Caries of InfancyNCT06003257
Comparison Between Stainless-Steel, Zirconia and Fiberglass Crowns for Deciduous Molars
A study testing stainless steel crown, zirconia crown and fiberglass crown in people with Caries of Infancy, run by Suez Canal University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 to 8 years
- Conditions the study is for
- Caries of Infancy
- What is being tested?
- stainless steel crown, zirconia crown and fiberglass crown
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Mar 2022to 13 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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:
- 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.
Who cannot join
- Patient with primary molars have the following criteria:
- Acute infection
- Infra-occlusion
- Mobility
- Internal root resorption
- Exfoliation imminent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- stainless steel crown, zirconia crown, fiberglass crown
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stainless steel crownOther
stainless steel full coverage crown for deciduous teeth
zirconia crownOther
zirconia full coverage crown for deciduous teeth
fiberglass crownOther
fiberglass full coverage crown for deciduous teeth
| Study group | Role | What they receive |
|---|---|---|
| primary molars will be restored by stainless steel crowns | Active comparator | Not described Receives: Other: stainless steel crown |
| primary molars will be restored by zirconia crowns | Active comparator | Not described Receives: Other: zirconia crown |
| primary molars will be restored by fiberglass crowns. | Active comparator | Not described Receives: Other: fiberglass crown |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: immediately after cementation, after 1 month, 3 months, 6 months, 9 months and 12 months
Secondary outcomes (2)
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
Measured: 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
Measured: immediately after cementation, after 1 month, 3 months, 6 months, 9 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start23 Mar 2022
- Primary completion28 Mar 2023
- Study completion13 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caries of InfancyStudies of the same condition, open and under way.
- More trials run by Suez Canal UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06003257
- Sponsor's protocol ID
- 286/2020
- Status last verified
- Jun 2023
- First submitted
- 8 Jul 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Stainless-Steel, Zirconia and Fiberglass Crowns as Full Coverage Restoration for Deciduous Molars of Children
- ClinicalTrials.gov ID
- NCT06003257
- Acronym / sponsor ID
- 286/2020
- Conditions
- Caries of Infancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 23 Mar 2022 (actual)
- Primary completion
- 28 Mar 2023 (actual)
- Study completion
- 13 May 2023 (actual)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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:
Key exclusion criteria (6 listed)
- Patient with primary molars have the following criteria:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stainless steel crownstainless steel full coverage crown for deciduous teeth | Other | primary molars will be restored by stainless steel crowns |
| zirconia crownzirconia full coverage crown for deciduous teeth | Other | primary molars will be restored by zirconia crowns |
| fiberglass crownfiberglass full coverage crown for deciduous teeth | Other | primary molars will be restored by fiberglass crowns. |
Primary outcome
clinical performance " marginal integrity, color change, secondary caries and crown fractures"
Time frame: 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
2 secondary outcomes
Measuring of gingival marginal status
Time frame: immediately after cementation, after 1 month, 3 months, 6 months, 9 months and 12 months
Measuring of parental satisfaction
Time frame: immediately after cementation, after 1 month, 3 months, 6 months, 9 months and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for Caries of Infancy
Not yet recruiting
The Effectiveness of Motivational Interviewing in Preventing Early Childhood Caries Among Mothers of Infants in Terengganu.
Healthy Women, Caries of Infancy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stainless steel crown, zirconia crown and fiberglass crown in people with Caries of Infancy, run by Suez Canal University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical performance " marginal integrity, color change, secondary caries and crown fractures" (time frame: immediately after cementation, after 1 month, 3 months, 6 months, 9 months and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2023.