 15 months follow up each case will be evaluated radiographically and clinically. the radiographic criteria to be evaluated are (radiolucency, resorption, widening in periodontal ligament space, Crypt involvement) and clinical criteria are ( pain, tenderness, fistula, abnormal mobility) upon these criteria some recommendations will be made on success and failure rate of each material and each technique.

Detailed Description
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In children, deep carious lesions represent the most common disease of primary teeth; 42% of children aged 2 to 11 have dental carious lesions in their primary teeth, with an average of 1.6 decayed teeth per child. The most important objective of pediatric dentistry treatment is the preservation of functional primary teeth until natural exfoliation. In the era of conservative dentistry we are now focusing on repair rather than replacement. Challenges regarding the best treatment modality in primary molars with deep carious lesions that are free of signs or symptoms have continued over the years. Based on a recent systematic review and a new American Academy of Pediatric Dentistry (AAPD) Guideline for vital pulp therapy in primary teeth, indirect pulp therapy (IPT), direct pulp cap (DPC), and pulpotomy are all viable options for treating the pulp in primary teeth with deep carious lesions. Partial pulpotomy (PP) was originally a means of preserving the remaining coronal and radicular pulp tissues in permanent teeth after a traumatic pulp exposure. In 1982, Cvek introduced this technique for permanent traumatized teeth with complicated crown fracture, which involved removing two mm of pulp and then dressing the non-inflamed pulp with calcium hydroxide. However, according to the new AAPD best practices recommendation, PP is also indicated in young permanent teeth with a carious pulp exposure in which pulpal bleeding can be controlled within several minutes. Calcium Hydroxide PP of primary molar teeth with deep carious lesions is used in studies conducted by Schroder and Trairatvorakul. Schroder. showed that the clinical-radiographic success rate of primary molar teeth one year after PP was 83 percent; they concluded that PP has the same favorable outcome as cervical formocresol pulpotomy (FP). If the pulp is diagnosed as normal or as having reversible pulpitis, a new regenerative material is recommended as the dressing material. In comparison with complete pulpotomy (i.e., removal of the entire pulp chamber), PP has several advantages; it causes limited injury to the pulp and limited loss of tooth substances, and this is important for pulpal healing and easier restoration. Pulpotomy is the pulp treatment most commonly used for primary teeth with a deep carious lesion approaching the pulp. With pulpotomy, a portion of the pulp is removed: the coronal pulp is removed and the radicular pulp is preserved. After treatment, the cavity is filled with a medicament followed by a final restoration. Formocresol pulpotomy (FCP) was developed in 1932 by Charles A. Sweet.. The original FCP was a three-appointment procedure which has been reduced to a one-appointment procedure; it is still the most common treatment for primary teeth with caries approaching the pulp. Studies have shown formocresol therapy to have a success rate between 70% and 90%.Histologic results have been variable in contrast to the high clinical success rate. Formocresol is still considered a gold standard by which all new modalities are compared. MTA is used in pulp capping whether indirect or directly it has the advantage of biocompatibility to the pulp tissues and stimulates the odontoblast for thicker secondary dentine formation without tunnel defects and formation of hydroxyapatite like material to seal the pulp tissues. Although it has slow setting time, discolor the tooth, relatively high cost compared to the gold stander calcium hydroxide. TheraCal light Cured (LC) is a single paste calcium silicate-based material promoted by the manufacturer for use as a pulp capping agent and as a protective liner for use with restorative materials, cement, or other base materials. The material might be very likable for clinicians because of its ease of handling. According to Alberto Danga in 2009 the cytotoxic effect of resin-based light-cured (Theracal) on human pulp tissue was least when compared to other materials. There is a lack of evidence in partial pulpotomy treating primary teeth. In this study a Randomized control trial will be performed to have an evidence based answer for treating primary teeth with partial pulpotomy.

Official Title
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Partial Versus Complete Pulpotomy Using Three Different Materials in Primary Molars: a Clinical Study

Conditions
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Decayed Primary Molars

Intervention / Treatment
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* Drug: Formocresol
* Drug: MTA
* Drug: TheraCal
* Procedure: pulpotomy
* Procedure: partial pulpotomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: No history of spontaneous or nocturnal pain. History of transient pain of sensitivity resulting from various stimuli: hot, cold and sweets. Patient who had a bilateral deep carious lesion at second primary molars. absence of tenderness to percussion absence of physiologic or pathologic tooth mobility Radiographic evidence of no internal or external resorption. There is not an intraradicular or periapical bone loss or widening of the periodontal ligament space. Exclusion Criteria: history of spontaneous or nocturnal pain. Patient who had a unilateral deep carious lesion. presence of tenderness to percussion presence of physiologic or pathologic tooth mobility Radiographic evidence of internal or external resorption. There is an intraradicular or periapical bone loss or widening of the periodontal ligament space.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 6 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: formocresol pulpotomy<br>gold standard arm which pulpotomy will be done with formocresol | Drug: Formocresol<br>* mixture of formalin, cresol and glycerine used for fixation of pulp tissues<br>Procedure: pulpotomy<br>* removal of the carious tooth structure and unroofing of the pulp chamber with a round carbide bur with high speed and water spray. The coronal pulp tissue will be then removed using a #4 carbide bur with slow speed and sharp spoon excavator.<br>|
| Active Comparator: formocresol partial pulpotomy<br>partial pulpotomy will be done with formocresol | Drug: Formocresol<br>* mixture of formalin, cresol and glycerine used for fixation of pulp tissues<br>Procedure: partial pulpotomy<br>* complete removal of caries till exposure occurs. The exposed surface of the pulp will be gently removed using a sterile round diamond bur and a high-speed, water-cooled handpiece with light hand pressure. The removal of the pulp did not exceed approximately two mm.<br>|
| Active Comparator: MTA pulpotomy<br>in this group complete pulpotomy will be done with MTA | Drug: MTA<br>* material used for pulp regeneration, direct and indirect pulp capping<br>* Other names: Mineral trioxide aggregate;Procedure: pulpotomy<br>* removal of the carious tooth structure and unroofing of the pulp chamber with a round carbide bur with high speed and water spray. The coronal pulp tissue will be then removed using a #4 carbide bur with slow speed and sharp spoon excavator.<br>|
| Active Comparator: MTA partial pulpotomy<br>in this study group partial pulpotomy will be done with MTA | Drug: MTA<br>* material used for pulp regeneration, direct and indirect pulp capping<br>* Other names: Mineral trioxide aggregate;Procedure: partial pulpotomy<br>* complete removal of caries till exposure occurs. The exposed surface of the pulp will be gently removed using a sterile round diamond bur and a high-speed, water-cooled handpiece with light hand pressure. The removal of the pulp did not exceed approximately two mm.<br>|
| Active Comparator: pulpotomy with Theracal LC<br>in this study group complete pulpotomy will be done with Theracal LC | Drug: TheraCal<br>* light cured resin modified calcium silicate filled liner designed for use in direct and indirect pulp capping<br>Procedure: pulpotomy<br>* removal of the carious tooth structure and unroofing of the pulp chamber with a round carbide bur with high speed and water spray. The coronal pulp tissue will be then removed using a #4 carbide bur with slow speed and sharp spoon excavator.<br>|
| Active Comparator: partial pulpotomy with Theracal LC<br>in this study group partial pulpotomy technique will be done with Theracal LC | Drug: TheraCal<br>* light cured resin modified calcium silicate filled liner designed for use in direct and indirect pulp capping<br>Procedure: partial pulpotomy<br>* complete removal of caries till exposure occurs. The exposed surface of the pulp will be gently removed using a sterile round diamond bur and a high-speed, water-cooled handpiece with light hand pressure. The removal of the pulp did not exceed approximately two mm.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post operative pain | numerical/visual analogue scale 0 no pain 10 worst possible pain | 15 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| radiolucency | measuring tool is periapical xray | 15 months | 
| fistula | visual inspection | 15 months | 
| tooth mobility | clinical method of assessing tooth mobility 0 no mobility 3 mobility more than 2 mm bucco-lingualy | 15 months | 
| tenderness | percussion test with numerical/visual analogue scale 0 no pain 10 worst possible pain | 15 months | 
| root resorption | periapical xray | 15 months | 
| widening in periodontal ligament space | periapical xray | 15 months | 
| permanent tooth crypt involvement | periapical xray | 15 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Partial Pulpotomy, pulpotomy, MTA, Theracal, Formocresol