Comparison Between Stainless-Steel, Zirconia and Fiberglass Crowns for Deciduous Molars
Condition: Caries of Infancy
Study type: Interventional

Summary: 
      The study will be divided into two parts: In vivo part and in vitro part.In vivo part: It
      will be a randomized clinical trial using split mouth technique on 44 primary molars in
      children aged from 4-8 years old selected from outpatient clinic of Department of Pediatric
      Dentistry, Faculty of Dentistry, Suez Canal University. The selected primary molars will be
      divided randomly into two main groups ,each group will be subdivided into two subgroups
      according to types of crowns that will be used as follows:- Group I:- comprise of 22 primary
      molars that will be subdivided into two subgroups, subgroup IA:-includes 11 primary molars
      will be restored by stainless steel crowns and subgroup IB:-includes 11 primary molars will
      be restored by zirconia crowns, Group II:- comprise of 22 primary molars that will be
      subdivided into two subgroups, subgroup IIA:-includes 11 primary molars will be restored by
      stainless steel crowns and subgroup IIB:-includes 11 primary molars will be restored by
      fiberglass crowns. The three types of crowns will be evaluated at the baseline once after
      cementation of the crowns and after one week,1 ,3,6,9 and 12 months follow up by using the
      following methods modified United States Public Health Service criteria, in terms of color
      match, marginal integrity, secondary caries and crown fracture, the gingival marginal status
      and parental satisfaction. In vitro part: It will be carried out on 30 mandibular primary
      molars, 15 mandibular first primary molars for microleakage test and 15 mandibular second
      primary molars for crown fracture resistance test for three crowns types.
    

Detailed description: 
      The study will be a randomized clinical trial using split mouth technique on 44 primary
      molars in children aged from 4-8 years old selected from outpatient Clinic of Department of
      Pediatric Dentistry, Faculty of Dentistry, Suez Canal University after approval of Research
      Ethics Committee (REC) of the Faculty of Dentistry, Suez Canal University. The children
      participants and legal guardian of each participant will be assigned on informed consent of
      treatment procedures they will receive.

      A total of 44 primary molars will be included in this study using split mouth technique to
      ensure equalizing variables for both groups.

      The selected primary molars will be divided randomly into two main groups, each group will be
      subdivided into two subgroups according to types of crowns that will be used as follows: -

        -  Group I: comprise of 22 primary molars that will be subdivided into two subgroups:

             -  Subgroup IA: includes 11 primary molars will be restored by stainless steel crowns.

             -  Subgroup IB: includes 11 primary molars will be restored by zirconia crowns.

        -  Group II: comprise of 22 primary molars that will be subdivided into two subgroups:

             -  Subgroup IIA: includes 11 primary molars will be restored by stainless steel
                crowns.

             -  Subgroup IIB: includes 11 primary molars will be restored by fiberglass crowns.

      II.4 Clinical Procedures:

        -  Eligibility criteria will be verified after the clinical and periapical radiographic
           examination.

        -  The selected primary molars will be anesthetized to reduce discomfort during
           preparation.

        -  Tooth preparation and crown cementation will be performed for each tooth according to
           the manufacture's instruction for each type of crowns.

      II.5 Methods of evaluation:

      The evaluation of each crown will be assessed at the baseline once after cementation and
      after one week,1, 3, 6,9 and 12 months follow up by using the following methods:

      II.5.1 Modified United States Public Health Service (USPHS) criteria:

      Modified United States Public Health Service (USPHS) criteria will be used in terms of
      marginal integrity, secondary caries, color match, and crown fracture
    

Intervention name(s): stainless steel crown; zirconia crown; fiberglass crown
Intervention type(s): Other; Other; Other
Intervention description(s): stainless steel full coverage crown for deciduous teeth; zirconia full coverage crown for deciduous teeth; fiberglass full coverage crown for deciduous teeth
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Group I: comprise of 22 primary molars that will be subdivided into two subgroups:
Subgroup IA: includes 11 primary molars will be restored by stainless steel crowns.
Subgroup IB: includes 11 primary molars will be restored by zirconia crowns.
Group II: comprise of 22 primary molars that will be subdivided into two subgroups:
Subgroup IIA: includes 11 primary molars will be restored by stainless steel crowns.
Subgroup IIB: includes 11 primary molars will be restored by fiberglass crowns.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment