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

Sponsor
Suez Canal University (Other)
Overall Status
Completed
CT.gov ID
NCT06003257
Collaborator
(none)
44
1
3
13.7
3.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: stainless steel crown
  • Other: zirconia crown
  • Other: fiberglass crown
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
44 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
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.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.
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Comparison Between Stainless-Steel, Zirconia and Fiberglass Crowns as Full Coverage Restoration for Deciduous Molars of Children
Actual Study Start Date :
Mar 23, 2022
Actual Primary Completion Date :
Mar 28, 2023
Actual Study Completion Date :
May 13, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. clinical performance " marginal integrity, color change, secondary caries and crown fractures" [immediately after cementation, after 1 month, 3 months, 6 months, 9 months and 12 months]

    Modified United States Public Health Service (USPHS) criteria will be used in terms of marginal integrity, secondary caries, color match, and crown fracture

Secondary Outcome Measures

  1. Measuring of gingival marginal status [immediately after cementation, after 1 month, 3 months, 6 months, 9 months and 12 months]

    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

  2. Measuring of parental satisfaction [immediately after cementation, after 1 month, 3 months, 6 months, 9 months and 12 months]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
4 Years to 8 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 faculty of dentistry Suez canal university Ismailia Egypt

Sponsors and Collaborators

  • Suez Canal University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Suez Canal University
ClinicalTrials.gov Identifier:
NCT06003257
Other Study ID Numbers:
  • 286/2020
First Posted:
Aug 21, 2023
Last Update Posted:
Aug 21, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 21, 2023