Comparison Between Stainless-Steel, Zirconia and Fiberglass Crowns for Deciduous Molars

Caries of Infancy Clinical Trial

Official title:

Comparison Between Stainless-Steel, Zirconia and Fiberglass Crowns as Full Coverage Restoration for Deciduous Molars of Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06003257
• Other study ID #: 286/2020
• Status: Completed
• Phase: N/A
• Start date: March 23, 2022
• Est. completion date: May 13, 2023

Study information

• Verified date: June 2023
• Source: Suez Canal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: May 13, 2023
• Est. primary completion date: March 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 8 Years

Eligibility

Inclusion Criteria:

• 1. 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:

1. Multi-surfaces caries more than two surfaces

2. Pulp therapy treated primary molars

3. Developmental defects on tooth surface

4. Root resorption less than/ equal to1/3rd of root length 5. Parent willing to participate in the study.

Exclusion Criteria:

• Patient with primary molars have the following criteria:

1. Acute infection

2. Infra-occlusion

3. Mobility

4. Internal root resorption

5. Exfoliation imminent

Related Conditions & MeSH terms

• Caries of Infancy

Intervention

Other:
• stainless steel crown
stainless steel full coverage crown for deciduous teeth
• zirconia crown
zirconia full coverage crown for deciduous teeth
• fiberglass crown
fiberglass full coverage crown for deciduous teeth

Locations

Country	Name	City	State
Egypt	faculty of dentistry Suez canal university	Ismailia

Sponsors (1)

Lead Sponsor	Collaborator
Suez Canal University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	immediately after cementation, after 1 month, 3 months, 6 months, 9 months and 12 months
Secondary	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	immediately after cementation, after 1 month, 3 months, 6 months, 9 months and 12 months
Secondary	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	immediately after cementation, after 1 month, 3 months, 6 months, 9 months and 12 months