Clinical and Radiographic Comparison of Biodentine and Calcium Hydroxide Cement as Indirect Pulp Capping Agents
Comparison of pulpal response to Biodentine and Calcium hydroxide cement as an indirect pulp capping agent in adults with deep carious lesions
Islamabad Medical and Dental College
68 participants
Jul 14, 2022
Interventional
Conditions
Summary
This study assesses the efficacy of biodentine for the preservation of pulp vitality in deeply carious teeth. This study provides evidence that biodentine can be used as an alternative to calcium hydroxide cement (gold standard). The limitations of calcium hydroxide cement can be overcome with the use of biodentine due to its better mechanical strength, low solubility, and greater stimulation of the process of dentinogenesis. The results of this study will allow clinicians to take a realistic approach to the preservation of pulp vitality and reduce extensive invasive procedure such as extraction and root canal therapy.
Eligibility
Inclusion Criteria2
- a. Patients in which deep carious lesion penetrating three-quarters into the dentin as identified with bitewing radiographs using ICDAS Radiographic scoring system (RC 5)
- b. Any signs and symptoms of reversible pulpitis.
Exclusion Criteria6
- a. Mobile teeth.
- b. Tenderness to percussion.
- c. Teeth with fracture and internal resorption.
- d. Third molars.
- e. Pregnant women, in view of requirements for radiographs.
- f. Pulp exposure during removal of caries
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
The study will be conducted in compliance with CONSORT guidelines. 68 teeth (34 in each group calculated by WHO sample calculator) teeth in systemically healthy adult patients with carious permanent tooth identified by digital periapical radiographs using ICDAS radiographic scoring system (RC5) and absence of signs and symptoms of irreversible pulpitis, having positive pulp response to electrical and thermal stimulations will be included. On the contrary, teeth with mobility, fracture or internal resorption, sensitivity to percussion, third molars, pregnant women (considering requirements for radiographs) and teeth with pulp exposure during caries excavation will be excluded. After a brief explanation of the procedure, efficacy and safety of the materials, and possibilities of receiving either treatment option that is Biodentine (80.1% tricalcium silicate) or Dycal (calcium hydroxide), informed written consent will be obtained. Indirect pulp capping will be performed by a trained specialist . It involves removing soft, infected dentin with round diamond cutting burs in a high-speed handpiece followed by the removal of deeper caries using slow-speed handpiece. After caries removal, each tooth will be restored either by Biodentine or dycal (<1ml is required, depends on the cavity size and shape). The duration of indirect pulp capping and placement of restoration was approximately completed in 45minutes. Teeth restored with biodentine will receive definitive composite restoration 2 weeks after the treatment by 2mm reduction of biodentine, while teeth treated with dycal will receive GIC base and definitive composite filling in the same session. Composite filling will be performed in increments of 2mm that will be UV light cured for 20 seconds Post-operative follow-ups for each group, will be done at two, six and twelve weeks. Each follow up session will take around 30min. At two and six weeks, a clinical assessment will be performed, while radiographic assessment to evaluate widening of periodontal ligament space or presence of periapical radiolucency will be done at 12 weeks.
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12622001396718