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Pulpotomy in primary molars utilizing 2.25% sodium hypochlorite gel

Treatment outcomes of pulpotomy in primary molars utilizing 2.25% sodium hypochlorite gel as a medicament: a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN15908457
Enrollment
44
Registered
2024-07-22
Start date
2023-02-04
Completion date
Unknown
Last updated
2025-09-08

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

Conditions

Dental caries Oral Health

Interventions

Histological study: A randomized, triple-blinded, single-center, split-mouth, active-controlled clinical trial with two arms. Two pediatric experienced pediatric dentists (ICC >0.8) recruited 24 patie

Sponsors

Damascus University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Histological study: Cooperative patients aged 8-10 years requiring serial extraction and pulpotomy of first primary molars Clinical and radiographical study: Cooperative patients aged 5-10 years requiring pulpotomy of second primary molars

Exclusion criteria

Exclusion criteria: Histological study: Compromised patients or patients with signs and symptoms of pulp necrosis or spontaneous and/or nocturnal pain history in first primary molars Clinical and radiographical study: Compromised patients or patients with signs and symptoms of pulp necrosis or spontaneous and/or nocturnal pain history in second primary molars

Design outcomes

Primary

MeasureTime frame
The following primary outcomes will be measured using histology after 7, 30, and 90 days: 1. Odontoblastic integrity 2. Pulp tissue hemorrhage 3. Pulp fibrosis 4. Dentin bridge formation 5. Pulp calcification The following primary outcomes will be measured using clinical evaluation after 3, 6, and 12 months: 1. Spontaneous pain 2. Pain on percussion 3. Tooth mobility 4. Abscess 5. Fistula 6. Exfoliation of the treated tooth The following primary outcomes will be measured using radiographical evaluation after 3, 6, and 12 months: 1. Furcal radiolucency 2. Internal root resorption 3. External root resorption 4. Widening of the periodontal ligament 5. Canal obliteration 6. Dentin bridge formation

Secondary

MeasureTime frame
There are no secondary outcome measures

Countries

Syria

Contacts

Public ContactMawia Karkoutly
mawia95.karkoutly@damascusuniversity.edu.sy+963 (0)992 647 528

Outcome results

None listed

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