| CTRI Number |
CTRI/2025/07/091042 [Registered on: 16/07/2025] Trial Registered Prospectively |
| Last Modified On: |
15/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Comparison of two different preformed crowns in young permanent teeth |
|
Scientific Title of Study
|
Comparative evaluation of clinical success of stainless steel and Kids e Bioflx crowns in permanent
teeth – A prospective randomized clinical study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amol Suresh Patil |
| Designation |
Associate Professor |
| Affiliation |
M.A. Rangoonwala College of Dental Sciences and Research Centre, Pune, Maharashtra, India. |
| Address |
M.A. Rangoonwala College of Dental Sciences and Research Centre, Pune, Maharashtra, India.
Pune MAHARASHTRA 411001 India |
| Phone |
09561042279 |
| Fax |
|
| Email |
amolpatil2526@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Amol Suresh Patil |
| Designation |
Associate Professor |
| Affiliation |
M.A. Rangoonwala College of Dental Sciences and Research Centre, Pune, Maharashtra, India. |
| Address |
M.A. Rangoonwala College of Dental Sciences and Research Centre, Pune, Maharashtra, India.
Pune MAHARASHTRA 411001 India |
| Phone |
09561042279 |
| Fax |
|
| Email |
amolpatil2526@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Amol Suresh Patil |
| Designation |
Associate Professor |
| Affiliation |
M.A. Rangoonwala College of Dental Sciences and Research Centre, Pune, Maharashtra, India. |
| Address |
M.A. Rangoonwala College of Dental Sciences and Research Centre, Pune, Maharashtra, India.
Pune MAHARASHTRA 411001 India |
| Phone |
09561042279 |
| Fax |
|
| Email |
amolpatil2526@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Department of Pedodontics |
| Address |
Department of Pedodontics, M A Rangoonwala College of Dental Sciences and Research Institute, Azam Campus, Camp, Pune, Maharashtra, India - 411001 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Amol Suresh Patil |
M.A. Rangoonwala Dental College and Hospital |
Department of Pedodontics, M.A. Rangoonwala College of Dental Sciences and Research Centre, Pune, Maharashtra, India. Pune MAHARASHTRA |
09561042279
amolpatil2526@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee MCE Society, Azam Campus, Pune -01 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K025||Dental caries on pit and fissure surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bioflx Crown |
The tooth will be anesthetized, crown selection will be carried out first
for Kids-e-bioflx crowns. Then the PM will be prepared following the
manufacturer’s guidelines by occlusal, peripheral, and subgingival
reduction. The occlusion will be assessed for occlusal clearance.
Prepared tooth should be free from blood, saliva, residues prior to
crown cementation and Type -1 glass ionomer luting cement will be
employed for luting of Kids-e-Bioflx crowns.
After cementation, the crown surface will be cleaned and
flossing will be done in the interdental area to remove excess
cement.
Post-operative radiographs will be recorded.
The samples will be assessed as follows by the same operator.
Crown assessment:
A Clinical (criteria)
B Radiographic
Patient and parent satisfaction according to USPHS criteria
will be recorded
Occlusion ( using a articulating paper)
The crown integrity will be assessed and signs of fracture of
the crown will be checked for.
Opposing tooth and crown wear will be checked using
photographs of each recall.
The patient will be recalled after 1, 3, 6, and 12 months for assessment of all
the parameters. |
| Intervention |
Stainless Steel Crown |
The stainless steel crown selection will be carried out. Then the tooth
will be prepared by occlusal and proximal reduction as per the
guideline given by Mathewson; an SCC will be tried and adjusted to fit
the tooth. According to the manufacturing instructions, tooth
preparation will be done and occlusion will be assessed. Prepared tooth
should be free from blood, saliva, residues prior to crown cementation
and Type -1 glass ionomer luting cement will be employed for luting
of Stainless steel crowns.
After cementation, the crown surface will be cleaned and
flossing will be done in the interdental area to remove excess
cement.
Post-operative radiographs will be recorded.
The samples will be assessed as follows by the same operator.
Crown assessment
Patient and parent satisfaction according to USPHS criteria
will be recorded
Occlusion ( using a articulating paper)
The crown integrity will be assessed and signs of fracture of
the crown will be checked for.
Opposing tooth and crown wear will be checked using
photographs of each recall. (Canon 1500 D DSLR, AUTO
MODE) |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
13.00 Year(s) |
| Gender |
Both |
| Details |
Parents willing to give consent.
Permanent teeth indicated for full
coverage restoration.
Each permanent molar must have antagonist tooth present
Frankel’s positive and definitely positive
patients
Children aged between 7 to 13 years.
No significant medical history.
Patients willing to return for
follow-up examinations and evaluation.
Medically free patients
or with controlled systemic disease ASA I or II. No active periodontal diseases. |
|
| ExclusionCriteria |
| Details |
Any subject that does not fall under the inclusion criteria were
excluded.
Parents not willing to give consent.
Children with special needs.
Severely decayed permanent molar prohibiting the retention and the sealing of the restoration.
permanent molar in infraocclusion.
Presence of malocclusion like cross bite, crowding, scissor bite etc.
Child allergic to local anesthesia, chromium, or nickel |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary outcome is the success of the
treatment. Success will be defined by the
absence of major failure fracture, wear, color
change
Duration, occlusion, gingival margin extension
and parent
acceptance will be clinically evaluated at
baseline and at last appointment |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The secondary outcomes are parental and child
satisfaction (size, form, and function), retention
and fracture of the crown.
The wear of the antagonist tooth will be
recorded.
gingival condition, the wear of the antagonist
teeth, as well as both parental and child
satisfaction. |
1 year |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Dental caries is a biofilm-mediated, sugar-driven, multifactorial, dynamic
disease that results in the phasic demineralization and remineralization of
dental hard tissues. Even now the treatment of decayed primary teeth presents
significant challenges in Pediatric dentistry. The prevalence of dental caries
in children worldwide in primary teeth is 46.2% and permanent teeth is 53.8%. [1] Among
school-going children in India, the prevalence of dental caries in primary
teeth is 64 to 78%, and in permanent teeth, it is 18 to 67%. [2] An
appropriate treatment strategy is essential to overcome such a high prevalence
of disease in pediatric patients. A variety of restorative materials have been
explored to date. Full-coverage restorations have demonstrated the highest
success rates when compared to other treatment modalities. A retrospective
study by Erica Wu et.al, (2021) showed a long-term survival rate of 2 years for
primary teeth with multi-surface caries. The survival rate of teeth treated
with SSC was 92.8% and with intra-coronal restoration was 80%. [3] A
literature search by Chisin LA et.al (2018) found a success rate of 96.1%
associated with Stainless Steel Crown (SSC) in primary teeth. The main reason
for the failure of treatment with intra-coronal restoration was secondary
caries (36.5%). [4]
Full
coverage restorations have proven effective in managing primary teeth with
extensive caries. [2] Previous studies have shown that crowns
significantly reduce the risk of long-term failure and pain in deciduous molars.
[5] Thus SSC were proposed as the sole restorative option for caries
involving more than two surfaces in primary molars. The SSC are durable, relatively inexpensive and
minimally invasive; with a success rate of around 96%. [6] However,
the Nickel chromium allergies associated with SSCs, and its constitution of
heavy metals increases the risk of corrosion and are known to be cytotoxic,
Also the esthetics is compromised which makes it unacceptable in anterior
region [7]. With an increase in demand for aesthetic restorations, various
tooth-coloured crowns have been introduced. Polycarbonate crowns, Strip crowns,
Pedo jacket crowns, New millennium crowns, Pedo pearl crowns, Artglass crowns,
Preformed Zirconia Crowns (PZC), Figaro Crowns and the recently launched BioFlx
crowns (BFC).
PZC
possesses numerous advantages over the conventional SSC. It is notably strong
and provides excellent aesthetic qualities and biocompatibility. Additionally,
PZC exhibits high resistance to wear and corrosion. [8] SM Alaki et
al. reported that PZC accumulates less plaque, as observed during follow-up
visits. [9] Whereas, according to Agarwal et al. SSC were better in
terms of retention, gingival response, and tooth wear in opposing teeth when
compared to PZC during clinical evaluation of these crowns in paediatric
patients. [10] BFC introduced
in 2021 by Kids-e-Dental LLP, are monochromatic, metal-free crowns that
resemble tooth-coloured crowns. They are made from a high-strength resin
polymer commonly used in the medical device industry, offering strength,
flexibility, and durability. These crowns are autoclavable and the manufacturer
claims them to be comparable to stainless steel crowns in tooth preparation.
Recently published and only randomized clinical trial with 12 months follow-up
comparing BFC and SSC showed that the clinical performance of BFC was similar
to SSC for the restoration of primary molars, with an edge over SSC in
providing better esthetics. [11]
Akin to their clinical properties,
physical and mechanical properties are an important aspect to be studied. Clinical
studies to test these properties are time-consuming and difficult to perform.
Thus, in-vitro studies have been proven to be valuable while carrying out such
tests.
The current study aimed to determine
the physical properties of BFC and compare them with SSC and PZC; as previous
studies have assessed the physical properties of SSC and PZC, but not those of
the recently launched BFC. The null hypothesis of this study was, there is no
difference in the compressive strength, microhardness, wear, and
antimicrobial resistance of BFC, PZC, and SSC. |