NCT05530954 - Direct Pulp Capping in Primary Molars | Crick

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

52

Conditions

Direct Pulp Capping

Interventions

Mineral trioxide aggregate (MTA)OTHER

Materials for Vital Pulp Capping

Hard setting Calcium Hydroxide (Dycal)OTHER

Materials for Vital Pulp Capping

Eligibility

Sex: ALLMin age: 4 YearsMax age: 7 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Outpatient clinic of the Department of Pediatric Dentistry, Faculty of Dentistry- Mansoura University

Al Mansurah, Egypt

Outcomes

Primary Outcomes

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.