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Direct pulp capping in primary molars

Direct pulp capping (DPC) in primary molars using a combination of three antibiotics (3Mix-MP): a randomized parallel controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN13525994
Enrollment
36
Registered
2018-10-31
Start date
2017-08-15
Completion date
Unknown
Last updated
2021-02-16

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 Management of large carious lesions in primary teeth

Interventions

Participants are randomly allocated to either group A or group B using a simple randomisation technique. Group A receive direct pulp capping using 3Mix-MP, whereas group B receive dire

Sponsors

Tishreen University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Cooperative healthy children 2. Aged 5-11 years 3. Vital primary molars with large carious lesions that could be restored with composite 4. No history of spontaneous pain, pathological mobility, redness or swelling of the vestibule, draining sinus tracts, or sensitivity to vestibular palpation 5. Absence of internal or external root resorption or inter-radicular/apical radiolucency 6. Both children and their parents are able to attend a 12-month follow-up procedure

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Clinical success rate of the materials, with treatment considered to be a success if the following clinical signs are absent: 1. Spontaneous pain 2. Redness or soft tissue swelling 3. Mobility 4. Draining sinus tracts 5. Sensitivity to vestibular palpation Teeth will be assessed clinically at the baseline and 3, 6, 9 and 12 months post-treatment.

Secondary

MeasureTime frame
Radiographic success rate of the materials, with the treatment considered to be a success if the following radiographic signs are absent: 1. Internal or external pathological root resorption 2. Inter-radicular/periapical radiolucency Teeth will be assessed radiographically at the baseline and at 6 and 12 months post-treatment.

Countries

Syria

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 24, 2026