Comparing melatonin and MTA for dental pulp therapy in children
Comparative Evaluation of Melatonin Versus Mineral Trioxide Aggregate on Vital Pulp Therapy in Young Permanent First Molars: An in Vivo Study
NA · Suez Canal University · NCT06372561
This study is testing whether melatonin works better than a common dental material called MTA for treating tooth decay in kids aged 6 to 8.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 6 Years to 8 Years |
| Sex | All |
| Sponsor | Suez Canal University (other) |
| Locations | 1 site (Ismailia) |
| Trial ID | NCT06372561 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of melatonin compared to mineral trioxide aggregate (MTA) in treating dental caries in young permanent first molars. It will involve 45 children aged 6 to 8 years, who will undergo apexogenesis procedures followed by the application of either MTA, melatonin, or a combination of both. The pulp response will be assessed clinically and radiographically at multiple follow-up intervals after treatment. This approach seeks to determine the best material for promoting healthy pulp regeneration in young patients.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy children aged 6 to 8 years with restorable mandibular permanent first molars and no signs of pulp degeneration.
Not a fit: Patients with internal or external root resorption, significant bone destruction, or deep carious lesions approaching the pulp will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve dental treatment outcomes for children with carious teeth by identifying a more effective pulp therapy material.
How similar studies have performed: While the use of MTA in pulp therapy is well-established, the specific comparison with melatonin is novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1- Apparently healthy and medically free children. 2- Their age ranges from 6-8 years. 3- Both boys and girls will be included. 4- Children should have mandibular permanent first molars with the following clinical and radiographic criteria. 4.1Restorable young permanent first molars. 4.2Absence of clinical evidence of pulp degeneration: * No history of spontaneous pain, history of night pain or pain that not relieved by analgesics. * No pain on percussion. * No mobility. * Absence of abscess, purulent sinus or soft tissue edema. * Bleeding should stop within 5 minutes after the amputated pulp stumps. Exclusion Criteria: * Internal root resorption. * External root resorption. * Inter radicular or periapical bone destruction (radiolucency) * A deep carious lesion radiologically that approaches the pulp
Where this trial is running
Ismailia
- Faculty of Medicine, Suez canal university — Ismailia, Egypt (RECRUITING)
Study contacts
- Principal investigator: Gihan GED El-Desouky, Professor — Professor
- Study coordinator: Mennatallah Hesham El shaabany, doctorate student
- Email: menna.hesham@dent.suez.edu.eg
- Phone: 01012906460
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: Dental Caries in Children, Vital Pulp Therapy