| CTRI Number |
CTRI/2025/01/079196 [Registered on: 22/01/2025] Trial Registered Prospectively |
| Last Modified On: |
21/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical Comparison of Anterior Aesthetic Flexible Crowns and Strip Crowns in Primary Teeth: A 12-Month RCT |
|
Scientific Title of Study
|
Comparative clinical evaluation of flexible crowns and strip crowns in primary anterior teeth: a 12-month randomized trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aditi Hagwane |
| Designation |
Post graduate student |
| Affiliation |
Pacific Dental College And Hospital, Debari, Udaipur 313024 Rajasthan India |
| Address |
Pacific Dental College And Hospital, room no 9 department of pediatric and preventive dentistry, Debari, Udaipur 313024 Rajasthan India
Udaipur RAJASTHAN 313024 India |
| Phone |
7447473539 |
| Fax |
|
| Email |
aditihagwane98@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dinesh Rao |
| Designation |
HOD PG guide |
| Affiliation |
Pacific Dental College And Hospital, Debari, Udaipur 313024 Rajasthan India |
| Address |
Pacific Dental College And Hospital, room no 9 department of pediatric and preventive dentistry, Debari, Udaipur 313024 Rajasthan India
Udaipur RAJASTHAN 313024 India |
| Phone |
9414158235 |
| Fax |
|
| Email |
pedodinesh2003@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dinesh Rao |
| Designation |
HOD PG guide |
| Affiliation |
Pacific Dental College And Hospital, Debari, Udaipur 313024 Rajasthan India |
| Address |
Pacific Dental College And Hospital, room no 9 department of pediatric and preventive dentistry, Debari, Udaipur 313024 Rajasthan India
Udaipur RAJASTHAN 313024 India |
| Phone |
9414158235 |
| Fax |
|
| Email |
pedodinesh2003@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pacific Dental College And Hospital Debari Udaipur 313024 |
|
|
Primary Sponsor
|
| Name |
Aditi Hagwane |
| Address |
Pacific Dental College And Hospital, Debari, Udaipur 313024 Rajasthan India |
| 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 Aditi Hagwane |
Pacific Dental College And Hospital Debari Udaipur 313024 |
Department of pediatric and preventive dentistry first floor room number nine Pacific Dental College And Hospital Debari Udaipur 313024 Udaipur RAJASTHAN |
7447473539
aditihagwane98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional research review board (Pacific dental college and hospital debari udaipur 313024 rajasthan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
anterior flexible crown bioflx crowns |
new prefabricated aesthetic flexible crowns, made up of Bis -GMA free and metal free high strength resin polymer has been introduced as
Bioflx crowns
12 months follow up study |
| Comparator Agent |
Resin composite strip crowns
|
Widely used crown
Prefabricated
Transparent
Reasonable success
Aesthetic full coverage
12 months follow up study
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
Healthy three to six years old children
Primary anterior teeth indicated for full coverage restoration
Those having opposed anterior teeth
Minimal of two surfaces of caries in the targeted teeth
Patient with Early Childhood Caries as defined by AAPD, 2016
Cooperative patients who had behaviour rating positive or definitely positive followed the Frankl behaviour classification scale
|
|
| ExclusionCriteria |
| Details |
Teeth with proximity to exfoliation and resorption of the root passed its half
Presence of single surface caries not involving the proximal surfaces
Teeth that have been subjected to trauma
Anxiety and lack of cooperation which required treatment under general anaesthesia
Bruxism
Special health needs
Presences of teeth wear on the opposing teeth, or absence of opposing
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Bioflx crown is superior aesthetically and in retention than the anterior strip crowns.
|
Outcome will be analyzed at 1 week, 1month, 3months, 6 months, and 12 months.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
There might be chances of staining in strip crown and would be more technique sensitive than bioflx crown.
|
Evaluation will be done at interval of 1 week, 1, 3, 6&12 months |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/02/2025 |
| 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) |
Not Yet Recruiting |
|
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
|
| Early childhood caries (ECC) is a chronic multifactorial disorder which continues to be dominant in children, especially in families of low socioeconomic status. Early childhood caries is defined as the existence of one or more tooth decays (non-cavitated or cavitated lesions), missing (due to caries), or filled tooth surfaces in any primary dentition of children under the age of six years. Severe early childhood caries (S-ECC) is a progressive carious form in children, categorized in accordance to the number of affected teeth and the age of patient. Providing care to children who are considered to be at risk from ECC, can be achieved by a specialist who received adequate training and has experience in treating children as well as disease process. Primary incisors with large or multi-surface caries can be restored with resin composite strip crowns if there is sufficient tooth structure after removing all carious tissues. When remaining tooth structure is minimal and not enough for bonding, pre-veneered aesthetic crowns is a favorable solution. Stainless steel crowns with cosmetic facing have good aesthetics and good retention even with minimal remaining tooth structure. Moisture and hemorrhage control are not critical with these restorations which need minimal chair time and offer full coverage and protection. The findings indicate that stainless steel crowns (SSCs) are valued for durability and cost-effectiveness, but they may cause hypersensitivity. Resin composite strip crowns are used for the rehabilitation of the primary anterior teeth using the celluloid forms of the crowns and resin composite. For many years, Strip crowns had been considered as the most aesthetic option for the mutilated primary anterior teeth. But strip crowns are highly technique sensitive, which require proper moisture control during bonding and the placement of the crowns. This isolation is difficult to obtain in children oral cavity not only due to fewer technique and materials are available for isolation in children but also because children who require these belong to the younger age group and most difficult to manage in operatory. As an alternative to all these crowns, a new prefabricated aesthetic flexible crowns, made up of hybrid polymer resin and which is Bis -GMA free and metal free high strength resin polymer has been introduced as Bioflx crowns. According to the manufacturers, they can withstand high compressive forces, and are highly durable. These flexible crowns allow the paediatric dental practitioner to provide aesthetics of new age crowns with easy manipulation, conservative preparation similar to stainless steel crowns. However, no clinical studies have yet been published looking at the clinical performance of these Bioflx crowns in the anterior region. Thus, the main purpose of this prospective, randomized clinical study is to compare the clinical efficacy of aesthetic flexible composite crown (Bioflx crowns) with a commercially available anterior composite strip crowns. The null hypothesis is that there is no difference in the clinical performance of the two-crown types. Therefore, this study will be conducted to compare and evaluate a clinical success of anterior aesthetic flexible crowns with anterior strip crowns in primary anterior teeth among children aged 3-6 years. | |