Evaluating two treatments for infected primary molars in children
Clinical and Radiographic Evaluation of Zinc Oxide Modified 3Mixtatin Versus Zical Root Canal Sealer in Root Canal Treatment of Necrotic Primary Molars.(A Randomized Clinical Trial and in Vitro Study)
NA · Ain Shams University · NCT06752889
This study tests which of two different materials works better to treat infected baby teeth in kids aged 5 to 7.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 34 (estimated) |
| Ages | 5 Years to 7 Years |
| Sex | All |
| Sponsor | Ain Shams University (other) |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06752889 on ClinicalTrials.gov |
What this trial studies
This clinical trial compares the effectiveness of two root canal filling materials in treating necrotic primary molars in children aged 5-7. One group will receive a traditional zinc oxide eugenol-based sealer, while the other will receive a modified mixture containing antibiotics and simvastatin. The study aims to assess clinical and radiographic outcomes to determine which treatment better preserves the affected teeth and supports overall dental health. The trial will include children with specific eligibility criteria related to their dental condition and overall health.
Who should consider this trial
Good fit: Ideal candidates are children aged 5-7 with necrotic primary molars and no systemic diseases.
Not a fit: Patients with non-restorable molars or those with known allergies to antibiotics or anti-hyperlipidemia drugs may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the success rate of preserving primary molars, enhancing children's dental health and function.
How similar studies have performed: Previous studies have shown promising results with similar approaches using antibiotic mixtures in endodontics, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria 1. Children age range from 5-7 years. 2. Children free from any systemic diseases or genetic disorders. 3. Primary molar with necrotic pulp, with pain, gingival abscess, sinus openings. 4. Clinical mobility not exceeding grade two. 5. Radiographic evidence of non-perforating internal resorption, external resorption not exceeding 1\\3 of the root 6. Furcation or periapical radiolucency. Exclusion Criteria: 1. Non-restorable molars or beyond repair, for example: decay reaches to bifurcation, a hard gingival margin cannot be established or infection cannot be eradicated by other mean (Balaji, 2007). 2. Patient with known allergy to any type of antibiotics or anti-hyperlipidemia drugs. 3. Patient with facial cellulitis or lymphadenopathy 4. Lack of patient/parent compliance and cooperation. 5. Refusal of participation or failure to obtain an informed consent.
Where this trial is running
Cairo
- Ain Shams University — Cairo, Egypt (RECRUITING)
Study contacts
- Study coordinator: Mahmoud Sa'adoon, master
- Email: drmahmoudsa3doon@gmail.com
- Phone: 201115082428
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.
Conditions: Necrotic Pulp, Primary Teeth