Regenerative Ability of TAMP BG and BD in Pulpotomized Primary Teeth

Study Overview
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Brief Summary
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The aim of this study was to assess clinically, radiographically, and histologically the regenerative ability of Tailored Amorphous Mulioporous (TAMP-BG) bioglass in comparison to Biodentine™ (BD) in pulpotomized primary teeth.

Detailed Description
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The study was a parallel design, randomized controlled clinical trial It was conducted in the out-patient clinic of the Pediatric Dentistry and Dental public health department after obtaining the guardians consent. The sample size was calculated to be 35 teeth per group. The teeth were randomly and equally assigned to either BD or TAMP-BG groups.The treatment follow-up was scheduled at 1, 3, 6, 9 and 12 months. The study was terminated for ethical considerations after showing significant clinical failure in the TAMP-BG group and after performing interim analysis.

Official Title
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Comparison of the Regenerative Ability of Tailored Amorphous Multiporous Bioglass and Biodentine in Pulpotomized Primary Teeth

Conditions
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Pulpotomy

Intervention / Treatment
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* Drug: TAMP bioglass
* Drug: Biodentine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children free of any systemic disease or special health care needs. Children not receiving any anti-inflammatory medication. Cooperative children (positive/ definitely positive) according to Frankl's behavior rating scale. Restorable teeth. Teeth with vital carious pulp exposure that will bleed upon entering the pulp chamber and not requiring more than 5 minutes to achieve hemostasis after coronal pulp amputation. Teeth indicated for extraction for orthodontic purposes with the previously mentioned criteria (required for a subgroup for assessment of histological and inflammatory response outcomes). Exclusion Criteria: Teeth with clinical or radiographic signs of pulp degeneration.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 9 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
Interventional Model Description: Study group (assigned to TAMP bioglass), and Control group (assigned to Biodentine ™).
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAMP bioglass<br>Tailored amorphous multiporous bioglass (TAMP-BG) of 70% SiO2 / 30% CaO was prepared according to Wang et al. (2011, 2013) in the tissue engineering lab, Faculty of Dentistry, Alexandria University as follows: Scaffolds were grounded to 180- to 300-μm particle size and sterilized at 180°C for 2 hours. The resulting powder was mixed with distilled water to obtain a putty like consistency that was carried to the pulp chamber and condensed lightly on the pulp stumps. | Drug: TAMP bioglass<br>* TAMP bioglass compared to Biodentine in the regeneration on pulpotomized primary teeth<br>* Other names: 70S30C bioglass;|
| Active Comparator: Biodentine ™<br>Biodentine ™ (BD) pre-dosed capsule were gently tapped on a hard surface to diffuse the powder. Five drops of the liquid from the single dose dispenser were poured into the capsule and mixed for 30 seconds at 4,200 rpm in an amalgamator according to manufacturer's instructions to obtain putty- like consistency. (Powder-liquid system). It was then be carried to the pulp chamber and condensed lightly on the pulp stumps. Final restoration was applied after 12 minutes, allowing Biodentine ™ to set. | Drug: Biodentine<br>* TAMP bioglass compared to Biodentine in the regeneration on pulpotomized primary teeth<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence of clinical signs of pulp degeneration. | Teeth were considered clinically successful when they showed no signs of pain, sensitivity to percussion, swelling, fistula or pathologic mobility | 1 month postoperatively | 
| Percentage of Teeth with no clinical signs of pulp degeneration. | Teeth were considered clinically successful when they showed no signs of pain, sensitivity to percussion, swelling, fistula or pathologic mobility | 3 months postoperatively | 
| Percentage of Teeth with no clinical signs of pulp degeneration. | Teeth were considered clinically successful when they showed no signs of pain, sensitivity to percussion, swelling, fistula or pathologic mobility | 6 months postoperatively | 
| Percentage of Teeth with no clinical signs of pulp degeneration. | Teeth were considered clinically successful when they showed no signs of pain, sensitivity to percussion, swelling, fistula or pathologic mobility | 9 months postoperatively | 
| Percentage of Teeth with no clinical signs of pulp degeneration. | Teeth were considered clinically successful when they showed no signs of pain, sensitivity to percussion, swelling, fistula or pathologic mobility | 12 months postoperatively | 
| Percentage of Teeth with no radiographic signs of pulp degeneration. | Digital postoperative periapical radiographs were obtained and assessed for signs of pulp degeneration. Teeth were considered radiographically successful when they showed no periapical or interradicular radiolucency, abnormal root resorption or periodontal ligament space widening | 6 months postoperatively | 
| Percentage of Teeth with no radiographic signs of pulp degeneration. | Digital postoperative periapical radiographs were obtained and assessed for signs of pulp degeneration. Teeth were considered radiographically successful when they showed no periapical or interradicular radiolucency, abnormal root resorption or periodontal ligament space widening | 12 months postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of teeth with radiographic evidence of dentin bridge formation | Assessed using digital radiographs | 6 months postoperatively | 
| Percentage of teeth with radiographic evidence of dentin bridge formation | Assessed using digital radiographs | 12 months postoperatively | 
| Dentin bridge formation using light microscopy | After tooth extraction, histological assessment will be done according to Horsted et al's (1981) and Shayegan et al's (2012) modified criteria. 0= No hard tissue formation. Incomplete hard tissue formation. Thick hard tissue formation. | 6 weeks | 
| Inflammatory response using light microscopy | After tooth extraction, histological assessment will be done according to Horsted et al's (1981) and Shayegan et al's (2012) modified criteria. A. Inflammatory cell response: 0= None or a few scattered inflammatory cells beneath the site of pulp exposure. Mild inflammatory cells (either acute or chronic). Moderate inflammatory cell infiltration involving the cervical third of radicular pulp. Severe inflammatory cell infiltration involving the coronal third of radicular pulp. B. Tissue disorganization: 0= Normal tissue beneath the site of pulp exposure. Odontoblast-like cells, odontoblasts, and pulp tissue pattern disorganization. General disorganization of the pulp tissue pattern. Pulp necrosis. | 6 weeks | 
| The Enzyme-Linked Immunosorbent Assay (ELISA) analysis. | After extraction, the tooth will be sectioned under copious water cooling and all remaining pulp tissue will be harvested gently from the radicular portion and stored until the time of assaying. For the ELISA assaying, the frozen pulp samples will be thawed for 15 minutes, and crushed with a glass rod in the eppendorf tube to elute the cytokines from the pulp tissue. IL-8 and IL-10 will be measured using ElISA Kits according to the instructions supplied with the kit and the ratio of IL-8/IL-10 will be taken as an indicator of pulpal inflammation. Cytokines' concentration will be calculated according to the weight of the pulp tissue. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TAMP BG, Biodentine, Regenerative materials, pulp therapy