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Direct pulp capping in primary molars: a feasibility study

Direct pulp capping (DPC) in primary molars using three antibiotics combination 3mix-mp: a randomized controlled pilot trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN10402878
Enrollment
20
Registered
2018-10-25
Start date
2016-08-20
Completion date
Unknown
Last updated
2023-11-28

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

Conditions

Management of large carious lesions in primary teeth Oral Health Dental caries

Interventions

Twenty molars in eight cooperative healthy children were randomly allocated into two groups using a simple randomization process. In both groups, teeth were anesthetized and isolated with a rubber dam
consequently, polishing was performed using silicone polishers. The participants were asked to attend follow-up examination, and were clinically evaluated at 3 and 6 months post-treatment and were ev

Sponsors

Tishreen University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Cooperative healthy children 2. Vital primary molars with large carious lesions that could be restored with composite 3. No history of spontaneous pain, pathologic mobility, redness or swelling of the vestibule, draining sinus tracts, or sensitivity to vestibular palpation 4. Absence of internal or external root resorption or inter-radicular/apical radiolucency 5. Both children and their parents had to be able to attend a 6-month follow-up procedure

Exclusion criteria

Exclusion criteria: Any clinical or radiographic signs indicating non-vital teeth

Design outcomes

Primary

MeasureTime frame
Feasibility, estimated using the following measurements: 1. Proportion of eligible children among those examined, calculated after completion of the assigned number of participants 2. Proportion of children who completed the 6-month follow-up among those randomized, calculated after completion of the assigned period

Secondary

MeasureTime frame
Success rates of the materials, which will be used to calculate the sample size for the definitive randomized controlled trial. Criteria used: absence/presence of clinical and radiographic signs, proportions calculated using simple formulas. Measured at the end of the treatment session as a baseline; the participants were clinically evaluated at 3 and 6 months post-treatment and evaluated radiographically after 6 months

Countries

Syria

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026