| CTRI Number |
CTRI/2022/11/047159 [Registered on: 09/11/2022] Trial Registered Prospectively |
| Last Modified On: |
09/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the strength of the dental implant and to check the bone loss in human blood component treated with titanium and normal implants |
|
Scientific Title of Study
|
A Comparative evaluation of implant stability and crestal bone loss in T-PRF (titanium platelet rich fibrin) treated and conventional implants - A split mouth 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 |
Thotimpuri Anuraga Tejaswi |
| Designation |
Mds Post Graduate Student |
| Affiliation |
Vishnu Dental College |
| Address |
ROOM No:7 Department of Periodontics and Implantology
Vishnu Dental College Vishnupur,Bhimavaram-534202
West Godavari district-AP
pin code-534202
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
8328268839 |
| Fax |
|
| Email |
anurag.teju@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohan Kumar P |
| Designation |
Associate Professor |
| Affiliation |
Vishnu Dental College |
| Address |
ROOM No:7 Department of Periodontics and Implantology
Vishnu Dental College Vishnupur,Bhimavaram-534202
West Godavari district-AP
pin code-534202
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
7799411140 |
| Fax |
|
| Email |
mosups@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohan Kumar P |
| Designation |
Associate Professor |
| Affiliation |
Vishnu Dental College |
| Address |
ROOM No:7 Department of Periodontics and Implantology
Vishnu Dental College Vishnupur,Bhimavaram-534202
West Godavari district-AP
pin code-534202
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
7799411140 |
| Fax |
|
| Email |
mosups@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vishnu Dental College,
Bhimavaram |
|
|
Primary Sponsor
|
| Name |
THOTIMPURI ANURAGA TEJASWI |
| Address |
ROOM NO :7 Department of Periodontics and Implantology, Vishnu Dental College,
Vishnupur, Bhimavaram-534202
West Godavari District-AP
Pin code-534202 |
| 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 |
| Thotimpuri Anuraga Tejaswi |
Vishnu Dental College |
ROOM NO :7 Department of Periodontics and Implantology, Vishnu Dental College,
Vishnupur,Bhimavaram-534202
West Godavari District-AP
Pin code-534202
West Godavari
ANDHRA PRADESH |
8328268839
anurag.teju@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: K084||Partial loss of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard Dental implants |
Standard Dental implants are the conventional method of replacing missing teeth, osteointegration and BIC will occur naturally without any enhancers for implant stability.
Duration: Duration time for comparator agent is 30 minutes |
| Intervention |
T-PRF (Titanium platelet rich fibrin) |
Titanium Activated PRF (T-PRF) which belongs to 3rd generation that was introduced by Tunali et al in 2014.
T -PRF is centrifuged in titanium tubes which is more effective in activating the platelets than the glass tubes by using Chouckroun’s method.
Titanium is passivated into an oxide layer within itself, which activates platelets and forms a thicker fibrin clot. In addition to the above benefits, T-PRF also has longer resorption time 5, thicker fibrin meshwork and higher cellular entrapment causing more cellularity at the required site.6 Though there is a vast literature showing osteointegration, BIC and implant stability using various platelet rich concentrates, till to date no literature was available regarding the usage of T-PRF in implants (in vivo). Therefore, the main aim of this prospective randomized controlled clinical trial is to evaluate and compare the effect of T-PRF on implant stability in T-PRF treated and conventional implant placements.
Duration: Duration time for intervention is 45 minutes
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
•Patients of age 20-65 years of age.
•Patients with missing mandibular posterior teeth.
|
|
| ExclusionCriteria |
| Details |
•Patients with severe systemic illness
•Postmenopausal women who are under hormonal
replacement therapy
•Patients under anticoagulants, statins
•Pregnant women
•Lactating women
•Smokers
•Patients under chemotherapy
•Patients under bisphosphonate therapy
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
-Stability of T-PRF treated standard dental implants using RFA (resonance frequency analysis).
|
-Stability of T-PRF treated standard dental implants using RFA (resonance frequency analysis) at baseline and 3 months.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
-Crestal bone loss evaluation by using RVG (Radiovisiography)
|
-Crestal bone loss evaluation by using RVG (Radiovisiography) at baseline,3months and 6months respectively
|
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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 4 |
|
Date of First Enrollment (India)
|
15/11/2022 |
| 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="6"
Days="10" |
|
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)?
Response - NO
|
|
Brief Summary
|
Patients with mandibular missing teeth and wants to fix them visiting Vishnu dental college are taken into consideration, patients who are in inclusive criteria are taken into consideration and a return informed consent is taken before starting a procedure, patients divided into control and test group,in control group 4.5x10 standard implants will be placed in patients with mandibular posterior missing teeth,in test group Group B (Test group) (4.5X10mm) T-PRF treated implants will be placed in patients with mandibular posterior missing teeth.After implant placements Clinical evaluation of primary stability by using RFA (Resonance frequency analyser) at baseline and 3months and evaluation of crestal bone loss will be done by using RVG (Radiovisiography) at baseline,3months,6months respectively. |