Dental RestorationNCT06450093
Comparative Clinical Evaluation of BioFlx, Zirconia, and Stainless-Steel Crowns in Primary Molars
A study testing Preformed stainless steel crown., Preformed zirconia crown and Preformed BioFlx crown in people with Dental Restoration, run by Mansoura University at 1 site in Egypt.
Trial summary
This study will be conducted to: Evaluate and compare the clinical success, periodontal changes, and wear of antagonist teeth for three types of prefabricated crowns in primary molars: BioFlx crowns, Zirconia crowns, and Stainless Steel crowns. Read more about this study
- Who is it for?
- Ages 4 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Restoration
- What is being tested?
- Preformed stainless steel crown., Preformed zirconia crown and Preformed BioFlx crown
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Apr 2024to 1 Jun 2026
- 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 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children who are free from any systemic disease.
- Children with a carious lower primary molar indicated for crown restoration.
- Teeth with an intact antagonist and neighboring primary molar.
- Cooperative children with scores 1 and 2 (positive or definitely positive) according to Frankl's behavior rating scale.
Who cannot join
- Children with extremely poor oral hygiene.
- Teeth showing radiographical furcation involvement or root resorption.
- Children with para-functional habits, bruxism, or deep bite.
- Teeth with inadequate non-restorable crown structure.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, Mansoura University.
Al Mansurah, Dakahlia Governorate, 35516
Heba O Elbadry, B.D.S & M.D.S, +0201116121999, Hebaaelbadry@mans.edu.eg
About this study
Official title: Comparative Clinical Evaluation of BioFlx, Zirconia, and Stainless-Steel Crowns in Primary Molars: A Randomized Controlled Clinical Trial
This study will be conducted to:
Evaluate and compare the clinical success, periodontal changes, and wear of antagonist teeth for three types of prefabricated crowns in primary molars: BioFlx crowns, Zirconia crowns, and Stainless Steel crowns.
Read the detailed description
A randomized controlled clinical trial with three parallel groups, will be set up and reported according to the revised Consolidated Standards of Reporting Trials statement. The study will be conducted on 51 children with 51 molars aged between 4 and 7 years with a lower primary molar indicated for crown restoration. The children will be selected from the Pediatric Dental Clinic, Faculty of Dentistry, Mansoura University. They will be randomly divided into three equal groups (17 molars/each). Sequence generation and concealment will be done by a biostatistician who is not involved in the study. Group I (control group) will include stainless steel crowns, group II (study group) will include Zirconia crowns, group III (study group) will include BioFlx crowns. After obtaining the written consent form from the parents or guardians, the children will be randomly enrolled, and teeth will be assigned to the groups to receive the selected crowns. Clinical evaluation will be done concerning crown retention, color stability, secondary caries, periodontal changes, and wear of the opposing natural enamel. All crowns will be evaluated at the 3rd, 6th, 12th, and 18th months.
- Conditions
- Dental Restoration
- Being tested
- Preformed stainless steel crown., Preformed zirconia crown, Preformed BioFlx crown
- Keywords
- Bioflx Crowns, Wear, Zirconia Crowns, stainless steel Crowns, periodontal changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preformed stainless steel crown.Other
A well-fitted preformed stainless-steel crown will be chosen by measuring the mesiodistal dimension of the tooth or its contralateral counterpart, using a graduated periodontal probe for guidance. (6) Tooth preparation will be carried out with #835 diamond fissure bur to reduce occlusal surface up to 1 to 1.5 mm. The interproximal reduction will be made mesially and distally using #169 L tapered diamond bur around 0.5 mm to clear the contact area creating a feather edge finish line. The selected crown size will be checked, and a trial fit will be done before cementation. The crown will be cemented using self-cured RMGI luting cement. The excess will be removed, and proper occlusion will be checked.
Preformed zirconia crownOther
The material for crown restoration for this group is the preformed zirconia crown. Tooth preparation will be started by occlusal reduction (1 to 1.5 mm) using #835 diamond fissure bur. The interproximal reduction will be done mesially and distally with #169 L tapered diamond bur in such a way that a straight probe passes freely through the contact area. Rounding of line angles will be done and a knife-edge finish margin of the proximal surface will be obtained avoiding any ledge formation. The selected crown will be placed and checked for a passive fit. Consistent firm finger pressure will be applied during cementation with self-cured RMGI luting cement. Finally, crown placement will be checked.
Preformed BioFlx crownOther
The prefabricated BioFlx crown will be used in this group. A similar-sized preformed crown will be selected. Tooth preparation will be carried out similarly to traditional SSCs with #835 diamond fissure bur for occlusal reduction by 1-1.5 mm including the central groove. The proximal preparation will be done mesially and distally with #169 L tapered diamond bur around 0.5 mm to clear the contact area creating a feather edge finish line. Placement of the crown will be achieved by a snug fit. Crown cementation will be carried out using self-cured RMGI luting cement and the excess cement will be removed using a floss or an explorer. (13) Finally, crown placement will be checked
| Study group | Role | What they receive |
|---|---|---|
| Group I Stainless steel crowns (control group) | Other | It will include 17 molars that will be restored by a stainless steel crown. Receives: Other: Preformed stainless steel crown. |
| Group II: Preformed zirconia crown (study group) | Other | It will include 17 molars that will be restored by Zirconia crowns. Receives: Other: Preformed zirconia crown |
| Group III: Preformed BioFlx crown (study group) | Other | It will include 17 molars that will be restored by BioFlx crowns. Receives: Other: Preformed BioFlx crown |
What is being measured
The primary outcome is the main question the study is designed to answer.
Crown retention
The crown retention will be measured concerning the proper adaptation of the crown or the complete crown loss according to the following:
0 = present.
1 = absent.
Measured: After 3, 6,12,18 months
Color stability
The color stability will be evaluated using one crown from the original kit as a standard that will be held up to each crown restoration for color comparison according to the following:
0= Unchanged.
1= Minor deviation from original. 2 = Unacceptable discoloration.
Measured: After 3, 6,12,18 months
Secondary caries
Secondary caries will be measured according to USPHS by visual inspection with an explorer to inspect if there is evidence of caries with the margin of the crown restoration according to the following:
0 = no caries
1 = caries present
Measured: After 3, 6, 12,18 months
Gingival Index (Periodontal Changes)
The GI (Gingival index) will be measured by the William Gingival Probe; the values will be recorded according to the following:
0 = normal gingiva
- = mild inflammation: a slight change in color, slight edema, no bleeding on probing
- = moderate inflammation: redness, edema, glazing, or bleeding on probing
- = severe inflammation: marked redness or edema, a tendency toward spontaneous bleeding, and ulceration.
Measured: After 3, 6, 12 ,18 months
Periodontal Index (Periodontal changes)
The PI (Periodontal Index) will be measured by the William Gingival probe; the values will be recorded according to the following:
0 = no plaque
1= film at the gingival margin and adjacent tooth 2 = moderate accumulation of plaque 3 = abundance of plaque.
Measured: After 3, 6, 12 ,18 months
Periodontal pocket depth (Periodontal changes)
The PPD will be measured using a manual periodontal probe (UNC. 15 mm) according to the following:
The pocket depth will be measured in mesiobuccal, distobuccal, mesiolingual, and distolingual areas. The periodontal probe will be inserted into the gingival sulcus parallel to the longitudinal axis of the tooth and then move in a walking fashion.
Measured: After 3, 6, 12 ,18 months
Wear of the opposing natural enamel.
To evaluate the wear of the antagonistic natural enamel of the primary molar, alginate impressions will be taken immediately (baseline) and 1 year after cementation of the crowns. The resulting casts will be scanned using a 3D scanner and 3D software that will be used to calculate the maximum amount of linear wear using image superimposition techniques. The occlusal points of the crowns will be recorded in the software for measurements and comparisons, then it will be transformed into Standard Tessellation Language (STL) file format by the software
Measured: After 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start4 Apr 2024
- Primary completion4 Oct 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental RestorationStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Elbadry, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06450093
- Sponsor's protocol ID
- A0103024PP
- Status last verified
- Jun 2024
- First submitted
- 2 Jun 2024
- Last updated
- 10 Jun 2024
- Results posted
- No
- 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 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Clinical Evaluation of BioFlx, Zirconia, and Stainless-Steel Crowns in Primary Molars: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06450093
- Acronym / sponsor ID
- A0103024PP
- Conditions
- Dental Restoration
- Keywords
- Bioflx Crowns, Wear, Zirconia Crowns, stainless steel Crowns, periodontal changes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 4 Apr 2024 (actual)
- Primary completion
- 4 Oct 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 10 Jun 2024 (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.
This study will be conducted to:
Evaluate and compare the clinical success, periodontal changes, and wear of antagonist teeth for three types of prefabricated crowns in primary molars: BioFlx crowns, Zirconia crowns, and Stainless Steel crowns.
Detailed description
A randomized controlled clinical trial with three parallel groups, will be set up and reported according to the revised Consolidated Standards of Reporting Trials statement. The study will be conducted on 51 children with 51 molars aged between 4 and 7 years with a lower primary molar indicated for crown restoration. The children will be selected from the Pediatric Dental Clinic, Faculty of Dentistry, Mansoura University. They will be randomly divided into three equal groups (17 molars/each). Sequence generation and concealment will be done by a biostatistician who is not involved in the study. Group I (control group) will include stainless steel crowns, group II (study group) will include Zirconia crowns, group III (study group) will include BioFlx crowns. After obtaining the written consent form from the parents or guardians, the children will be randomly enrolled, and teeth will be assigned to the groups to receive the selected crowns. Clinical evaluation will be done concerning crown retention, color stability, secondary caries, periodontal changes, and wear of the opposing natural enamel. All crowns will be evaluated at the 3rd, 6th, 12th, and 18th months.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I Stainless steel crowns (control group) | Other | Other: Preformed stainless steel crown.It will include 17 molars that will be restored by a stainless steel crown. |
| Group II: Preformed zirconia crown (study group) | Other | Other: Preformed zirconia crownIt will include 17 molars that will be restored by Zirconia crowns. |
| Group III: Preformed BioFlx crown (study group) | Other | Other: Preformed BioFlx crownIt will include 17 molars that will be restored by BioFlx crowns. |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children who are free from any systemic disease.
- Children with a carious lower primary molar indicated for crown restoration.
- Teeth with an intact antagonist and neighboring primary molar.
- Cooperative children with scores 1 and 2 (positive or definitely positive) according to Frankl's behavior rating scale.
Key exclusion criteria (4 listed)
- Children with extremely poor oral hygiene.
- Teeth showing radiographical furcation involvement or root resorption.
- Children with para-functional habits, bruxism, or deep bite.
- Teeth with inadequate non-restorable crown structure.
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 |
|---|---|---|
| Preformed stainless steel crown.A well-fitted preformed stainless-steel crown will be chosen by measuring the mesiodistal dimension of the tooth or its contralateral counterpart, using a graduated periodontal probe for guidance. (6) Tooth preparation will be carried out with #835 diamond fissure bur to reduce occlusal surface up to 1 to 1.5 mm. The interproximal reduction will be made mesially and distally using #169 L tapered diamond bur around 0.5 mm to clear the contact area creating a feather edge finish line. The selected crown size will be checked, and a trial fit will be done before cementation. The crown will be cemented using self-cured RMGI luting cement. The excess will be removed, and proper occlusion will be checked. | Other | Group I Stainless steel crowns (control group) |
| Preformed zirconia crownThe material for crown restoration for this group is the preformed zirconia crown. Tooth preparation will be started by occlusal reduction (1 to 1.5 mm) using #835 diamond fissure bur. The interproximal reduction will be done mesially and distally with #169 L tapered diamond bur in such a way that a straight probe passes freely through the contact area. Rounding of line angles will be done and a knife-edge finish margin of the proximal surface will be obtained avoiding any ledge formation. The selected crown will be placed and checked for a passive fit. Consistent firm finger pressure will be applied during cementation with self-cured RMGI luting cement. Finally, crown placement will be checked. | Other | Group II: Preformed zirconia crown (study group) |
| Preformed BioFlx crownThe prefabricated BioFlx crown will be used in this group. A similar-sized preformed crown will be selected. Tooth preparation will be carried out similarly to traditional SSCs with #835 diamond fissure bur for occlusal reduction by 1-1.5 mm including the central groove. The proximal preparation will be done mesially and distally with #169 L tapered diamond bur around 0.5 mm to clear the contact area creating a feather edge finish line. Placement of the crown will be achieved by a snug fit. Crown cementation will be carried out using self-cured RMGI luting cement and the excess cement will be removed using a floss or an explorer. (13) Finally, crown placement will be checked | Other | Group III: Preformed BioFlx crown (study group) |
Primary outcome
Crown retention
Time frame: After 3, 6,12,18 months
The crown retention will be measured concerning the proper adaptation of the crown or the complete crown loss according to the following: 0 = present. 1 = absent.
Color stability
Time frame: After 3, 6,12,18 months
The color stability will be evaluated using one crown from the original kit as a standard that will be held up to each crown restoration for color comparison according to the following: 0= Unchanged. 1= Minor deviation from original. 2 = Unacceptable discoloration.
Secondary caries
Time frame: After 3, 6, 12,18 months
Secondary caries will be measured according to USPHS by visual inspection with an explorer to inspect if there is evidence of caries with the margin of the crown restoration according to the following: 0 = no caries 1 = caries present
Gingival Index (Periodontal Changes)
Time frame: After 3, 6, 12 ,18 months
The GI (Gingival index) will be measured by the William Gingival Probe; the values will be recorded according to the following: 0 = normal gingiva 1. = mild inflammation: a slight change in color, slight edema, no bleeding on probing 2. = moderate inflammation: redness, edema, glazing, or bleeding on probing 3. = severe inflammation: marked redness or edema, a tendency toward spontaneous bleeding, and ulceration.
Periodontal Index (Periodontal changes)
Time frame: After 3, 6, 12 ,18 months
The PI (Periodontal Index) will be measured by the William Gingival probe; the values will be recorded according to the following: 0 = no plaque 1= film at the gingival margin and adjacent tooth 2 = moderate accumulation of plaque 3 = abundance of plaque.
Periodontal pocket depth (Periodontal changes)
Time frame: After 3, 6, 12 ,18 months
The PPD will be measured using a manual periodontal probe (UNC. 15 mm) according to the following: The pocket depth will be measured in mesiobuccal, distobuccal, mesiolingual, and distolingual areas. The periodontal probe will be inserted into the gingival sulcus parallel to the longitudinal axis of the tooth and then move in a walking fashion.
Wear of the opposing natural enamel.
Time frame: After 12 months
To evaluate the wear of the antagonistic natural enamel of the primary molar, alginate impressions will be taken immediately (baseline) and 1 year after cementation of the crowns. The resulting casts will be scanned using a 3D scanner and 3D software that will be used to calculate the maximum amount of linear wear using image superimposition techniques. The occlusal points of the crowns will be recorded in the software for measurements and comparisons, then it will be transformed into Standard Tessellation Language (STL) file format by the software
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preformed stainless steel crown., Preformed zirconia crown and Preformed BioFlx crown in people with Dental Restoration, run by Mansoura 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 10 Jun 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heba 0. Elbadry (+201116121999, Hebaaelbadry@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Crown retention (time frame: After 3, 6,12,18 months). The study lists 7 primary outcomes in all. 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 10 Jun 2024.