Status:
COMPLETED
Preformed Pediatric Crown Zirconia Versus Preformed Pediatric Metal Crown
Lead Sponsor:
Centre Hospitalier Universitaire de Nice
Conditions:
Tooth Decay
Eligibility:
All Genders
4-18 years
Phase:
NA
Brief Summary
Preformed metal pediatric crowns (PPCm) are currently considered the best method of restoring Primary molars affected by severe carious lesions compared to restorations made with various restorative m...
Eligibility Criteria
Inclusion
- Children of at least 4 years of good general health (ASAI or II),
- Child with at least two temporary molars of the same type, 1st or 2nd molar, contralateral (fractional mouth), meeting the following criteria:
- The two temporary molars are affected by a cavitary carious lesion or a hypoplastic defect of at least 2 faces,
- the two temporary molars of the pair (54-64, 55-65, 74-84 or 75-85), should or should not be subjected to pulpotomy prior to the realization of the CPP,
- the two molars must have an antagonistic tooth.
- Consent of parents (legal guardians) and child,
- Child and parents (legal guardians) speaking French,
- Child covered by his parents' social security cover,
- Child cooperating in the vigilant or sedated state (cooperation evaluated with a Venham score 0, 1, 2).
Exclusion
- Child who does not cooperate in care under vigil or under conscious sedation, who must therefore be treated under general anesthesia.
- Child allergic to local anesthetics, chromium or nickel. Exclusion dental criteria
- Primary molar whose physiological exfoliation will appear within 24 months or pimary molar with a root resorption of more than a third of the radicular length.
- Severely decayed PM prohibiting the retention and the sealing of the restoration.
- Primary molar with exposed cement or with evidence of swelling in the surrounding tissues
- Molar with spontaneous pain.
- Primary molar in infraclusion.
- Primary molar whose radiographic examination reveals a widening of the desmodontal space, the presence of radiolucent image on the root furcation and/or apices, internal or external resorption
Key Trial Info
Start Date :
September 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 22 2023
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT03296709
Start Date
September 10 2018
End Date
March 22 2023
Last Update
November 18 2023
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
CHRU Lille
Lille, France, 59000
2
CHU de Nantes
Nantes, France, 44000
3
CHU de Nice
Nice, France, 06000
4
CHU Stransbourg
Strasbourg, France, 67000