An interventional study of stainless steel crown and zirconia crown in Caries of Infancy, sponsored by Suez Canal University. Completed at 1 site in Egypt. Open to participants aged 4 Years to 8 Years. Per ClinicalTrials.gov, last updated 2023-08-21.
Sponsored by Suez Canal University · Not applicable, Interventional, and Treatment
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.
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:
Group II: comprise of 22 primary molars that will be subdivided into two subgroups:
II.4 Clinical Procedures:
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
Suez Canal University is the lead sponsor of 157 studies on the registry; 37 are open to participants now.
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Apparently healthy children free from any systemic diseases. 2. Patient within the age group of 4 to 8 years old of both sexes. 3. Cooperative patient. 4. Patient with at least two bilateral primary molars indicated for full coverage as follows:
Exclusion Criteria:
Patient with primary molars have the following criteria:
Other: stainless steel crown
Other: zirconia crown
Other: fiberglass crown
stainless steel full coverage crown for deciduous teeth
zirconia full coverage crown for deciduous teeth
fiberglass full coverage crown for deciduous teeth
clinical performance " marginal integrity, color change, secondary caries and crown fractures"
Modified United States Public Health Service (USPHS) criteria will be used in terms of marginal integrity, secondary caries, color match, and crown fracture
Time frame: immediately after cementation, after 1 month, 3 months, 6 months, 9 months and 12 months
Measuring of gingival marginal status
The gingival marginal status will be assessed by the plaque index (PI) and gingival index where 0 normal gingiva and no plaque while 3 severe inflammation and abudance of soft matter within gingival pocket
Time frame: immediately after cementation, after 1 month, 3 months, 6 months, 9 months and 12 months
Measuring of parental satisfaction
Parental satisfaction will be evaluated on a five-point Likert scale, which responders specify their level of satisfaction. parents will ask to rate parameters such as the crown's shape, size, color, and their overall satisfaction by using Parental satisfactions questionnaire
Time frame: immediately after cementation, after 1 month, 3 months, 6 months, 9 months and 12 months
Plan to share: No
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This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Suez Canal University