| CTRI Number |
CTRI/2024/05/068018 [Registered on: 29/05/2024] Trial Registered Prospectively |
| Last Modified On: |
27/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To test if a special mixture of patients blood and titanium can make dental implants stick better to jaw bone. |
|
Scientific Title of Study
|
Effect of titanium-prepared platelet-rich fibrin on osseointegration of dental implants – a randomized controlled clinical trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prakruti Murthy |
| Designation |
PG student |
| Affiliation |
Shri Dharmasthala Manjunatheswhara university |
| Address |
Department of Periodontics, Room no.7, Shri Dharmasthala Manjunatheswhara College of Dental Sciences and Hospital Sattur
Dharwad
KARNATAKA
580009
India |
| Phone |
7259165767 |
| Fax |
|
| Email |
prakrutimurthy99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mihir Kulkarni |
| Designation |
MDS Associate Professor |
| Affiliation |
Shri Dharmasthala Manjunatheswhara university |
| Address |
Department of Periodontics, Room no.7, Shri Dharmasthala Manjunatheswhara College of Dental Sciences and Hospital dhavalnagar Sattur
Dharwad
KARNATAKA
580009
India |
| Phone |
9886484039 |
| Fax |
|
| Email |
mihir.mrk271@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mihir Kulkarni |
| Designation |
MDS Associate Professor |
| Affiliation |
Shri Dharmasthala Manjunatheswhara university |
| Address |
Department of Periodontics, Room no.7, Shri Dharmasthala Manjunatheswhara College of Dental Sciences and Hospital Sattur
Dharwad
KARNATAKA
580009
India |
| Phone |
9886484039 |
| Fax |
|
| Email |
mihir.mrk271@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Periodontics, Room no.7, Shri Dharmasthala Manjunatheshwara College of Dental Science and Hospital Sattur,Dharwad, Karnataka, India, 580009 |
|
|
Primary Sponsor
|
| Name |
Prakruti Murthy |
| Address |
Department of Periodontics, Room no.7, Shri Dharmasthala Manjunatheshwara College of Dental Sciences and Hospital Sattur, Dharwad, Karnataka, India, 580009 |
| Type of Sponsor |
Other [self sponsor ] |
|
|
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 Prakruti Murthy |
Shri Dharmasthala Manjunatheshwara Dental hospital |
Department of implantology, Room no.3, Shri Dharmasthala Manjunatheshwara College of Dental Sciences and Hospital Sattur
Dharwad
KARNATAKA |
7259165767
prakrutimurthy99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDM College of Dental Sciences and Hospital - IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K068||Other specified disorders of gingiva and edentulous alveolar ridge, , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
control group |
In control group implant placement will be done at osteotomy site followed by recording ISQ values at baseline, 6 weeks and 12 weeks |
| Intervention |
T-PRF group |
In study group implant placement will be done after placing titanium prepared platelet rich fibrin in osteotomy site followed by recording the ISQ values at baseline, 6 weeks, 12 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Systemically healthy patients.
2.Patients requiring single implant-supported restorations at well-healed sites.
3.Presence of adequate interocclusal space as well as mesio-distal space at the edentulous sites.
4.Presence of adequate bone width and height to support an appropriately sized implant to replace the missing tooth.
5.Implant insertion is done at a minimum insertion torque of 25 NCm and a minimum ISQ of 60.
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the implant stability quotient between T-PRF and control group |
3-4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To evaluate the effect of T-PRF on the peri-implant soft tissue thickness
2.To evaluate the effect of T-PRF on the peri-implant alveolar crest levels.
3.To evaluate the effect of T-PRF on the keratinized tissue width
|
3-4 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
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/06/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Participant blood will be collected and processed into T-PRF using titanium tubes. Implants will be placed with or without T-PRF, ISQ values measured, and tissue parameters assessed over 12 weeks, including radiographic evaluation for bone changes. |