Success Rate of Three Capping Materials

Study Overview
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Brief Summary
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A randomized clinical trial was carried out on 72 second primary molars indicated for pulpotomy divided into three equal groups (n=24) . First group received Nanohydroxyapatite as a pulpotomy agent , second group received Mineral Trioxide Aggregate ( MTA) & the third received Formocresol pulpotomy. All pulpotomized teeth were finally restored with stainless steel crowns. Subjects were monitored clinically and radiographically at one, three , six & 12 months.

Detailed Description
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The study population included four to eight years old healthy and cooperative patients who presented at the Pediatric Dental Clinic, Faculty of Dentistry, Cairo University with mandibular second primary molars indicated for pulpotomy which met specific inclusion and exclusion criteria. Written consent was obtained from the parent/guardian after explaining the full details of the treatment procedure. Procedures: Preoperative periapical radiograph using periapical film size two Speed D Film , was taken for the molars considered for treatment. Radiographs should be of proper film density and contrast for proper radiographic diagnosis. The pulpotomy procedure was performed by the same operator. Local anesthesia was induced and rubber dam isolation was performed, followed by caries removal and deroofing of the pulp chamber using a #330 high-speed carbide bur mounted in a water-cooled high speed turbine. The coronal pulp tissue was amputated using a sterile sharp spoon excavator. The pulp chamber was irrigated with physiologic saline. Pulp homeostasis was achieved using a sterile wet cotton pellet applied for two to three min. In Group 1: Following the manufacturer's instructions, Nanohydroxyapatite was mixed with distilled water to homogeneous consistency then introduced into the pulp chamber and condensed properly against the pulp orifices. In Group 2: The MTA powder was mixed with sterile water in a 3:1 powder/water ratio according to the manufacturer's instructions to obtain a thick creamy paste, then placed on the floor of the pulp chamber using a messing gun and compacted against the pulp orifices with a condenser over a moist cotton pellet. Group 3: A cotton pellet with formocresol was placed on the pulp stumps then removed and ZO/E dressing was condensed against the pulp stumps. All Molars were finally restored with stainless steel crowns cemented with GI cement . An immediate postoperative radiograph using periapical film size two was taken. Clinical and radiographic evaluation: All treated patients were followed up at one, three , six & 12 months after the pulpotomy. The pulpotomized teeth were judged as clinically successful if they met the following criteria: Absence of sensitivity, pain, tenderness to percussion, abscess, fistula or tooth mobility. Radiographic success was defined if there were normal periodontal ligament space, absence of furcation or periapical radiolucency, absence of internal or external root resorption Statistical analysis: Data were collected, revised for completeness and logical consistency, tabulated, and statistically analyzed.

Official Title
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Success Rate of Three Capping Materials Used in Pulpotomy of Primary Molars: A Randomized Clinical Trial

Conditions
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Caries

Intervention / Treatment
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* Procedure: Nanohydroxyapatite Pulpotomy
* Procedure: MTA pulpotomy
* Procedure: Formocresol Pulpotomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Absence of tenderness to percussion. Absence of physiologic or pathologic tooth mobility. No clinical evidence of pulpal inflammation or degeneration, such as history of swelling or presence of sinus tract. Restorable teeth. Absence of radiographic evidence of internal or external root resorption, pulpal calcification, or osseous disease (periapical or furcation infection Exclusion Criteria: • Evidence of necrosis after access cavity preparation. Hemostasis could not be achieved within three min after direct contact with a wet cotton pellet, prior to material placement.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 8 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nanohydroxyapatite Pulpotomy<br>Biphasic calcium phosphate. Straumann BoneCeramic Regenerative Pulpotomy of 24 mandibular second primary molars using Nanohydroxyapatite In Group 1: 24 mandibular second primary molars Caries removal and deroofing of pulp chamber Following the manufacturer's instructions, Nanohydroxyapatite was mixed with distilled water to homogeneous consistency then introduced into the pulp chamber and condensed properly against the pulp orifices. All Molars were finally restored with stainless steel crowns cemented with GI cement . An immediate postoperative radiograph using periapical film size two was taken. Clinical and radiographic evaluation: All treated patients were followed up at one, three , six & 12 months after the pulpotomy | Procedure: Nanohydroxyapatite Pulpotomy<br>* Biphasic calcium phosphate 500-1000 Um Straumann BoneCeramic<br>|
| Active Comparator: MTA Pulpotomy<br>Angelus Grey MTA , Regenerative Pulpotomy Pulpotomy of 24 mandibular second primary molars using MTA Caries removal and deroofing of pulp chamber The MTA powder was mixed with sterile water in a 3:1 powder/water ratio according to the manufacturer's instructions to obtain a thick creamy paste, then placed on the floor of the pulp chamber using a messing gun and compacted against the pulp orifices with a condenser over a moist cotton pellet. All Molars were finally restored with stainless steel crowns cemented with GI cement . An immediate postoperative radiograph using periapical film size two was taken. Clinical and radiographic evaluation at one, three ,six & 12 months after pulpotomy. | Procedure: MTA pulpotomy<br>* Angleus grey MTA<br>|
| Active Comparator: Formocresl Pulpotomy<br>Buckley' s Formocresol , Fixation pulpotomy Pulpotomy of 24 mandibular second primary molars using Formocresol Caries removal and deroofing of pulp chamber A cotton pellet with formocresol was placed on the pulp stumps then removed and ZO/E dressing was condensed against the pulp stumps. All Molars were finally restored with stainless steel crowns cemented with GI cement . An immediate postoperative radiograph using periapical film size two was taken. Clinical and radiographic evaluation: All treated patients were followed up at one, three , six & 12 months after the pulpotomy for clinical and radiographic evaluation. Independently, two examiners evaluated the teeth clinically and radiographically. | Procedure: Formocresol Pulpotomy<br>* Buckley's Fromocresol. diluted full strength foromocresol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical success rate | abscence of all clinical signs and symptoms of failure | 12 Month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic success rate | Absence of any radiographic signs of failure | 12 Month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MTA, Pulpotomy, Formocresol, Nanohydroxyapatite