CTRI Number |
CTRI/2023/10/058547 [Registered on: 12/10/2023] Trial Registered Prospectively |
Last Modified On: |
15/04/2025 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Dentistry |
Study Design |
Other |
Public Title of Study
|
comparison between 3D printed space maintainer and prefabricated stainless steel space maintainer |
Scientific Title of Study
|
Comparative evaluation of clinical performance of 3D printed space maintainer using PEEK polymer with that of prefabricated stainless steel space maintainer-An In-vivo study |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
JAHANA SHERIN IM |
Designation |
postgraduate student |
Affiliation |
YENEPOYA DENTAL COLLEGE |
Address |
DERALAKATTE MANGALORE KARNATAKA 575018
Dakshina Kannada KARNATAKA 575018 India |
Phone |
9447131656 |
Fax |
|
Email |
jahanasherinim656@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
JAHANA SHERIN IM |
Designation |
PG STUDENT |
Affiliation |
YENEPOYA DENTAL COLLEGE |
Address |
DERALAKATT MANGALORE KARNATAKA 575018
Dakshina Kannada KARNATAKA 575018 India |
Phone |
9447131656 |
Fax |
|
Email |
jahanasherinim656@gmail.com |
|
Details of Contact Person Public Query
|
Name |
JAHANA SHERIN IM |
Designation |
PG STUDENT |
Affiliation |
YENEPOYA DENTAL COLLEGE |
Address |
DERALAKATT MANGALORE KARNATAKA 575018
Dakshina Kannada KARNATAKA 575018 India |
Phone |
9447131656 |
Fax |
|
Email |
jahanasherinim656@gmail.com |
|
Source of Monetary or Material Support
|
YENEPOYA INCUBATION CENTRE,YENEPOYA DENTAL COLLEGE |
|
Primary Sponsor
|
Name |
JAHANA SHERIN IM |
Address |
DEPT. OF PEDIATRIC AND PREVENTIVE DENTISTRY,
YENEPOYA DENTAL COLLEGE, DERLAKATTE, MANGALORE, KARNATAKA, 575018 |
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 AJAY RAO HT |
YENEPOYA DENTAL COLLEGE MANGALORE |
Department of Pediatric and Preventive Dentistry, Yenepoya Dental College, DERALAKATTE Mangalore KARNATAKA Dakshina Kannada KARNATAKA |
9845085048
drajayrao@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
YENEPOYA ETHICS COMMITTEE 2 |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: K084||Partial loss of teeth, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
NA |
NA |
Intervention |
SPACE MAINTAINER |
FABRICATION OF SPACE MAINTAINER, TO MAINTAIN THE SPACE CREATED BY LOSS OF PRIMARY TEETH UNTIL THE ERUPTION OF PERMANENT TEETH
Duration-until the eruption of permanent teeth
frequency-The appliance is provided only once,in case of any damage appliance will be replaced.
follow up check up will be done once in 6 months |
|
Inclusion Criteria
|
Age From |
6.00 Year(s) |
Age To |
9.00 Year(s) |
Gender |
Both |
Details |
Children of age group 6-9 years with two posterior edentulous spaces due to premature loss of deciduous molars and indicated for space maintainer |
|
ExclusionCriteria |
Details |
Medically compromised patients
Patients with high caries index
Children with dental abnormalities (cross bite/open bite/deep bite)
Children with loss of space |
|
Method of Generating Random Sequence
|
Other |
Method of Concealment
|
Other |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
CLINICAL SUCCESS RATE OF 3D PRINTED SPACE MAINTAINER AND PREFABRICATED SPACE MAINTAINER IN PEDIATRIC DENTISTRY INTERMS OF PLAQUE INDEX, GINGIVAL INDEX, RETENTION AND SURVIVAL TIME |
6 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
CLINICAL SUCCESS RATE OF 3D PRINTED SPACE MAINTAINER AND PREFABRICATED SPACE MAINTAINER IN PEDIATRIC DENTISTRY INTERMS OF PATIENTS SATISFACTION USING VISUAL ANALOGUE SCALE |
end of 6 months |
|
Target Sample Size
|
Total Sample Size="15" Sample Size from India="15"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
Phase of Trial
|
Phase 2 |
Date of First Enrollment (India)
|
20/10/2023 |
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="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
review and case report publication in malabar dentist-IDA journal malabar branch,kerala-2025-jan-march edition |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The study’s aim is to compare and evaluate the clinical performance of 3D printed space maintainer using PEEK polymer with that of prefabricated stainless steel space maintainer. The result of the study will give additional information regarding the potential use of PEEK polymer material in fabrication of space maintainer. It is an in-vivo experimental study with 15 children of age group 6-9 years reporting to dept. of pediatric and preventive dentistry, Yenepoya Dental College, who has two posterior edentulous spaces and indicated for space maintainers. The study will be commenced only after approval from the institutional ethical committee. Once inclusion and exclusion criteria are satisfied consent from parents and child will be obtained prior to the study. Impressions of upper and lower arch will be made using rubber-based impression material and then Casts will be poured. The cast will be sent to 3D lab at Yenepoya Incubation Centre for the fabrication of 3D space. And then the appliance will be sterilized according to standard sterilization protocol. Prefabricated space maintainer will be adapted on one edentulous space according to user instructions and 3D designed space maintainer using PEEK will be fixed on the other edentulous space. Both the space maintainers will be luted by using resin modified GIC. All the procedure will be carried out by single operator. At the end of 6 months, patient will be recalled and parameters like plaque index, gingival index, survival time, patient satisfaction will be evaluated and documented. The above results will be subjected to statistical analysis. |