Skip to content

Direct Pulp Capping in Primary Molars

Clinical Evaluation of Direct Pulp Capping in Primary Molars

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05530954
Enrollment
52
Registered
2022-09-07
Start date
2022-01-01
Completion date
2023-06-06
Last updated
2023-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Direct Pulp Capping

Keywords

primary dentition, MTA, Dycal, bioactive material, deciduous dentition, Direct pulp capping

Brief 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.

Detailed 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.

Interventions

Materials for Vital Pulp Capping

OTHERHard setting Calcium Hydroxide (Dycal)

Materials for Vital Pulp Capping

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

capping material used

Intervention model 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. All patients were recalled and their treated molars were evaluated clinically and radiographically at 3months, 6months, 9months ,12months follow up periods. 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

Eligibility

Sex/Gender
ALL
Age
4 Years to 7 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
clinical success of direct pulp capping treatment after 3 months follow up3 monthsPresence 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.
clinical success of direct pulp capping treatment after 6 months follow up6 months follow upPresence 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.
clinical success of direct pulp capping treatment after 9 months follow up9 months follow upPresence 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.
clinical success of direct pulp capping treatment after 12 months follow up12 months follow upPresence 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.
radiographic success of direct pulp capping treatment after 3 months follow up3 months follow upthe 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.
radiographic success of direct pulp capping treatment after 6 months follow up6 months follow upthe 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.
radiographic success of direct pulp capping treatment after 9 months follow up9 months follow upthe 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.
radiographic success of direct pulp capping treatment after 12 months follow up12 months follow upthe 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026