A Phase 3 interventional study of Mineral trioxide aggregate (MTA) and Hard setting Calcium Hydroxide (Dycal) in Direct Pulp Capping, sponsored by Mansoura University. Completed at 1 site in Egypt. Open to participants aged 4 Years to 7 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-26.
Sponsored by Mansoura University · Phase 3, Interventional, and Treatment
The purpose of this study is to Assess the effect of MTA and hard setting Calcium Hydroxide (Dycal) on the clinical and radiographic outcome of direct pulp capping in primary molars and evaluate overall success rate of direct pulp capping in primary molars.
After informed consent, baseline clinical and radiographic assessment will be obtained and recorded in patient examination sheet.
Participants who met the inclusion criteria were randomly allocated to two groups (n = 26/group, N = 52 in total) according to the capping martials using the envelope randomization method.
2 study groups according to capping material that will be used (Dycal or MTA) and each group will be divided to 2 subgroups according to site of exposure axial or pulpal.
All patients were recalled and their treated molars were evaluated clinically and radiographically at 3months, 6months, 9months ,12months follow up periods.
Mansoura University is the lead sponsor of 1,115 studies on the registry; 184 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
* where the pulp tissue is exposed during final caries removal, hemostasis will be achieved by cavity irrigation with sterile saline solution for up to 4 minutes till control of bleeding * Teeth with pulp exposure less than 1mm in diameter surrounded by sound dentin will be candidates for direct pulp capping * Following the removal of the saline, the exposed pulp will be irrigated with 17% EDTA solution (Prevest Direct, India) for 1 minute * According to site of exposure, the groups will be further subdivided into Group A (n=13) with exposure in pulpal floor and Group B (n=13) with exposure in axial wall of the cavity. * Exposed pulp will be covered with fast set MTA paste after cavity dryness with sterile cotton pellet then the tooth will be restored with Self-cured glass ionomer restorative material (SDI Riva self-cure, Australia) and tooth will be covered by stainless steel crown
Other: Mineral trioxide aggregate (MTA)
* where the pulp tissue is exposed during final caries removal, hemostasis will be achieved by cavity irrigation with sterile saline solution for up to 4 minutes till control of bleeding * Teeth with pulp exposure less than 1mm in diameter surrounded by sound dentin will be candidates for direct pulp capping * Following the removal of the saline, the exposed pulp will be irrigated with 17% EDTA solution (Prevest Direct, India) for 1 minute * According to site of exposure, the groups will be further subdivided into Group A (n=13) with exposure in pulpal floor and Group B (n=13) with exposure in axial wall of the cavity. * Exposed pulp will be covered with Dycal paste after cavity dryness with sterile cotton pellet then the tooth will be restored with Self-cured glass ionomer restorative material (SDI Riva self-cure, Australia) and tooth will be covered by stainless steel crown
Other: Hard setting Calcium Hydroxide (Dycal)
Materials for Vital Pulp Capping
Also known as: BIO MTA, CERKAMED, Poland
Materials for Vital Pulp Capping
Also known as: Dycal, Promedica Urbical, Germany
clinical success of direct pulp capping treatment after 3 months follow up
Presence of any of these clinical findings will be considered failure: pain on mastication or spontaneous pain, as reported by the patient, without clinical evidence of plaque retention around the crown margin denoting bad oral hygiene. pain on percussion on clinical examination . non-physiologic mobility. fistula or sinus tract.
Time frame: 3 months
clinical success of direct pulp capping treatment after 6 months follow up
Presence of any of these clinical findings will be considered failure: pain on mastication or spontaneous pain, as reported by the patient, without clinical evidence of plaque retention around the crown margin denoting bad oral hygiene. pain on percussion on clinical examination . non-physiologic mobility. fistula or sinus tract.
Time frame: 6 months follow up
clinical success of direct pulp capping treatment after 9 months follow up
Presence of any of these clinical findings will be considered failure: pain on mastication or spontaneous pain, as reported by the patient, without clinical evidence of plaque retention around the crown margin denoting bad oral hygiene. pain on percussion on clinical examination . non-physiologic mobility. fistula or sinus tract.
Time frame: 9 months follow up
clinical success of direct pulp capping treatment after 12 months follow up
Presence of any of these clinical findings will be considered failure: pain on mastication or spontaneous pain, as reported by the patient, without clinical evidence of plaque retention around the crown margin denoting bad oral hygiene. pain on percussion on clinical examination . non-physiologic mobility. fistula or sinus tract.
Time frame: 12 months follow up
radiographic success of direct pulp capping treatment after 3 months follow up
the absence of the following radiographic findings indicate the success of capping material in pulp therapy: * pathological internal or external root resorption. * PDL widening. * inter-radicular radiolucency formation postoperatively. * periapical radiolucency formation postoperatively.
Time frame: 3 months follow up
radiographic success of direct pulp capping treatment after 6 months follow up
the absence of the following radiographic findings indicate the success of capping material in pulp therapy: * pathological internal or external root resorption. * PDL widening. * inter-radicular radiolucency formation postoperatively. * periapical radiolucency formation postoperatively.
Time frame: 6 months follow up
radiographic success of direct pulp capping treatment after 9 months follow up
the absence of the following radiographic findings indicate the success of capping material in pulp therapy: * pathological internal or external root resorption. * PDL widening. * inter-radicular radiolucency formation postoperatively. * periapical radiolucency formation postoperatively.
Time frame: 9 months follow up
radiographic success of direct pulp capping treatment after 12 months follow up
the absence of the following radiographic findings indicate the success of capping material in pulp therapy: * pathological internal or external root resorption. * PDL widening. * inter-radicular radiolucency formation postoperatively. * periapical radiolucency formation postoperatively.
Time frame: 12 months follow up
Plan to share: No
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