| CTRI Number |
CTRI/2022/12/048617 [Registered on: 30/12/2022] Trial Registered Prospectively |
| Last Modified On: |
09/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
clinical evaluation of 2 different types of crowns when placed with different techniques of crown placement |
|
Scientific Title of Study
|
Comparative evaluation of clinical and radiographic success after placement of preformed stainless steel and flexible esthetic crowns by various techniques in pediatric patients – A parallel group 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 M A Rangoonwala College of Dental Sciences and Research
Institute, Department of Pedodontics, room no 206, Camp, Pune
Pune
MAHARASHTRA
411001
India Pune MAHARASHTRA 411001 India |
| Phone |
|
| 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 M A Rangoonwala College of Dental Sciences and Research
Institute, Department of Pedodontics, room no 206, Camp, Pune
Pune
MAHARASHTRA
411001
India Pune MAHARASHTRA 411001 India |
| Phone |
|
| 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 M A Rangoonwala College of Dental Sciences and Research
Institute, Department of Pedodontics, room no 206, Camp, Pune
Pune
MAHARASHTRA
411001
India Pune MAHARASHTRA 411001 India |
| Phone |
|
| Fax |
|
| Email |
amolpatil2526@gmail.com |
|
|
Source of Monetary or Material Support
|
| M A Rangoonwala College of Dental Sciences
Department of Pedodontics
Room no 406
Azam Campus
Pune - 411001
|
|
|
Primary Sponsor
|
| Name |
Dr Amol Patil |
| Address |
M A Rangoonwala College of Dental Sciences and Research
Institute, Department of Pedodontics, room no 206, Camp, Pune
Pune
MAHARASHTRA
411001
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 Amol Patil |
M A Rangoonwala College of Dental Sciences and Research Institute |
Department of Pedodontics
Room no 406
Azam Campus Hidaytulla road
CAMP Pune 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 |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Conventional technique of tooth preparation |
Bioflex and stainless steel Crowns will be placed with conventional techniques of tooth preparation
duration is 12 months |
| Comparator Agent |
Different techniques of tooth preparation like halls and modified halls |
Bioflex and stainless steel crowns will be placed by different techniques of tooth preparation
duration is 12 months |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Patients and parents of the patients who accept to participate and sign the informed 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.
No active periodontal diseases.
|
|
| ExclusionCriteria |
| Details |
Patients and parents of the patients who do not accept to participate and sign the informed consent
Patients with a systemic disease,
Teeth which have a short period of time for succedaneous teeth to erupt
Any subject that does not fall under the inclusion criteria were excluded
Children with special needs.
Presence of malocclusion like cross bite, crowding, scissor bite etc.
Lived in remote villages and were unlikely to return for follow-up
Patients with TMJ abnormalities.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
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
|
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The secondary outcomes are parental and child satisfaction (size, form, and function), retention and fracture of the crown.
. Finally, the wear of the antagonist tooth will be recorded (0: absence of wear; 1: wear on only the cusp point; and 2: wear at least at the cusps) reference. To prevent information bias, the evaluators will not be the operators who applied the treatment.
|
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)
|
02/01/2023 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
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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 who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- 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 14-12-2022 and end date provided 14-12-2023?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
Brief Summary
Modification(s)
|
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 In recent years restoring carious or fractured primary teeth with stainless steel crowns (SSC) has became more popular than ever. On the other hand the traditional operative approach of complete removal of caries is steadily losing support due to successful results with materials of high microleakage resistance. Treatment time and pain control in asymptomatic teeth has always been a problem in children. Hall technique is a minimally invasive treatment protocol that doesn’t require local anesthesia, use of rotating devices for caries removal to restore primary teeth with SSC. But this protocol also raised questions in the scientific community about its possible effects on the dentition and temporomandibular joint (TMJ) for causing primary occlusal contact and increasing vertical dimension. Preformed metal crowns (PMCs) have high success rates in restoring primary molars in children but they were not generally used by dentists, especially in developing countries due to its demand of high clinical skills with the conventional technique (CT). The biological approach, Hall technique (HT), requires less training and can be placed by less experienced dental operators including therapists. Previous studies were mainly carried out in developed countries. The aims were to investigate and compare the efficacies and cost-effectiveness of preformed stainless steel and flexible esthetic crowns The purpose of this study is to compare the effectiveness of the flexible esthetic crown to the conventional Stainless-Steel Crown restoration by various techniques in the treatment of primary molars with dentinal caries with or without proximal ridge intact. |