| CTRI Number |
CTRI/2024/11/077058 [Registered on: 19/11/2024] Trial Registered Prospectively |
| Last Modified On: |
15/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
"Assessing the Effectiveness of bio-material in Improving Implant Stability and Bone Health: A Clinical Study" |
|
Scientific Title of Study
|
Evaluating the efficacy of application of i-prf on implant stability and marginal bone levels: A randomized clinical study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jyothi Prasanna Paritala |
| Designation |
Post Graduate |
| Affiliation |
GSL Dental College and Hospital |
| Address |
Room no:10,Department of Periodontics, GSL Dental College, Rajahmundry, Andhra Pradesh, India,533296
East Godavari
ANDHRA PRADESH
533296
India |
| Phone |
8309177116 |
| Fax |
|
| Email |
jyothiprasannaparitala@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Anupama Masapu |
| Designation |
Professor & Head of the Department |
| Affiliation |
GSL Dental College and Hospital |
| Address |
Room no:10,Department of Periodontics, GSL Dental College, Rajanagaram, Rajahmundry, Andhra Pradesh, India,533296
East Godavari
ANDHRA PRADESH
533296
India |
| Phone |
9985313267 |
| Fax |
|
| Email |
anu3267@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Jyothi Prasanna Paritala |
| Designation |
Post Graduate |
| Affiliation |
GSL Dental College and Hospital |
| Address |
Room no:10,Department of Periodontics, GSL Dental College, Rajahmundry, Andhra Pradesh, India,533296
East Godavari
ANDHRA PRADESH
533296
India |
| Phone |
8309177116 |
| Fax |
|
| Email |
jyothiprasannaparitala@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Jyothi Prasanna Paritala |
| Address |
Room no:10,Department of Periodontics, GSL Dental College ,Rajanagaram , Rajahmundry, Andhra Pradesh, India,533296 |
| 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 Jyothi Prasanna Paritala |
GSL Dental College |
Room no:10,Department of Periodontics, GSL Dental College and Hospital, Rajanagaram, Rajahmundry, Andhra Pradesh, India,533296
East Godavari
ANDHRA PRADESH |
8309177116
jyothiprasannaparitala@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GSL Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: K084||Partial loss of teeth, (2) ICD-10 Condition: K084||Partial loss of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Implant placement with Injectable Platelet Rich Fibrin |
15 sites will be selected based on inclusion criteria and Injectable Platelet Rich Fibrin applied slowly over the implant surface taking care to make sure that it is evenly coated entire surface of the implant |
| Comparator Agent |
Implant Placement without Injectable Platelet Rich Fibrin |
15 sites will be selected based on inclusion criteria and implant is placed without Injectable Platelet Rich Fibrin |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
i)Systemically healthy patients(ASA I,II).
ii)Patients with Stable occlusion.
iii)Adequate bone height and width at the surgical site.
iv)Adequate mesiodistal and interocclusal spaces in the edentulous area. |
|
| ExclusionCriteria |
| Details |
â—¦Presence of active periodontal disease.
â—¦Pregnancy or Lactation women.
i)Patients with any systemic disease and medications that will interfere with treatment outcome.
ii)History of radiotherapy or chemotherapy.
iii)Primary stability less than 25 Ncm during fixture placement. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Implant stability measurement,
Radiographic evaluation |
Baseline,10 days,1 month, 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Radiographic evaluation |
3 months and 6 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
28/11/2024 |
| 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="8"
Days="8" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
A randomized single blinded clinical study will be conducted. A total number of 30 implants will be placed in edentulous spaces in both maxilla and mandible in systemically healthy patients. Patients will be selected based on inclusion criteria. Informed consent will be taken from the patients.Patients were examined clinically, and the residual bone will be evaluated using a CBCT. Blood examinations will be obtained to make sure the individuals were ideal candidates. Each 15 implants(NORIS,Int.HexTi.Tufted implant) will be randomly allocated to Test (with I-PRF) and Control (without I-PRF) groups.Implant stability will be measured in 2 groups immediately after implant placement (baseline),10 days,1 month, 3 months and 6 months and marginal bone levels will be measured at 3 and 6 months.All the parameters will be recorded by other operator to avoid Bias. |