Primary TeethNCT06433141
Evaluation of Bioflex Crowns Endocrowns Compared to Ready-Made Zirconia Crowns on Pulpotomized Primary Molars
A study testing treatment option for primary second molar in people with Primary Teeth, run by Al-Azhar University at 1 site in Egypt.
Trial summary
This study will be conducted to evaluate clinical performance, parent's satisfaction, gingival health and bacterial effects of Bioflex crowns \&Endocrowns compared to ready-made zirconia Crowns on Pulpotomized primary molars Read more about this study
- Who is it for?
- Ages 4 to 8 years
- Conditions the study is for
- Primary Teeth
- What is being tested?
- treatment option for primary second molar
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteEgypt
- Study dates
- 19 Dec 2023to 30 Aug 2025
- 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 - Parents' and patients' acceptance and cooperation 2- Apparently Healthy children. 3- Child's age ranging from 4 to 8 years old. 4- Primary 2nd molars with deep carious lesion indicated for vital Pulptomy 5- No periapical pathological lesion 6- No root resorption exceeding more than 2/3 of root length.
Who cannot join
- Medically compromised children (bleeding disorders, cardiac patient and any systemic diseases could affect oral and gingival health.
- Presence of para-functional habits. Such bruxism, TMJ disorders
- Non-restorable tooth.
- Teeth with non-vital pulp
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Clinical Performance, Parent's Satisfaction, Gingival Health and Bacterial Effects of Bioflex Crowns & Endocrowns Compared to Ready-Made Zirconia Crowns on Pulpotomized Primary Molars: A Randomized Clinical Trial
This study will be conducted to evaluate clinical performance, parent's satisfaction, gingival health and bacterial effects of Bioflex crowns \&Endocrowns compared to ready-made zirconia Crowns on Pulpotomized primary molars
Read the detailed description
Intervention: Pulptomy Procedures The tooth will be anaesthetized. Then, it will be isolated using a rubber dam. Caries will be removed with a sterile non-end cutting bur # 558 to complete the removal of the pulp chamber roof under copious water coolant spray. Coronal pulp tissue remnants will be removed with a sharp, sterile excavator. A piece of cotton soaked with formocresol will be inserted into the pulp chamber for 5 minutes. After removing the formocresol pellet, a thick mix of zinc- oxide/eugenol paste will be packed into the pulp chamber to seal the orifices.
Restoration of the tooth:
According to the groups restoration will be as the following:
Group A: Endocrowns tooth preparation, scanning, cementation:
For the endocrowns A layer of light -cured glass ionomer cement ° of 1 mm thickness will be applied over the ZOE- to isolate it from the successive resin based restorations and adhesives- leaving a minimum of 3 mm of the pulp chamber to provide an adequate thickness for the endocrown core.
Round-end tapered stone will be used to achieve depth cuts of 1.5 mm for occlusal clearance A wheel stone will complete the occlusal reduction and making butt joint finish line.
Tapered stone of 8-degree angle will be used to prepare axial wall flared, the pulp chamber walls to a standard degree of divergence.
Abrasive rubber tip will be used to smoothening and rounding the internal angles giving a polished and smoothed preparation.
Endocrown will be manufactured using CAD/CAM technology internal wall of crown will be treated with etchant material, rinsed, dried then silane coupling agent Dual-cure resin cement will be applied on the crown fitting surface for endocrown cementation. Group B: Preformed Bioflex crowns
According to manufacturer instruction the preparation will be as the follow:
Light -cured glass ionomer filling of adequate thickness will be applied over the ZOE to seal the cavity before preparation A digital caliper will be used to measure a mesio-distal dimension of tooth then suitable sized preformed crown will be selected.
Tooth preparation will be carried out with a tapered diamond bur for occlusal reduction by 1-1.5 mm, including the central groove.
The proximal preparation will be around 0.5 mm to clear the contact area Placement of the crown will be achieved by a snug fit followed by contouring using a Hover's plier.
Crown cementation will be carried out using glass ionomer cement and removal of excess cement using floss or explorer.
Group C: performed zirconia crowns Light -cured glass ionomer filling of adequate thickness will be applied over the ZOE to seal the cavity before preparation.
A digital caliper will be used to measure a mesio-distal dimension of tooth then suitable sized preformed crown will be selected.
A diamond bur will reduce the occlusal surface by 1.5-2 mm Interproximal contacts will be prepared with a tapered fissure bur. About 1-2 mm sub gingival preparation will be performed The selected crown will be placed and checked. The passive fit of the crown will be assessed and will be luted with glass ionomer cement.
Consistent firm finger pressure will be applied during cementation. Observations:
Clinical Performance Assessment Retention, marginal adaption, fracture of the restoration were scored using a modified United States Public Health Service (USPHS) criterion.
Dental plaque accumulation and gingival condition were assessed using plaque index (PI) and GI.
Preparation time and cementation assessment using stop watch to record time from preparation start till final restoration cementation.
Clinical performance and oral status will be assessed at follow-up periods of 3 (T1), 6 (T2), and 12 (T3) months. At the end of the follow-up (T3), parent's satisfaction analysis toward the color, shape, and size of three restorations will be adopted to directly evaluate their satisfaction toward their children's restorations. Parents' responses were rated on a 5-point Likert-type scale.Microbiological analysis:
The swabs will be collected before preparation of crowns, 3 months, 6 months and 12 months after cementation. The number of Streptococcus Mutans, lactobacillus will be digitally counted. Swabs will be taken from occlusal surface by means of the tips of sterile cotton The number of Streptococcus Mutans, lactobacillus will be digitally counted. Swabs will be taken from occlusal surface by means of the tips of sterile cotton Samples will be preserved in a transporting medium tube containing 9ml thioglycolate broth medium. All specimens were transported immediately to microbiological lab.
- Conditions
- Primary Teeth
- Being tested
- treatment option for primary second molar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treatment option for primary second molarProcedure or surgery
final restoration for primary second molars
| Study group | Role | What they receive |
|---|---|---|
| bio-flex crown | Active comparator | bio-flex crown will be used as a final restoration for pulp treated primary molar, selection of suitable sized crown , it will be cement with glass ionomer cement after pulpotmy procdure clincal performance, parent satsification ,bacterial adherence will be evaluated with a follow up period 1 year Receives: Procedure: treatment option for primary second molar |
| endo-crown | Active comparator | endo-crown will be used as a final restoration for pulp treated primary molar, after pulpotomy procdure endo-crown preperation design will be done and CAD/CAM, endo crown will be luted according to e-max protocol clincal performance, parent satsification ,bacterial adherence will be evaluated with a follow up period 1 year Receives: Procedure: treatment option for primary second molar |
| zirconia crown | Other | zirconia crown will be used as a final restoration for pulp treated primary molar, selection of suitable sized crown after preperation of tooth and use try-in kit to select siutable size ,zirconia is sensitive for blood contamination , it will be cement with glass ionomer cement after pulpotmy procdure clincal performance, parent satsification ,bacterial adherence will be evaluated with a follow up period 1 year Receives: Procedure: treatment option for primary second molar |
What is being measured
The primary outcome is the main question the study is designed to answer.
retention of bio-flex crown,zirconia, and endo-crown
Retention were scored using a modified United States Public Health Service (USPHS) criterion.
Measured: follow up will be 3,6,9,12 month
marginal adaptation of bio-flex crown,zirconia, and endo-crown
marginal adaptation were scored using a modified United States Public Health Service (USPHS) criterion.
Measured: follow up will be 3,6,9,12 month
fracture of restoration of bio-flex crown,zirconia, and endo-crown
fracture of restoration were scored using a modified United States Public Health Service (USPHS) criterion.
Measured: follow up will be 3,6,9,12 month
gingival health of bio-flex crown,zirconia, and endo-crown
- Dental plaque accumulation and gingival condition were assessed using plaque index (PI) and GI.
Measured: follow up will be 3,6,9,12 month
Secondary outcomes (1)
parent's satisfaction analysis
Parents' responses were rated on a 5-point Likert-type scale.
Measured: follow up will be 3,6,9,12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study start19 Dec 2023
- Primary completion30 Mar 2024
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary TeethStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, kareem ragab abdallah el hosary, Al-Azhar University
- Investigators
- kareem elhosary, master degree, Study chair, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06433141
- Sponsor's protocol ID
- 966/5604
- Status last verified
- May 2024
- First submitted
- 12 May 2024
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical Performance, Parent's Satisfaction, Gingival Health and Bacterial Effects of Bioflex Crowns & Endocrowns Compared to Ready-Made Zirconia Crowns on Pulpotomized Primary Molars: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06433141
- Acronym / sponsor ID
- 966/5604
- Conditions
- Primary Teeth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 19 Dec 2023 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 29 May 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 clinical performance, parent's satisfaction, gingival health and bacterial effects of Bioflex crowns \&Endocrowns compared to ready-made zirconia Crowns on Pulpotomized primary molars
Detailed description
Intervention: Pulptomy Procedures The tooth will be anaesthetized. Then, it will be isolated using a rubber dam. Caries will be removed with a sterile non-end cutting bur # 558 to complete the removal of the pulp chamber roof under copious water coolant spray. Coronal pulp tissue remnants will be removed with a sharp, sterile excavator. A piece of cotton soaked with formocresol will be inserted into the pulp chamber for 5 minutes. After removing the formocresol pellet, a thick mix of zinc- oxide/eugenol paste will be packed into the pulp chamber to seal the orifices.
Restoration of the tooth:
According to the groups restoration will be as the following:
Group A: Endocrowns tooth preparation, scanning, cementation:
For the endocrowns A layer of light -cured glass ionomer cement ° of 1 mm thickness will be applied over the ZOE- to isolate it from the successive resin based restorations and adhesives- leaving a minimum of 3 mm of the pulp chamber to provide an adequate thickness for the endocrown core.
Round-end tapered stone will be used to achieve depth cuts of 1.5 mm for occlusal clearance A wheel stone will complete the occlusal reduction and making butt joint finish line.
Tapered stone of 8-degree angle will be used to prepare axial wall flared, the pulp chamber walls to a standard degree of divergence.
Abrasive rubber tip will be used to smoothening and rounding the internal angles giving a polished and smoothed preparation.
Endocrown will be manufactured using CAD/CAM technology internal wall of crown will be treated with etchant material, rinsed, dried then silane coupling agent Dual-cure resin cement will be applied on the crown fitting surface for endocrown cementation. Group B: Preformed Bioflex crowns
According to manufacturer instruction the preparation will be as the follow:
Light -cured glass ionomer filling of adequate thickness will be applied over the ZOE to seal the cavity before preparation A digital caliper will be used to measure a mesio-distal dimension of tooth then suitable sized preformed crown will be selected.
Tooth preparation will be carried out with a tapered diamond bur for occlusal reduction by 1-1.5 mm, including the central groove.
The proximal preparation will be around 0.5 mm to clear the contact area Placement of the crown will be achieved by a snug fit followed by contouring using a Hover's plier.
Crown cementation will be carried out using glass ionomer cement and removal of excess cement using floss or explorer.
Group C: performed zirconia crowns Light -cured glass ionomer filling of adequate thickness will be applied over the ZOE to seal the cavity before preparation.
A digital caliper will be used to measure a mesio-distal dimension of tooth then suitable sized preformed crown will be selected.
A diamond bur will reduce the occlusal surface by 1.5-2 mm Interproximal contacts will be prepared with a tapered fissure bur. About 1-2 mm sub gingival preparation will be performed The selected crown will be placed and checked. The passive fit of the crown will be assessed and will be luted with glass ionomer cement.
Consistent firm finger pressure will be applied during cementation. Observations:
Clinical Performance Assessment Retention, marginal adaption, fracture of the restoration were scored using a modified United States Public Health Service (USPHS) criterion.
Dental plaque accumulation and gingival condition were assessed using plaque index (PI) and GI.
Preparation time and cementation assessment using stop watch to record time from preparation start till final restoration cementation.
Clinical performance and oral status will be assessed at follow-up periods of 3 (T1), 6 (T2), and 12 (T3) months. At the end of the follow-up (T3), parent's satisfaction analysis toward the color, shape, and size of three restorations will be adopted to directly evaluate their satisfaction toward their children's restorations. Parents' responses were rated on a 5-point Likert-type scale.Microbiological analysis:
The swabs will be collected before preparation of crowns, 3 months, 6 months and 12 months after cementation. The number of Streptococcus Mutans, lactobacillus will be digitally counted. Swabs will be taken from occlusal surface by means of the tips of sterile cotton The number of Streptococcus Mutans, lactobacillus will be digitally counted. Swabs will be taken from occlusal surface by means of the tips of sterile cotton Samples will be preserved in a transporting medium tube containing 9ml thioglycolate broth medium. All specimens were transported immediately to microbiological lab.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| bio-flex crown | Active comparator | Procedure: treatment option for primary second molarbio-flex crown will be used as a final restoration for pulp treated primary molar, selection of suitable sized crown , it will be cement with glass ionomer cement after pulpotmy procdure clincal performance, parent satsification ,bacterial adherence will be evaluated with a follow up period 1 year |
| endo-crown | Active comparator | Procedure: treatment option for primary second molarendo-crown will be used as a final restoration for pulp treated primary molar, after pulpotomy procdure endo-crown preperation design will be done and CAD/CAM, endo crown will be luted according to e-max protocol clincal performance, parent satsification ,bacterial adherence will be evaluated with a follow up period 1 year |
| zirconia crown | Other | Procedure: treatment option for primary second molarzirconia crown will be used as a final restoration for pulp treated primary molar, selection of suitable sized crown after preperation of tooth and use try-in kit to select siutable size ,zirconia is sensitive for blood contamination , it will be cement with glass ionomer cement after pulpotmy procdure clincal performance, parent satsification ,bacterial adherence will be evaluated with a follow up period 1 year |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 1 - Parents' and patients' acceptance and cooperation 2- Apparently Healthy children. 3- Child's age ranging from 4 to 8 years old. 4- Primary 2nd molars with deep carious lesion indicated for vital Pulptomy 5- No periapical pathological lesion 6- No root resorption exceeding more than 2/3 of root length.
Key exclusion criteria (4 listed)
- Medically compromised children (bleeding disorders, cardiac patient and any systemic diseases could affect oral and gingival health.
- Presence of para-functional habits. Such bruxism, TMJ disorders
- Non-restorable tooth.
- Teeth with non-vital pulp
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 |
|---|---|---|
| treatment option for primary second molarfinal restoration for primary second molars | Procedure or surgery | bio-flex crown, endo-crown, zirconia crown |
Primary outcome
retention of bio-flex crown,zirconia, and endo-crown
Time frame: follow up will be 3,6,9,12 month
Retention were scored using a modified United States Public Health Service (USPHS) criterion.
marginal adaptation of bio-flex crown,zirconia, and endo-crown
Time frame: follow up will be 3,6,9,12 month
marginal adaptation were scored using a modified United States Public Health Service (USPHS) criterion.
fracture of restoration of bio-flex crown,zirconia, and endo-crown
Time frame: follow up will be 3,6,9,12 month
fracture of restoration were scored using a modified United States Public Health Service (USPHS) criterion.
gingival health of bio-flex crown,zirconia, and endo-crown
Time frame: follow up will be 3,6,9,12 month
• Dental plaque accumulation and gingival condition were assessed using plaque index (PI) and GI.
1 secondary outcome
parent's satisfaction analysis
Time frame: follow up will be 3,6,9,12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Individual participant dataSharing planned: Yes
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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.
kareem elhosary, master degree study chair
Al-Azhar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing treatment option for primary second molar in people with Primary Teeth, run by Al-Azhar 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 1 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 29 May 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?
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?
retention of bio-flex crown,zirconia, and endo-crown (time frame: follow up will be 3,6,9,12 month). The study lists 4 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 29 May 2024.