NCT06003257

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

Completed NA Last updated 21 August 2023

What this trial tests

NA trial testing stainless steel crown in Caries of Infancy in 44 participants. Completed in 13 May 2023.

Timeline

23 March 2022

Primary endpoint
28 March 2023

13 May 2023

Quick facts

Lead sponsor	Suez Canal University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	triple
Primary purpose	treatment
Enrollment	44
Start date	23 March 2022
Primary completion	28 March 2023
Estimated completion	13 May 2023
Sites	1 location across Egypt

Drugs / interventions tested

• stainless steel crown
• zirconia crown
• fiberglass crown

Conditions studied

• Caries of Infancy — all drugs for Caries of Infancy →

Sponsor

Suez Canal University

Who can join

Adults 4 to 8, any sex, with Caries of Infancy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.