| CTRI Number |
CTRI/2024/04/065637 [Registered on: 15/04/2024] Trial Registered Prospectively |
| Last Modified On: |
12/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A clinical study to evaluate the gum changes, bone level around dental implants by use of membrane from blood and Frozen membrane from blood |
|
Scientific Title of Study
|
Comparative evaluation of Soft tissue changes, pink esthetic scores, marginal bone level and patient reported outcomes on adjunctive use of A-PRF and frozen A-PRF in delayed implant placement – A randomized 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 |
Dr Arimanda Prithvi |
| Designation |
I MDS Post graduate student |
| Affiliation |
Vishnu Dental College |
| Address |
Room no 7,Block 2, Department of Periodontics and Implantology, Vishnu Dental College, Vishnupur, Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9491976226 |
| Fax |
|
| Email |
drprithvireddy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K S V RAMESH |
| Designation |
Associate professor |
| Affiliation |
Vishnu Dental College |
| Address |
Room no.7,Block 2 Department of Periodontics and Implantology, Vishnu Dental College, Vishnupur, Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
8886157669 |
| Fax |
|
| Email |
rameshksv@vdc.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr M Satyanarayana Raju |
| Designation |
Professor |
| Affiliation |
Vishnu Dental College |
| Address |
Room no.8,Block 2 Department of Prosthodontics, Vishnu Dental College, Vishnupur, Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9492293809 |
| Fax |
|
| Email |
satya@vdc.edu.in |
|
|
Source of Monetary or Material Support
|
| Vishnu Dental College, Vishnupur, Bhimavaram - 534202 |
|
|
Primary Sponsor
|
| Name |
Dr. Arimanda Prithvi |
| Address |
Room no 7,Block 2, Department of Periodontics and Implantology, Vishnu Dental College, Vishnupur, Bhimavaram |
| 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 |
| Dr Arimanda Prithvi |
Vishnu Dental College |
Room no 7,Block 2, Department of Periodontics and Implantology, Vishnu Dental College, Vishnupur, Bhimavaram
West Godavari
ANDHRA PRADESH |
9491976226
drprithvireddy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Vishnu Dental COllege |
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 |
| Intervention |
A-PRF |
A PRF will be prepared from patients venous blood collected, and centrifuged at 1300 rpm. The implant will be placed followed by the placement of A-PRF around the implant and flaps will be approximated using sutures. Clinical evaluation of Papillary height, thickness of peri implant mucosa, width of peri-implant mucosa will be measured at baseline,3months, 6months. Pink esthetic score will be measured at baseline,1 month,3 months. Implant stability will be measured at baseline and 3months, peri implant marginal bone loss will be measured at baseline,3months, 6months, wound healing at 14 days, 1 month, 3months and patient satisfaction questionnaire will be recorded. |
| Comparator Agent |
conventional implants |
The implant will be placed and flaps will be approximated using sutures. Clinical evaluation of Papillary height, thickness of peri implant mucosa, width of peri-implant mucosa will be measured at baseline,3months, 6months. Pink esthetic score will be measured at baseline,1 month,3 months. Implant stability will be measured at baseline and 3months, peri implant marginal bone loss will be measured at baseline,3months, 6months, wound healing at 14 days, 1 month, 3months and patient satisfaction questionnaire will be recorded. |
| Intervention |
Frozen A-PRF |
Frozen A PRF will be prepared from patients venous blood collected, and centrifuged at 1700 rpm and frozen for 24hrs at -19 degree centigrade. The implant will be placed followed by the placement of A-PRF around the implant and flaps will be approximated using sutures. Clinical evaluation of Papillary height, thickness of peri implant mucosa, width of peri-implant mucosa will be measured at baseline,3months, 6months. Pink esthetic score will be measured at baseline,1 month,3 months. Implant stability will be measured at baseline and 3months, peri implant marginal bone loss will be measured at baseline,3months, 6months, wound healing at 14 days, 1 month, 3months and patient satisfaction questionnaire will be recorded. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
68.00 Year(s) |
| Gender |
Both |
| Details |
1 FMPS, FMBS less than 20%
2 D2,D3 bone
3 Patients requiring implant in mandibular posterior region |
|
| ExclusionCriteria |
| Details |
1 Patients with platelet disorders (thrombocythemia, thrombocytopenia)
2 Patients under anti- coagulants3
3 Patients with uncontrolled systemic diseases
4 Patients with para functional habits
5 Pregnant and lactating women
6 Patients under chemotherapy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 Papillary height
2 thickness of peri-implant mucosa
3 Width of peri-implant mucosa
4 Peri implant marginal bone loss |
1 Papillary height and thickness of peri-implant mucosa at baseline,1 month 3 month
3 Width of peri-implant mucosa at baseline,3months,6months
4 Peri implant marginal bone loss at baseline 3months 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Implant stability
2 pink esthetic scores
3 Wound healing
4 Patient satisfaction questionnaire |
1 Implant stability at baseline,3 months,6 months
2 pink esthetic score at baseline,1 month 3 months
2 wound healing at 14 days,1 month,3 months
3 patient satisfication questionnaire |
|
|
Target Sample Size
|
Total Sample Size="27"
Sample Size from India="27"
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)
|
24/04/2024 |
| 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="1"
Months="6"
Days="28" |
|
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
|
The study is to evaluate and compare the pink esthetic scores, peri implant soft tissue changes, marginal bone level ,wound healing, patient satsification and implant stability by adjunctive use of A-PRF and Frozen A-PRF and a total of 27 subjects with mandibular partial edentulous area will be recruited from out patient department of periodontics and implantology and will be assigned into 3 groups of 9 in each where in control group conventional implant placement and approximations of flaps using sutures will be done .In test group 1 conventional implant placement with A-PRF membrane will be placed and approximations of flaps using sutures will be done.In test group 2 conventional implant placement with Frozen A-PRF membrane will be placed and approximations of flaps using sutures will be done and in all the three groups Pink Esthetic Score at baseline,1month,3 months ,papillary height, thickness of peri implant mucosa ,width of peri implant mucosa ,peri implant marginal bone loss at baseline,3 months,6months ,implant stability at base line 3 months and wound healing at 14 days,1 month,3 months and patient satisfication questionnaire are evaluated .The data will be analyzed individually for all the patients.There is no conflict of intreset |