| CTRI Number |
CTRI/2018/05/013713 [Registered on: 07/05/2018] Trial Registered Prospectively |
| Last Modified On: |
05/05/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Platelet Rich Fibrin on healing around implants |
|
Scientific Title of Study
|
Evaluation of soft tissue and crestal bone changes around non-submerged implants with and without Platelet rich fibrin |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Drcheruvu ramya naga shivani |
| Designation |
post graduate |
| Affiliation |
sibar institute of dental sciences |
| Address |
sibarinstitute of dental sciencs,
takkellapadu,
guntur
sibar institute of dental sciences
takkellapadu
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9492742313 |
| Fax |
|
| Email |
cheruvushivani93@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr kishore kumar katuri |
| Designation |
professor |
| Affiliation |
sibar institute of dental sciences |
| Address |
sibarinstitute of dental sciencs,
takkellapadu,
guntur
sibar institute of dental sciences
takkellapadu
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9000534590 |
| Fax |
|
| Email |
kishorekaturi183@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Drcheruvu ramya naga shivani |
| Designation |
post graduate |
| Affiliation |
sibar institute of dental sciences |
| Address |
sibarinstitute of dental sciencs,
takkellapadu,
guntur
sibar institute of dental sciences
takkellapadu
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9492742313 |
| Fax |
|
| Email |
cheruvushivani93@gmail.com |
|
|
Source of Monetary or Material Support
|
| dept of periodontics,
sibar institute of dental sciences
takkellapadu
guntur
andhra pradesh
522509
India. |
|
|
Primary Sponsor
|
| Name |
sibar institute of dental sciences |
| Address |
SIBAR INSTITUTE OF DENTAL SCIENCES
TAKKELLAPADU
GUNTUR |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| sibar institute of dental sciences |
takkellapadu
guntur |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| dr cheruvu ramya naga shivani |
dept of periodontics |
room no: 8,
sibar institute of dental sciences
takkellapadu
Guntur
ANDHRA PRADESH |
9492742313
cheruvushivani93@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| sibar institute of dental sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
EDENTULOUS POSTERIOR MANDIBULAR AREA |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
"Evaluation of soft tissue and crestal bone changes around non-submerged implants with and without Platelet rich fibrin" |
platelet rich fibrin(PRF) is prepared by taking 10ml from patient venous blood and centrifuged for 5 mts at 2700 rpm. obtained gel is seperated from RBC and squeezed to make it as a membrane.it is placed around the implant and flap is approximated with sutures. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. individuals with need of tooth replacement
2. should have sufficient amount of bone in the receipient site to allow implant installation without implentation of ridge augmentation procedures |
|
| ExclusionCriteria |
| Details |
1. under any medications
2. unable to performoral hygeine measures
3. medically compromised
4. parafunctional habits
5. tobacco use |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to determine hard tissue changes around implants |
baseline,3 months,6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to determine soft tissue changes around implants |
all the parameters will be asessed at 3months,and 6 months postoperatively |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
N/A |
|
Date of First Enrollment (India)
|
07/05/2018 |
| 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="5"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
total of 40 healthy individuals with having mandibular edentulous areas were divided randomly into 2 groups with 20 in each group. modified plaque index, gingival index, width of keratinized tissue, thickness of keratinized tissue, radigraphic bone level using iopa will be measured at baseline,3 months and 6 months postoperatively. group I patients are treated with implant placed along with PRF membrane whereas in group implants alone will be placed. at 3 months postoperatively restoration of implants is done in both the groups. data will be correllated between the two groups at each interval to evaluate the use of placement of PRF membrane in healing. |