CTRI Number |
CTRI/2020/11/029271 [Registered on: 20/11/2020] Trial Registered Prospectively |
Last Modified On: |
13/11/2020 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Dentistry |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Comparative evaluation of the survival rate and gingival health of 3D printed band and loop space maintainer with conventional band and loop space maintainer in children |
Scientific Title of Study
|
Comparative evaluation of the survival rate and gingival health of 3D printed vs. conventional band and loop space maintainers in children |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
G L G S PRUDHVI KUMAR |
Designation |
Post Graduate Student |
Affiliation |
GSL Dental College and Hospital |
Address |
Room no 8
Department of Pediatric and Preventive Dentistry
GSL Dental College and Hospital
NH 16
Jagannadhapuram Agraharam
Lakshmipuram
Rajahamundry
East Godavari ANDHRA PRADESH 533296 India |
Phone |
9398850377 |
Fax |
|
Email |
prudhvi.gannamani@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Veena Arali |
Designation |
Professor and HOD |
Affiliation |
GSL Dental College and Hospital |
Address |
Room no - 8
Department of Pediatric and Preventive Dentistry
GSL Dental College and Hospital
NH - 16
Jagannadhapuram Agraharam
Lakshmipuram
Rajahamundry
East Godavari ANDHRA PRADESH 533296 India |
Phone |
7760748787 |
Fax |
|
Email |
gslpedo@gmail.com |
|
Details of Contact Person Public Query
|
Name |
G L G S PRUDHVI KUMAR |
Designation |
Post Graduate Student |
Affiliation |
GSL Dental College and Hospital |
Address |
Room no 8
Department of Pediatric and Preventive Dentistry
GSL Dental College and Hospital
NH 16
Jagannadhapuram Agraharam
Lakshmipuram
Rajahamundry
East Godavari ANDHRA PRADESH 533296 India |
Phone |
9398850377 |
Fax |
|
Email |
prudhvi.gannamani@gmail.com |
|
Source of Monetary or Material Support
|
Department of Pediatric and Preventive Dentistry
GSL Dental College and Hospital
Rajahmundry |
|
Primary Sponsor
|
Name |
nil |
Address |
nil |
Type of Sponsor |
Other [nil] |
|
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 |
G L G S PRUDHVI KUMAR |
Department of Pediatric and Preventive Dentistry |
room no 8
Department of Pediatric and Preventive Dentistry
GSL Dental College and Hospital
NH 16
Jagannadhapuram Agraharam
Lakshmipuram
Rajahamundry
East Godavari ANDHRA PRADESH |
9398850377
prudhvi.gannamani@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: K006||Disturbances in tooth eruption, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
3D printed band and loop Space Maintainer |
3D printed metal band and loop space maintainer
easy to fabricate
less time consuming
more efficient
no need for impressions
good patient cooperation
easily acceptable by children
|
Comparator Agent |
conventional band and loop space maintainer |
conventional space maintainer
is cost effective
traditionally followed
high success rate
|
|
Inclusion Criteria
|
Age From |
4.00 Year(s) |
Age To |
9.00 Year(s) |
Gender |
Both |
Details |
Patients in the age group of 4 to 9 years.
Extraction sites or teeth indicated for extraction with no space loss.
Erupting permanent teeth having adequate bone covering.
Fully erupted carious free teeth, will be included in the study.
|
|
ExclusionCriteria |
Details |
Patients not in the age group of 4 to 9 years.
teeth not indicated for extraction.
extraction sites with space loss.
permanent teeth having non adequate bone covering.
partially erupted carious teeth |
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
Alternation |
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
3D printed band and loop space maintainer will have a better survival rate and gingival health compared to conventional band and loop space maintainer in children
|
9 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
There is no significant difference between survival rate and gingival health of 3D printed vs. conventional band and loop space maintainers in children |
9 months |
|
Target Sample Size
|
Total Sample Size="20" Sample Size from India="20"
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 1 |
Date of First Enrollment (India)
|
01/12/2020 |
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="0" Months="9" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
The present in vivo study aimed to compare 3D printed vs. conventional band and loop Space Maintainers(SM) and evaluate their survival rate and gingival health in children and to obtain results for which is the best Space maintainer in terms of survival rate and gingival health by including 20 patients of age 4 to 9 years with 20 extraction sites will be selected after obtaining written informed consent from the parents of the child. And the two types of BAND &LOOP SM will be fabricated and will be divided into two groups Group I(n=10) - CONVENTIONAL BAND &LOOP SM, Group II(n=10) – 3D BAND &LOOP SM. A brief history will be recorded, and clinical examination will be done, Intraoral periapical radiographs will be taken in areas of tooth loss, Study models will be prepared, and space analysis will be carried out for every child, For every selected child, oral prophylaxis will be done before placement of a space maintainer and a conventional band and loop will be fabricated according to the technique described by Finn, and for 3D printed space maintainer edentulous space will be scanned using a 3D digital dental scanner followed by the designing of the band and loop similar to the conventional SM, on computer and fabrication will be done using a 3D printer with the material ABS. Both the types of space maintainers will be luted to the teeth in both the groups using type I Glass Ionomer Cement. Instructions for oral hygiene and appliance maintenance will be given to children and their parents. Patients will be recalled at 3rd and 6th months for evaluation of space maintainers using the criteria for assessing survival rate and gingival health. The results obtained from the criteria mentioned above will be tabulated accordingly and evaluated for statistical significance. The data collected at the 3rd and 6th months will be subjected to statistical analysis.
|