| CTRI Number |
CTRI/2022/03/041134 [Registered on: 16/03/2022] 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
|
Clinical Comparison of two different types of crowns in primary teeth. |
|
Scientific Title of Study
|
Comparative evaluation of clinical success of stainless steel and Kids-e- Bioflex crowns in primary teeth – A split mouth prospective randomized clinical study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amol Patil |
| Designation |
Associate Professor |
| Affiliation |
M A Rangoonwala College of Dental Sciences and Research Institute Pune |
| Address |
M A Rangoonwala College of Dental Sciences and Research Institute, Department of Pedodontics, room no 206, Camp, Pune
Pune
MAHARASHTRA
411001
India |
| Phone |
9561042279 |
| Fax |
|
| Email |
amolpatil2526@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amol Patil |
| Designation |
Associate Professor |
| Affiliation |
M A Rangoonwala College of Dental Sciences and Research Institute Pune |
| Address |
M A Rangoonwala College of Dental Sciences and Research Institute, Department of Pedodontics, room no 206, Camp, Pune
Pune
MAHARASHTRA
411001
India |
| Phone |
9561042279 |
| Fax |
|
| Email |
amolpatil2526@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amol Patil |
| Designation |
Associate Professor |
| Affiliation |
M A Rangoonwala College of Dental Sciences and Research Institute Pune |
| Address |
M A Rangoonwala College of Dental Sciences and Research Institute, Department of Pedodontics, room no 206, Camp, Pune
Pune
MAHARASHTRA
411001
India |
| Phone |
9561042279 |
| Fax |
|
| Email |
amolpatil2526@gmail.com |
|
|
Source of Monetary or Material Support
|
| M A RANGOONWALA COLLEGE OF DENTAL SCIENCES AND RESEARCH INSTITUTE, DEPARTMENT OF PEDIATRIC DENTISTRY, ROOM NO 206, CAMP ,PUNE |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| 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 Patil |
M A Rangoonwala College of Dental Sciences and Research Institute |
M A Rangoonwala College of Dental Sciences and Research
Institute, Department of Pedodontics, room no 206, Camp, Pune
Pune
MAHARASHTRA
411001
Pune
MAHARASHTRA |
9561042279
amolpatil2526@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of M.C.E. Society, Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
dental caries |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Kids-e-Bioflex Crown |
The tooth will be anesthetized, rubber dam will be placed, crown selection will be carried out first for Kids-e-bioflex 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-Bioflex 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.
|
| Intervention |
Stainless Steel |
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
|
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Parents willing to give consent.
Primary teeth indicated for full coverage restoration.
Frankel’s positive and definitely positive patients
Children aged between 4 to 10 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 below the age of 4 and above the
age of 10.
Children with special needs.
Inadequate root length.
Presence of malocclusion like cross bite, crowding, scissor bite etc.
Child allergic to local anesthesia, chromium, or nickel
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
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
|
one 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.
|
one year |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "38"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
20/03/2022 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [amolpatil2526@gmail.com].
- For how long will this data be available start date provided 20-02-2023 and end date provided 20-05-2023?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Dental
caries is an infectious transmittable bacterial disease, which is characterized
by a multi-factorial pathology.1 In the early childhood the caries
(ECC) have effects on both dental and general health of the child.2
Oral health impacts on the quality of life of children 3, 4.
However, extreme caries have a noticeable impact on the diameter of the arch.5
In
order to preserve the functional integrity of primary dentition, it is
important to perform different restorative treatment due to an increase in the
prevalence of dental caries today.6 In all restorative procedures,
there is a loss of some amount of tooth structure, these damaged teeth can be
restored with various restorative materials such as resin modified glass
ionomer cement, resin filled composite or resin filled composite.7 For
primary molar teeth, preformed metal crown were first described by Engle8
in year 1950 and followed by Humphrey.9 Since then, crown design
modifications are done, to improve morphology of crown and to simplify the
fitting procedure.10 Stainless steel crowns are the first choice for
restoring defects due to caries in primary dentition and the most reliable and
successful form of tooth restoration is in pediatric dentistry.9
Stainless steel crown placement is easy and economical with a high success rate
for preserving remaining teeth damaged by excessive preparation.11,12
Esthetic concern is reported to be the most important problem for dental
restoration in a study in pediatric patients.13Accordingly, new
materials have been created to replace SSCs, such as bonded strip crowns,
open-faced crowns and pre-veneered SSCs.14,15 These new materials
have enhanced aesthetics but have side effects such as poor gingival health and
dental margin exposure due to metal presence.11 In particular
pre-veneered SSC veneer resin sometimes chips and results in additional care..15,16
Today,
for the restoration of the primary teeth, the dental practitioner has various
options like preformed zirconia crowns for esthetic concern. Based on
technical, functional and esthetic limitations, each technique is associated
with the own sets of advantages and disadvantages.17, 18, 19
Alternative to these, prefabricated esthetic
flexible crowns are comparatively new. Flexible crowns allow practitioner to
provide aesthetics of new age crowns and easy, economical as well as
conservative preparation of stainless steel crowns in addition to that they can be corrected like SSCs and that’s
the reason this study is planned |