Pulpotomy
Conditions
Keywords
TAMP BG, Biodentine, Regenerative materials, pulp therapy
Brief summary
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
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.
Interventions
DRUGTAMP bioglass
TAMP bioglass compared to Biodentine in the regeneration on pulpotomized primary teeth
DRUGBiodentine
TAMP bioglass compared to Biodentine in the regeneration on pulpotomized primary teeth
Sponsors
Alexandria University
Nourhan M.Aly
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
The operator will not be blinded to the treatment type. However, the participants, their care givers, the expert assessing the histologic and inflammatory changes and the statistician will be blinded to the treatment groups.
Intervention model description
Study group (assigned to TAMP bioglass), and Control group (assigned to Biodentine ™).
Eligibility
Sex/Gender
ALL
Age
5 Years to 9 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absence of clinical signs of pulp degeneration. | 1 month postoperatively | Teeth were considered clinically successful when they showed no signs of pain, sensitivity to percussion, swelling, fistula or pathologic mobility |
| Percentage of Teeth with no clinical signs of pulp degeneration. | 3 months postoperatively | Teeth were considered clinically successful when they showed no signs of pain, sensitivity to percussion, swelling, fistula or pathologic mobility |
| Percentage of Teeth with no radiographic signs of pulp degeneration. | 6 months postoperatively | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of teeth with radiographic evidence of dentin bridge formation | 6 months postoperatively | Assessed using digital radiographs |
| Dentin bridge formation using light microscopy | 6 weeks | 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. |
| Inflammatory response using light microscopy | 6 weeks | 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. |
| The Enzyme-Linked Immunosorbent Assay (ELISA) analysis. | 6 weeks | 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. |
Countries
Egypt
Outcome results
None listed