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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
102
TAMP bioglass compared to Biodentine in the regeneration on pulpotomized primary teeth
TAMP bioglass compared to Biodentine in the regeneration on pulpotomized primary teeth
Faculty of Dentistry, Alexandria University
Alexandria, Egypt
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 6 months postoperatively
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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
Time frame: 12 months postoperatively
Percentage of teeth with radiographic evidence of dentin bridge formation
Assessed using digital radiographs
Time frame: 6 months postoperatively
Percentage of teeth with radiographic evidence of dentin bridge formation
Assessed using digital radiographs
Time frame: 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. 1. Incomplete hard tissue formation. 2. Thick hard tissue formation.
Time frame: 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. 1. Mild inflammatory cells (either acute or chronic). 2. Moderate inflammatory cell infiltration involving the cervical third of radicular pulp. 3. Severe inflammatory cell infiltration involving the coronal third of radicular pulp. B. Tissue disorganization: 0= Normal tissue beneath the site of pulp exposure. 1. Odontoblast-like cells, odontoblasts, and pulp tissue pattern disorganization. 2. General disorganization of the pulp tissue pattern. 3. Pulp necrosis.
Time frame: 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.
Time frame: 6 weeks