Dental CariesRCTNCT07465211
Comparative Evaluation of Clinical Success of BIOFLX Crowns and SSC in Primary Molars
A study testing US Public Health Service modified criteria and The parental satisfaction in people with Dental Caries and Restored Decayed Teeth and Post-operative Sensitivity, run by satish vishwanathaiah at 1 site in India.
Trial summary
Although Stainless steel crowns (SSC) are the gold standard treatment modality for multi-surface carious lesion in paediatric patients, the quest for metal free, aesthetic restoration with comparable features that of SSC still continues. Read more about this study
- Who is it for?
- Ages Up to 10 years
- Conditions the study is for
- Dental Caries, Restored Decayed Teeth and Post-operative Sensitivity
- What is being tested?
- US Public Health Service modified criteria and The parental satisfaction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteIndia
- Study dates
- 22 Jun 2025to 27 Sep 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 Up to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- • At least two primary molars (contra-lateral or opposing side) needing full coverage restoration.
- Consent of patient/legal guardian of the child
- Cooperative behaviour based on Frankel behaviour rating 3 or 4 (positive or definitely positive)
Who cannot join
- • Parent not willing to give consent.
- Child with special health care needs
- Uncooperative child based on Frankel rating1or 2 (definitely negative or negative)
- History of Ni-Cr allergy
Trial locations and contacts
1 site in 1 country.
India1 site
Mahatma Gandhi dental college and hospital
Jaipur, Rajasthan, 302022
About this study
Official title: Comparative Evaluation of Clinical Success of BIOFLX Crowns and SSC in Primary Molars - A Randomised Clinical Trial
Although Stainless steel crowns (SSC) are the gold standard treatment modality for multi-surface carious lesion in paediatric patients, the quest for metal free, aesthetic restoration with comparable features that of SSC still continues. This research compares the clinical effectiveness of Bioflx crowns (Kids-e-dental)TM to the "gold standard" Stainless Steel crowns (Rainbow crowns)TM
Read the detailed description
A split mouth trial was conducted among 36 children of age 6-8 years, in which Bioflx crowns (Kids-e-dental)TM and Stainless Steel crowns (Rainbow crowns)TM are placed in each primary molar in bilateral or contra-lateral sides. The clinical effectiveness is evaluated using US Public Health Service modified criteria at baseline and after 1,3,6 and 12 months. The parental satisfaction of restoration is recorded using a 5-point Likert scale at baseline and 12 months. Descriptive statistics and intra-group comparison were analyzed using Chi-square test, while intergroup comparison was analyzed using Mann-Whitney test.
- Being tested
- US Public Health Service modified criteria, The parental satisfaction
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
US Public Health Service modified criteriaProcedure or surgery
1, 3 , 6 and 12 months
The parental satisfactionProcedure or surgery
rated as (1) strongly disagree, (2) disagree, (3) not sure, (4) agree, and (5) strongly agree for five variables - color, size, shape, fit and overall satisfaction. The score 1 and 2 were combined as satisfied, Score 3 indicated neutral response, Score 4 and 5 were combined as dissatisfied
| Study group | Role | What they receive |
|---|---|---|
| BIOFLX crowns ( kids-e-dental) | Experimental | Crowns placed Receives: Procedure: US Public Health Service modified criteria; Procedure: The parental satisfaction |
| Stainless steel crowns (Rainbow crowns) | Active comparator | Crowns Receives: Procedure: US Public Health Service modified criteria; Procedure: The parental satisfaction |
What is being measured
The primary outcome is the main question the study is designed to answer.
US Public Health Service (USPHS) modified criteria
The following variableswere assessed; retention, color match, marginal discoloration and adaptation, secondary caries, wear and post-operative sensitivity
Measured: 1st month, 3rd month, 6th month and 12 th month
Secondary outcomes (1)
The parental satisfaction
5-point Likert scale developed by Alkhouli et al rated as (1) strongly disagree, (2) disagree, (3) not sure, (4) agree, and (5) strongly agree for five variables - color, size, shape, fit and overall satisfaction. The score 1 and 2 were combined as satisfied, Score 3 indicated neutral response, Score 4 and 5 were combined as dissatisfied
Measured: 1st month and 12th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start22 Jun 2025
- Primary completion25 Sep 2025
- Study completion27 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- satish vishwanathaiah
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, satish vishwanathaiah, University of Jazan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07465211
- Sponsor's protocol ID
- mahatma gandhi dental college
- Acronym
- RCT
- Status last verified
- Mar 2026
- First submitted
- 6 Jan 2026
- Last updated
- 11 Mar 2026
- 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 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Clinical Success of BIOFLX Crowns and SSC in Primary Molars - A Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT07465211
- Acronym / sponsor ID
- RCT / mahatma gandhi dental college
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- satish vishwanathaiahOther government
- Study start
- 22 Jun 2025 (actual)
- Primary completion
- 25 Sep 2025 (actual)
- Study completion
- 27 Sep 2025 (actual)
- First posted
- 11 Mar 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.
Although Stainless steel crowns (SSC) are the gold standard treatment modality for multi-surface carious lesion in paediatric patients, the quest for metal free, aesthetic restoration with comparable features that of SSC still continues. This research compares the clinical effectiveness of Bioflx crowns (Kids-e-dental)TM to the "gold standard" Stainless Steel crowns (Rainbow crowns)TM
Detailed description
A split mouth trial was conducted among 36 children of age 6-8 years, in which Bioflx crowns (Kids-e-dental)TM and Stainless Steel crowns (Rainbow crowns)TM are placed in each primary molar in bilateral or contra-lateral sides. The clinical effectiveness is evaluated using US Public Health Service modified criteria at baseline and after 1,3,6 and 12 months. The parental satisfaction of restoration is recorded using a 5-point Likert scale at baseline and 12 months. Descriptive statistics and intra-group comparison were analyzed using Chi-square test, while intergroup comparison was analyzed using Mann-Whitney test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BIOFLX crowns ( kids-e-dental) | Experimental | Procedure: US Public Health Service modified criteria, Procedure: The parental satisfactionCrowns placed |
| Stainless steel crowns (Rainbow crowns) | Active comparator | Procedure: US Public Health Service modified criteria, Procedure: The parental satisfactionCrowns |
Who may qualify
- Ages
- Up to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- • At least two primary molars (contra-lateral or opposing side) needing full coverage restoration.
Key exclusion criteria (4 listed)
- • Parent not willing to give consent.
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 |
|---|---|---|
| US Public Health Service modified criteria1, 3 , 6 and 12 months | Procedure or surgery | BIOFLX crowns ( kids-e-dental), Stainless steel crowns (Rainbow crowns) |
| The parental satisfactionrated as (1) strongly disagree, (2) disagree, (3) not sure, (4) agree, and (5) strongly agree for five variables - color, size, shape, fit and overall satisfaction. The score 1 and 2 were combined as satisfied, Score 3 indicated neutral response, Score 4 and 5 were combined as dissatisfied | Procedure or surgery | BIOFLX crowns ( kids-e-dental), Stainless steel crowns (Rainbow crowns) |
Primary outcome
US Public Health Service (USPHS) modified criteria
Time frame: 1st month, 3rd month, 6th month and 12 th month
The following variableswere assessed; retention, color match, marginal discoloration and adaptation, secondary caries, wear and post-operative sensitivity
1 secondary outcome
The parental satisfaction
Time frame: 1st month and 12th month
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 11 Mar 2026.
- 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.
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 US Public Health Service modified criteria and The parental satisfaction in people with Dental Caries and Restored Decayed Teeth and Post-operative Sensitivity, run by satish vishwanathaiah at 1 site in India.
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 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: finished, as of the sponsor's last update on 11 Mar 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 India. 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?
US Public Health Service (USPHS) modified criteria (time frame: 1st month, 3rd month, 6th month and 12 th month). 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 11 Mar 2026.