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

NCT ID: NCT06003257

Last Updated: 2023-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-23
• Study Completion Date: 2023-05-13

Brief 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

Conditions

Caries of Infancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

primary molars will be restored by stainless steel crowns

Group Type: ACTIVE_COMPARATOR

stainless steel crown

Intervention Type: OTHER

stainless steel full coverage crown for deciduous teeth

primary molars will be restored by zirconia crowns

Group Type: ACTIVE_COMPARATOR

zirconia crown

Intervention Type: OTHER

zirconia full coverage crown for deciduous teeth

primary molars will be restored by fiberglass crowns.

Group Type: ACTIVE_COMPARATOR

fiberglass crown

Intervention Type: OTHER

fiberglass full coverage crown for deciduous teeth

Interventions

stainless steel crown

stainless steel full coverage crown for deciduous teeth

Intervention Type: OTHER

zirconia crown

zirconia full coverage crown for deciduous teeth

Intervention Type: OTHER

fiberglass crown

fiberglass full coverage crown for deciduous teeth

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suez Canal University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

faculty of dentistry Suez canal university

Ismailia, , Egypt

Countries

Egypt

Other Identifiers

286/2020

Identifier Type: -

Identifier Source: org_study_id