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

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

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.

Study Overview

• Status: Completed
• Conditions: Caries of Infancy
• Intervention / Treatment: Other: stainless steel crown; Other: zirconia crown; Other: fiberglass crown

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

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Ismailia, Egypt
    • Faculty of Dentistry Suez Canal University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: primary molars will be restored by stainless steel crowns	Other: stainless steel crown; stainless steel full coverage crown for deciduous teeth
Active Comparator: primary molars will be restored by zirconia crowns	Other: zirconia crown; zirconia full coverage crown for deciduous teeth
Active Comparator: primary molars will be restored by fiberglass crowns.	Other: fiberglass crown; fiberglass full coverage crown for deciduous teeth

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Suez Canal University

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2022
• Primary Completion (Actual): March 28, 2023
• Study Completion (Actual): May 13, 2023

Study Registration Dates

• First Submitted: July 8, 2023
• First Submitted That Met QC Criteria: August 19, 2023
• First Posted (Actual): August 21, 2023

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 19, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 286/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No