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

NCT06003257 | Completed DMC

• 1 other identifier: 286/2020
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Caries of Infancy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Measuring of gingival marginal status

  immediately after cementation, after 1 month, 3 months, 6 months, 9 months and 12 months

• Measuring of parental satisfaction

  immediately after cementation, after 1 month, 3 months, 6 months, 9 months and 12 months

Study Arms (3)

primary molars will be restored by stainless steel crowns

ACTIVE COMPARATOR

Other: stainless steel crown

primary molars will be restored by zirconia crowns

ACTIVE COMPARATOR

Other: zirconia crown

primary molars will be restored by fiberglass crowns.

ACTIVE COMPARATOR

Other: fiberglass crown

Interventions

stainless steel crown OTHER

stainless steel full coverage crown for deciduous teeth

primary molars will be restored by stainless steel crowns

zirconia crown OTHER

zirconia full coverage crown for deciduous teeth

primary molars will be restored by zirconia crowns

fiberglass crown OTHER

fiberglass full coverage crown for deciduous teeth

primary molars will be restored by fiberglass crowns.

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \. 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:
• Multi-surfaces caries more than two surfaces
• Pulp therapy treated primary molars
• Developmental defects on tooth surface
• Root resorption less than/ equal to1/3rd of root length 5. Parent willing to participate in the study.

You may not qualify if:

• Patient with primary molars have the following criteria:
• Acute infection
• Infra-occlusion
• Mobility
• Internal root resorption
• Exfoliation imminent

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

faculty of dentistry Suez canal university

Ismailia, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 8, 2023
• First Posted: August 21, 2023
• Study Start: March 23, 2022
• Primary Completion: March 28, 2023
• Study Completion: May 13, 2023
• Last Updated: August 21, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)