| CTRI Number |
CTRI/2020/09/027578 [Registered on: 03/09/2020] Trial Registered Prospectively |
| Last Modified On: |
02/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A-Prf and L-Prf comparision on dental implants osseointegration |
|
Scientific Title of Study
|
Comparitive evaluation Of A-prf and L-prf on osseointegration of dental implants:A bio-clinical and radiological study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrBETAPUDI TEJASWINI |
| Designation |
PG |
| Affiliation |
St.Joseph dental college |
| Address |
TEJASWINI D/O RAJU
st.joseph dental college
DUGGIRALA
ELURU
West Godavari
ANDHRA PRADESH
534003
India |
| Phone |
9491124793 |
| Fax |
|
| Email |
betapuditejaswini@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mandalapu Narendra Babu |
| Designation |
Professor |
| Affiliation |
St.Joseph dental college |
| Address |
Tejaswini D/O Raju
st.joseph dental college
Duggirala
Eluru
West Godavari
ANDHRA PRADESH
534003
India |
| Phone |
9491124793 |
| Fax |
|
| Email |
plaque3456@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrBETAPUDI TEJASWINI |
| Designation |
PG |
| Affiliation |
St.Joseph dental college |
| Address |
TEJASWINI D/O RAJU
st.joseph dental college
DUGGIRALA
ELURU
West Godavari
ANDHRA PRADESH
534003
India |
| Phone |
9491124793 |
| Fax |
|
| Email |
betapuditejaswini@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPATMENT OF PERIODONTICS
ST.JOSEPH DENTAL COLLEGE |
|
|
Primary Sponsor
|
| Name |
department of periodontics |
| Address |
st.Joseph dental college |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Tejaswini Betapudi |
department of periodontics |
room no 08
West Godavari
ANDHRA PRADESH |
9491124793
betapuditejaswini@gmail.com |
| betapudi tejaswini |
st.joseph dental college |
department of periodontics,
room no 8
West Godavari
ANDHRA PRADESH |
9491124793
betapuditejaswini@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional ethical committee |
No Objection Certificate |
|
|
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 |
| Intervention |
A PRF AND L PRF |
prf from 10ml blood,
route of administration is osteotomy site,
duration of therapy is 6months |
| Comparator Agent |
A prf and L prf |
prf from 10ml blood, route of administration is osteotomy site, duration of therapy is 6months |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of mean age group between 20 to 55 years either male or female.
2.Patients with two or more edentulous site in either maxilla or mandible.
3.Good systemic health.
|
|
| ExclusionCriteria |
| Details |
1.Any systemic disease that affects the Periodontium are contraindicated for implant placement.
2.Patients with psychiatric disorders.
3.Patients on any medication that could effect or alter the course of periodontal treatment.
4.Inability or unwillingness to complete the trial
5.Poor oral hygiene
6.Pregnant, lactating mothers.
7.History of smoking and alcohol. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| study under trail |
Patient will be assessed at baseline and 6months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| OSSEOINTEGRATION AND ALKALINE PHOSPHATASE LEVELS |
6MONTHS |
|
|
Target Sample Size
|
Total Sample Size="14"
Sample Size from India="14"
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)
|
07/09/2020 |
| 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="1"
Months="1"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Study under clinical trail,not yet published. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Patients
in mean age group between 20 to 55 years will be randomly selected for double-blind clinical trial. A-PRF will be placed in 10 implant sites and L-PRF will
be placed in 10 implant sites. All the patients will be evaluated for
osseointegration and levels of alkaline phosphatase at implant sites by using
CBCT and Alkaline phosphatase level after placement of A-PRF and L-PRF at
implant sites. |