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Preformed Pediatric Crown Zirconia Versus Preformed Pediatric Metal Crown (CPP Z-M)

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ClinicalTrials.gov Identifier: NCT03296709
Recruitment Status : Not yet recruiting
First Posted : September 28, 2017
Last Update Posted : July 24, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Brief Summary:

Preformed metal pediatric crowns (CPPm) are currently considered the best method of restoring temporary molars affected by severe carious lesions compared to restorations made with various restorative materials (amalgams, composites, CVI-based materials). Due to their unsightly appearance, denounced by many parents, more aesthetic zirconia (CPPz) preformed pediatric crowns have been recently marketed. In the absence of an evaluation of the latter, this multi-center fractional oral clinical trial proposes to evaluate clinically and radiographically the success rate of pediatric preformed zirconia and metallic crowns.

One hundred children aged at least 4 years must be recruited in eight departments of odontology pediatric hospital-university (Bordeaux, Lille, Nancy, Nantes, Nice, Paris, Strasbourg, Toulouse). They will be included if they have two similar temporary molars of the same arch (eg first right maxillary temporal molars left) and equally affected, to be crowned. The two types of crowns to be used in the same child, CPPm (3M Espe) and CPPz (Ezpédo), will be affected by drawing lots. The children will be checked every 6 months for a period of 2 years after the placement of the two types of crowns at one week intervals. During these four control visits, the success associated with an absence of signs and symptoms of irreversible pulpitis or periodontal complications will be sought (main endpoint). At the same time, the rate of retention and fracture of CPPs, the gingival condition in the vicinity of the analgesics, the antagonist tooth wear and the parental satisfaction and that of the children related to each treatment (judgment criteria secondary). Each center has a trained and / or calibrated operator and evaluator.


Condition or disease Intervention/treatment Phase
Tooth Decay Device: CPP z Device: CPP m Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: split mouth design
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preformed Pediatric Crown Zirconia Versus Preformed Pediatric Metal Crown CppZ-M
Estimated Study Start Date : September 15, 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Zirconium

Arm Intervention/treatment
Active Comparator: CPP m Device: CPP m
Installation of a preformed pediatric metal crown

Experimental: CPP z Device: CPP z
Installation of a preformed pediatric zircone crown




Primary Outcome Measures :
  1. clinical and radiographique observations [ Time Frame: 2 years ]
    Success corresponding to the absence of major failure defined as a composite measure considering both the signs and symptoms associated with irreversible pulpitis or periodontal complication



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Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.
  • Temporary molar whose physiological fall must occur within the next 24 months or when root resorption has already involved more than one-third of the root length.
  • Temporarily dilapidated temporary molar prohibiting retention and waterproofing of the restoration.
  • Temporary molar associated with a vestibular arch.
  • Molar whose cementum has been exposed.
  • Molar with spontaneous pain.
  • Temporary molar in infraclusion.
  • Temporary molar, the radiographic examination of which reveals an enlargement of the periodontal space, the presence of a radioclay image in the furcation and / or periapical regions, or even an internal or external resorption.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03296709


Contacts
Contact: Michele MULLER BOLLA 33 4 92 03 32 70 michele.muller@unice.fr
Contact: mélanie bonnard bonnard.m@chu-nice.fr

Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT03296709     History of Changes
Other Study ID Numbers: 17-PP-08
First Posted: September 28, 2017    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No