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Completed

NCT Number: NCT05530954

Direct Pulp Capping in Primary Molars

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.

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Key information

Conditions

Direct Pulp Capping

Age range

4 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Al Mansurah, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mineral Trioxide Aggregate (MTA)

Other

Materials for Vital Pulp Capping

Other names: BIO MTA, CERKAMED, Poland

Hard setting Calcium Hydroxide (Dycal)

Other

Materials for Vital Pulp Capping

Other names: Dycal, Promedica Urbical, Germany

Primary outcomes

  1. clinical success of direct pulp capping treatment after 3 months follow up

    Time frame: 3 months

    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.

  2. clinical success of direct pulp capping treatment after 6 months follow up

    Time frame: 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.

  3. clinical success of direct pulp capping treatment after 9 months follow up

    Time frame: 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.

  4. clinical success of direct pulp capping treatment after 12 months follow up

    Time frame: 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.

  5. radiographic success of direct pulp capping treatment after 3 months follow up

    Time frame: 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.

  6. radiographic success of direct pulp capping treatment after 6 months follow up

    Time frame: 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.

  7. radiographic success of direct pulp capping treatment after 9 months follow up

    Time frame: 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.

  8. radiographic success of direct pulp capping treatment after 12 months follow up

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Clinical Evaluation of Direct Pulp Capping in Primary Molars

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 7, 2022
Registry last updated
Sep 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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