ClinicalNCT07883187
Clinical Evaluation of Bioflx Crowns in Restoring Primary Anterior Teeth
A study testing Bioflx Crown Restoration (Group I) and Celluloid Strip Crown Restoration (Group II) in people with Clinical and Primary Teeth, run by Tanta University at 1 site in Egypt.
Trial summary
This randomized controlled clinical trial evaluates and compares the clinical success and performance of prefabricated Bioflx crowns versus conventional Celluloid strip crowns in the restoration of badly decayed or traumatized primary anterior teeth. Read more about this study
- Who is it for?
- Ages 3 to 5 years
- Conditions the study is for
- Clinical, Primary Teeth, Restoration
- What is being tested?
- Bioflx Crown Restoration (Group I) and Celluloid Strip Crown Restoration (Group II)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 9 Nov 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 3 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Healthy children aged 3-5 years with cooperative behavior (Frankl's behavior rating scale 3-4).
- Bilateral anterior primary teeth affected by multi-surface caries requiring full coronal restoration.
- At least two-thirds of the root structure is present, and adequate coronal tooth structure to retain the crown.
Who cannot join
- Non-restorable teeth
- Teeth with single-surface restorations.
- Previous full-coverage restoration or large unsuccessful restoration on the target tooth.
- Children with oral parafunctional habits (e.g., thumb sucking, bruxism).
- Advanced physiologic root resorption (>1/3).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nesma Salah Abd-Elsadek Abd-Ellatif, master contact
Egypt1 site, 1 recruiting
- Recruiting
faculty of dentistry, Tanta university
Tanta
shaimaa eldesouky, 01008994242, shaimaaeldesouky@dent.tanta.edu.eg
nahed Saied Shoker, lecturer, 01061450568, nahed.shokr@dent.tanta.edu.eg
About this study
Official title: Comparative Clinical Evaluation of Bioflx and Celluloid Strip Crowns in Restoring Primary Anterior Teeth
This randomized controlled clinical trial evaluates and compares the clinical success and performance of prefabricated Bioflx crowns versus conventional Celluloid strip crowns in the restoration of badly decayed or traumatized primary anterior teeth.
Read the detailed description
forty pediatric patients aged 3 to 5 years presenting with bilateral multi-surface carious primary anterior teeth requiring full coronal restoration are enrolled. Each child receives a Bioflx crown on one target tooth (Group I) and a Celluloid strip crown on the contralateral target tooth (Group II). Clinical outcomes are systematically evaluated at 3, 6, and 9 months post-operative using Modified United States Public Health Service (USPHS) criteria (assessing marginal integrity, color match, restoration integrity/failure rate, and proximal contacts) along with Silness-Löe Plaque and Gingival Indices.
- Conditions
- Clinical, Primary Teeth, Restoration, Crown
- Being tested
- Bioflx Crown Restoration (Group I), Celluloid Strip Crown Restoration (Group II)
- Keywords
- Bioflx, Celluloid Strip Crowns, Primary Anterior Teeth, clinical evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioflx Crown Restoration (Group I)Procedure or surgery
Preparation: Administration of 2% lidocaine local anesthesia with epinephrine; caries removal; 1-1.5 mm incisal reduction; 1 mm mesial/distal contact breaking using diamond burs; minimal labial/palatal reduction; rounding of sharp line angles.
Seating \& Cementation: Selection of appropriate Bioflx crown size via mesiodistal caliper measurement; crown try-in; cavity sealing and final cementation using self-curing glass ionomer cement (IMICRYL Nova); excess cement removal with explorer and dental floss.
Celluloid Strip Crown Restoration (Group II)Procedure or surgery
Preparation: Local anesthesia administration; caries removal; shade selection; incisal and proximal reduction.
Matrix \& Bonding: Celluloid strip crown form selected, trimmed to length, verified for cervical adaptation, and vented at the incisal edge. Enamel etched with 37% phosphoric acid (CharmEtch) for 15 seconds, rinsed, and dried. Universal bonding agent (All-Bond Universal) applied and light-cured for 15 seconds.
Placement \& Finishing: Crown form filled with shade-matched composite resin (Beautifil), seated firmly on the tooth, excess material removed, and light-cured. Celluloid form stripped off using an excavator; final polishing performed.
| Study group | Role | What they receive |
|---|---|---|
| Group I - Experimental Group (Bioflx Crowns) | Experimental | Carious primary anterior teeth prepared and restored using prefabricated translucent hybrid resin Bioflx pediatric crowns cemented with glass ionomer cement. Receives: Procedure: Bioflx Crown Restoration (Group I) |
| Group II - Control Group (Celluloid Strip Crowns) | Active comparator | Carious primary anterior teeth prepared, etched, bonded, and restored using resin composite filled inside Celluloid strip crown forms. Receives: Procedure: Celluloid Strip Crown Restoration (Group II) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Restoration Success Rate via Modified USPHS Criteria
Proportion of restored crowns categorized as clinically successful (expressed as a percentage).
Restoration success is defined as achieving Alpha (A) or Bravo (B) ratings across all four Modified USPHS parameters evaluated via visual, explorer, and dental floss inspection:
- Marginal Integrity (Alpha = smooth adaptation; Bravo = explorer catches);
- Color Match (Alpha = exact match; Bravo = acceptable mismatch);
- Restoration Integrity (Alpha = intact; Bravo = small material loss);
- Proximal Contact (Alpha = normal resistance to floss; Bravo = contact present without resistance).
A rating of Charlie (C) or Delta (D) in any single parameter constitutes restoration failure.
Measured: Evaluated at 3, 6, and 9 months post-operative.
Secondary outcomes (2)
Gingival Health Response (Gingival Index)
Measure Description: Evaluation of marginal gingival tissue health surrounding each restored crown using the Löe and Silness Gingival Index (GI) scored from 0 to 3 (0 = Normal gingiva; 1 = Mild inflammation/slight edema; 2 = Moderate inflammation/erythema/bleeding on probing; 3 = Severe inflammation/spontaneous bleeding).
Measured: Evaluated at baseline, 3, 6, and 9 months post-operative.
Plaque Index Score around Restored Teeth
Measure Description: Assessment of soft microbial plaque thickness at the gingival margin surrounding each crown using the Silness-Löe Plaque Index (PI) scored from 0 to 3 (0 = No plaque; 1 = Thin film at gingival margin; 2 = Moderate accumulation; 3 = Abundance of plaque).
Measured: Evaluated at baseline, 3, 6, and 9 months post-operative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start9 Nov 2025
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ClinicalStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Shaban Mohamed El-desouky, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07883187
- Sponsor's protocol ID
- # PED-11-25-3481
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Patil AS, Jain M, Choubey S, Patil M, Chunawala Y. Comparative evaluation of clinical success of Stainless Steel and Bioflx crowns in primary molar - A 12 month split mouth prospective randomized clinical trial. J Indian Soc Pedod Prev Dent. 2024 Jan 1;42(1):37-45. doi: 10.4103/JISPPD.JISPPD_484_23. Epub 2024 Apr 15.
PubMed 38616425Agrawal R, Khanduja R, Singhal M, Gupta S, Kaushik M. Clinical Evaluation of Stainless Steel Crown versus Zirconia Crown in Primary Molars: An In Vivo Study. Int J Clin Pediatr Dent. 2022 Jan-Feb;15(1):15-19. doi: 10.5005/jp-journals-10005-2134.
PubMed 35528499
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Clinical Evaluation of Bioflx and Celluloid Strip Crowns in Restoring Primary Anterior Teeth
- ClinicalTrials.gov ID
- NCT07883187
- Acronym / sponsor ID
- # PED-11-25-3481
- Conditions
- Clinical, Primary Teeth, Restoration, Crown
- Keywords
- Bioflx, Celluloid Strip Crowns, Primary Anterior Teeth, clinical evaluation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 9 Nov 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 20 Oct 2026 (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 randomized controlled clinical trial evaluates and compares the clinical success and performance of prefabricated Bioflx crowns versus conventional Celluloid strip crowns in the restoration of badly decayed or traumatized primary anterior teeth.
Detailed description
forty pediatric patients aged 3 to 5 years presenting with bilateral multi-surface carious primary anterior teeth requiring full coronal restoration are enrolled. Each child receives a Bioflx crown on one target tooth (Group I) and a Celluloid strip crown on the contralateral target tooth (Group II). Clinical outcomes are systematically evaluated at 3, 6, and 9 months post-operative using Modified United States Public Health Service (USPHS) criteria (assessing marginal integrity, color match, restoration integrity/failure rate, and proximal contacts) along with Silness-Löe Plaque and Gingival Indices.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I - Experimental Group (Bioflx Crowns) | Experimental | Procedure: Bioflx Crown Restoration (Group I)Carious primary anterior teeth prepared and restored using prefabricated translucent hybrid resin Bioflx pediatric crowns cemented with glass ionomer cement. |
| Group II - Control Group (Celluloid Strip Crowns) | Active comparator | Procedure: Celluloid Strip Crown Restoration (Group II)Carious primary anterior teeth prepared, etched, bonded, and restored using resin composite filled inside Celluloid strip crown forms. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy children aged 3-5 years with cooperative behavior (Frankl's behavior rating scale 3-4).
- Bilateral anterior primary teeth affected by multi-surface caries requiring full coronal restoration.
- At least two-thirds of the root structure is present, and adequate coronal tooth structure to retain the crown.
Key exclusion criteria (5 listed)
- Non-restorable teeth
- Teeth with single-surface restorations.
- Previous full-coverage restoration or large unsuccessful restoration on the target tooth.
- Children with oral parafunctional habits (e.g., thumb sucking, bruxism).
- Advanced physiologic root resorption (>1/3).
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 |
|---|---|---|
| Bioflx Crown Restoration (Group I)Preparation: Administration of 2% lidocaine local anesthesia with epinephrine; caries removal; 1-1.5 mm incisal reduction; 1 mm mesial/distal contact breaking using diamond burs; minimal labial/palatal reduction; rounding of sharp line angles. Seating \& Cementation: Selection of appropriate Bioflx crown size via mesiodistal caliper measurement; crown try-in; cavity sealing and final cementation using self-curing glass ionomer cement (IMICRYL Nova); excess cement removal with explorer and dental floss. | Procedure or surgery | Group I - Experimental Group (Bioflx Crowns) |
| Celluloid Strip Crown Restoration (Group II)Preparation: Local anesthesia administration; caries removal; shade selection; incisal and proximal reduction. Matrix \& Bonding: Celluloid strip crown form selected, trimmed to length, verified for cervical adaptation, and vented at the incisal edge. Enamel etched with 37% phosphoric acid (CharmEtch) for 15 seconds, rinsed, and dried. Universal bonding agent (All-Bond Universal) applied and light-cured for 15 seconds. Placement \& Finishing: Crown form filled with shade-matched composite resin (Beautifil), seated firmly on the tooth, excess material removed, and light-cured. Celluloid form stripped off using an excavator; final polishing performed. | Procedure or surgery | Group II - Control Group (Celluloid Strip Crowns) |
Primary outcome
Cumulative Restoration Success Rate via Modified USPHS Criteria
Time frame: Evaluated at 3, 6, and 9 months post-operative.
Proportion of restored crowns categorized as clinically successful (expressed as a percentage). Restoration success is defined as achieving Alpha (A) or Bravo (B) ratings across all four Modified USPHS parameters evaluated via visual, explorer, and dental floss inspection: 1. Marginal Integrity (Alpha = smooth adaptation; Bravo = explorer catches); 2. Color Match (Alpha = exact match; Bravo = acceptable mismatch); 3. Restoration Integrity (Alpha = intact; Bravo = small material loss); 4. Proximal Contact (Alpha = normal resistance to floss; Bravo = contact present without resistance). A rating of Charlie (C) or Delta (D) in any single parameter constitutes restoration failure.
2 secondary outcomes
Gingival Health Response (Gingival Index)
Time frame: Evaluated at baseline, 3, 6, and 9 months post-operative.
Plaque Index Score around Restored Teeth
Time frame: Evaluated at baseline, 3, 6, and 9 months post-operative.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Results publication: PubMed 38616425Patil AS, Jain M, Choubey S, Patil M, Chunawala Y. Comparative evaluation of clinical success of Stainless Steel and Bioflx crowns in primary molar - A 12 month split mouth prospective randomized clinical trial. J Indian Soc Pedod Prev Dent. 2024 Jan 1;42(1):37-45. doi: 10.4103/JISPPD.JISPPD_484_23. Epub 2024 Apr 15.
- Results publication: PubMed 35528499Agrawal R, Khanduja R, Singhal M, Gupta S, Kaushik M. Clinical Evaluation of Stainless Steel Crown versus Zirconia Crown in Primary Molars: An In Vivo Study. Int J Clin Pediatr Dent. 2022 Jan-Feb;15(1):15-19. doi: 10.5005/jp-journals-10005-2134.
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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.
Nesma Salah Abd-Elsadek Abd-Ellatif, master contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bioflx Crown Restoration (Group I) and Celluloid Strip Crown Restoration (Group II) in people with Clinical and Primary Teeth, run by Tanta 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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 22 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact shaimaa eldesouky, assistant professor (01008994242, shaimaaeldesouky@dent.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Restoration Success Rate via Modified USPHS Criteria (time frame: Evaluated at 3, 6, and 9 months post-operative.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07883187, which also lists 2 linked publications.
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 22 Oct 2026.