Direct Pulp Capping in Primary Molars

Direct Pulp Capping Clinical Trial

Official title:

Clinical Evaluation of Direct Pulp Capping in Primary Molars

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05530954
• Other study ID #: DPC in primary molars
• Status: Completed
• Phase: Phase 3
• Start date: January 1, 2022
• Est. completion date: June 6, 2023

Study information

• Verified date: September 2023
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: June 6, 2023
• Est. primary completion date: May 27, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 7 Years

Eligibility

Inclusion Criteria:

• Cooperative child and compliant parent.
• Complete physical and mental health.
• Children who are known to be healthy and free from systemic diseases.
• Primary molars with deep carious lesions leading to pathological exposure but with no signs or symptoms of irreversible pulpitis or necrosis such as spontaneous pain, tenderness to percussion, abscess, fistula, periodontal tissue swelling, or abnormal tooth mobility.

Exclusion Criteria:

• A deep carious lesion in close proximity to the pulp with an intact lamina dura.
• Absence of widening of periodontal membrane space or radiolucency at the furcation and periapical region.
• Absence of pulpal calcifications, obliteration of the pulp and root canal, or internal/external root resorption.

Related Conditions & MeSH terms

• Direct Pulp Capping

Intervention

Other:
• Mineral trioxide aggregate (MTA)
Materials for Vital Pulp Capping
• Hard setting Calcium Hydroxide (Dycal)
Materials for Vital Pulp Capping

Locations

Country	Name	City	State
Egypt	Outpatient clinic of the Department of Pediatric Dentistry, Faculty of Dentistry- Mansoura University	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

Caicedo R, Abbott PV, Alongi DJ, Alarcon MY. Clinical, radiographic and histological analysis of the effects of mineral trioxide aggregate used in direct pulp capping and pulpotomies of primary teeth. Aust Dent J. 2006 Dec;51(4):297-305. doi: 10.1111/j.18 — View Citation

de Lourdes Rodrigues Accorinte M, Reis A, Dourado Loguercio A, Cavalcanti de Araujo V, Muench A. Influence of rubber dam isolation on human pulp responses after capping with calcium hydroxide and an adhesive system. Quintessence Int. 2006 Mar;37(3):205-12 — View Citation

Faraco IM Jr, Holland R. Response of the pulp of dogs to capping with mineral trioxide aggregate or a calcium hydroxide cement. Dent Traumatol. 2001 Aug;17(4):163-6. doi: 10.1034/j.1600-9657.2001.170405.x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months
Primary	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.	6 months follow up
Primary	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.	9 months follow up
Primary	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.	12 months follow up
Primary	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.	3 months follow up
Primary	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.	6 months follow up
Primary	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.	9 months follow up
Primary	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.	12 months follow up

External Links

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