ZOE versus Metapex with rotary or manual filing in children's primary molars
Clinical and Radiographic Evaluation of Zinc Oxide Eugenol (ZOE) and Iodoform-Calcium Hydroxide (Metapex) as Filling Materials in Primary Molar Root Canals Prepared by Rotary and Manual Files: (Randomized Control Trial Study)
This test will compare Zinc Oxide Eugenol (ZOE) and Metapex, each used with rotary or manual filing, to see which helps infected baby molars heal better in children aged 5–8.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 5 Years to 8 Years |
| Sex | All |
| Sponsor | October University for Modern Sciences and Arts Academic / other |
| Locations | 1 site (Giza, Giza Governorate) |
| Trial ID | NCT07395401 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial enrolls 44 restorable primary molars from cooperative children aged 5–8 that require pulpectomy and randomizes teeth into four groups combining two instrumentation methods (rotary or manual) with two filling materials (ZOE or Metapex). Clinical outcomes (pain, mobility, and sensitivity) will be measured with standardized scales, and radiographic healing, root resorption, and bone density will be evaluated by CBCT at baseline, 6 months, and 12 months. The trial compares how well each obturation material and preparation technique promotes healing, adapts to the canal, and resorbs compatibly with normal tooth exfoliation. Results aim to inform which material and method yield the best short- to mid-term outcomes for primary molar pulpectomy.
Who should consider this trial
Good fit: Cooperative, otherwise healthy children aged 5–8 with restorable primary molars indicated for pulpectomy and without significant external root resorption are ideal candidates.
Not a fit: Uncooperative children, those with systemic medical illnesses, or teeth with more than two-thirds root resorption are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the findings could help dentists choose the filling material and filing method that better preserves infected primary molars and reduces premature tooth loss.
How similar studies have performed: ZOE has long been a standard and Metapex plus rotary NiTi preparation have shown promising results in prior work, but direct comparisons have produced mixed, context-dependent findings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Apparently healthy cooperative children indicated for partial pulpectomy. 2. Restorable primary molars. 3. No mobility, or external pathological root resorption. Exclusion Criteria: 1. Uncooperative children. 2. Children with systemic medical illness. 3. More than 2/3 of root resorbed.
Where this trial is running
Giza, Giza Governorate
- Faculty of Dentistry, MSA University — Giza, Giza Governorate, Egypt (Recruiting)
Study contacts
- Study coordinator: Nanis Nasser, bachelor degree of dentistry
- Email: nanis.nasser1@msa.edu.eg
- Phone: +201152791000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.