| CTRI Number |
CTRI/2019/02/017603 [Registered on: 12/02/2019] Trial Registered Prospectively |
| Last Modified On: |
08/02/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Estimation of bone loss around two different collar implants |
|
Scientific Title of Study
|
Evaluation of crestal bone loss and implant stability between two different crest module implants |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dhopathi Sravya Reddy |
| Designation |
Post graduate |
| Affiliation |
KAMINENI INSTITITE OF DENTAL SCIENCES |
| Address |
KAMINENI INSTITITE OF DENTAL SCIENCES,Department of periodontics, Room no. 211, NARKETPALLY,SREEPURAM, NALGONDA. TELANGANA.
KAMINENI INSTITITE OF DENTAL SCIENCES,Department of periodontics, Room no. 211, NARKETPALLY,SREEPURAM, NALGONDA. TELANGANA. 508254
Nalgonda
TELANGANA
508254
India |
| Phone |
9676650799 |
| Fax |
|
| Email |
shravya94@icloud.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Guntakandla Vikram Reddy |
| Designation |
MDS |
| Affiliation |
KAMINENI INSTITITE OF DENTAL SCIENCES |
| Address |
KAMINENI INSTITITE OF DENTAL SCIENCES,SREEPURAM,Department of periodontics,Room no.211,NARKETPALLY, NALGONDA. TELANGANA. 508254
KAMINENI INSTITITE OF DENTAL SCIENCES,NARKETPALLY,SREEPURAM, NALGONDA. TELANGANA. 508254
Nalgonda
TELANGANA
508254
India |
| Phone |
9676650799 |
| Fax |
|
| Email |
vikramreddydr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DSravya Reddy |
| Designation |
Post graduate |
| Affiliation |
KAMINENI INSTITITE OF DENTAL SCIENCES |
| Address |
KAMINENI INSTITITE OF DENTAL SCIENCES,Department of periodontics, Room no.211, NARKETPALLY,SREEPURAM, NALGONDA. TELANGANA. 508254
KAMINENI INSTITITE OF DENTAL SCIENCES,NARKETPALLY,SREEPURAM, NALGONDA. TELANGANA. 508254
Nalgonda
TELANGANA
508254
India |
| Phone |
9676650799 |
| Fax |
|
| Email |
shravyareddy0204@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sravya Reddy |
| Address |
KAMINENI INSTITITE OF DENTAL SCIENCES,NARKETPALLY,SREEPURAM, NALGONDA |
| 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 |
| DSravya reddy |
Kamineni institute of dental sciences |
Kamineni institute of dental sciences,Department of periodontics, Room no.211, Sreepuram, Narketpally, Nalgonda-508254
Nalgonda
TELANGANA |
9676650799
Shravya94@icloud.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee, Kamineni institute of dental sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Edentulous sites |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group(C) : 12 sites receiving machined collar crest module designed implants
|
Crestal bone level and implant stability will be recorded using peri apical radiographs and device PENGUINRFA at baseline, 4 weeks, and 12 weeks. |
| Intervention |
Test Group(T) : 12 sites receiving smooth collar crest module designed implants
|
Crestal bone level and implant stability will be recorded using peri apical radiographs and device PENGUINRFA at baseline, 4 weeks, and 12 weeks. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Patients with single or multiple edentulous areas with an age range between 20-55 years |
|
| ExclusionCriteria |
| Details |
Pregnant women and lactating mothers, Patients on medication which effects bone metabolism. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Crestal bone level and implant stability will be recorded |
Crestal bone level and implant stability will be recorded using peri apical radiographs and device PENGUINRFA at baseline, 4 weeks, and 12 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Crestal bone level and implant stability is recorded using peri-apical radiographs and device penguin to measure RFA values |
baseline, 1month, 3months |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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/ Phase 2 |
|
Date of First Enrollment (India)
|
12/02/2019 |
| 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="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
RADIOGRAPHIC EVALUATION OF CRESTAL BONE LOSS AND IMPLANT STABILITY USING RFA DEVICE BETWEEN TWO DIFFERENT CREST MODULE IMPLANTS |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Patients will be
selected from outpatient department of Periodontics, Kamineni Institute Of
Dental Sciences, Narketpally, and Nalgonda. Selected patients
aged between 20-55 years of age and Patients
with single or multiple edentulous areas are selected to evaluate crestal bone loss and implant stability between two different crest module designs. |