| CTRI Number |
CTRI/2025/03/082910 [Registered on: 20/03/2025] Trial Registered Prospectively |
| Last Modified On: |
17/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to evaluate the efficacy of A-PRF on crestal bone level around immediate dental implant |
|
Scientific Title of Study
|
A randomized controlled clinical trial to evaluate the efficacy of A-PRF on crestal bone level around Immediate Dental Implant |
| 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 Mohit Bansal |
| Designation |
post graduate |
| Affiliation |
Uttar Pradesh University of Medical Sciences |
| Address |
room no-423, Department of Periodontology, Uttar Pradesh University of Medical Sciences, Saifai, Etawah
Uttar Pradesh University of Medical Sciences, Saifai, Etawah, Uttar Pradesh
Etawah
UTTAR PRADESH
206130
India |
| Phone |
8076259412 |
| Fax |
|
| Email |
bansalmohit877@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bipin Kumar Yadav |
| Designation |
Professor |
| Affiliation |
Uttar Pradesh University of Medical Sciences |
| Address |
Department of Periodontology, Faculty of dental sciences, Uttar Pradesh University of Medical Sciences, Saifai, Etawah, Uttar Pradesh
Uttar Pradesh University of Medical Sciences, Saifai, Etawah, Uttar Pradesh
Etawah
UTTAR PRADESH
206130
India |
| Phone |
8449619482 |
| Fax |
|
| Email |
drbipinyadav@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohit Bansal |
| Designation |
post graduate |
| Affiliation |
Uttar Pradesh University of Medical Sciences |
| Address |
Department of Periodontology, Faculty of Dental Sciences,Uttar Pradesh University of Medical Sciences, Saifai, Etawah, Uttar Pradesh
Uttar Pradesh University of Medical Sciences, Saifai, Etawah, Uttar Pradesh
Etawah
UTTAR PRADESH
206130
India |
| Phone |
8076259412 |
| Fax |
|
| Email |
bansalmohit877@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Periodontology, Faculty of dental sciences, Uttar Pradesh University of dental sciences, Saifai, Etawah, Uttar Pradesh, India. pincode - 206130 |
|
|
Primary Sponsor
|
| Name |
Dr Mohit Bansal |
| Address |
A-303, Swami Vivekananda hostel, new campus
Uttar Pradesh University of Medical Sciences, Saifai, Etawah -206130 |
| 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 Mohit Bansal |
Uttar Pradesh University of Medical Sciences |
room no - 423, Department of Periodontology, Faculty of dental sciences, Uttar Pradesh University of Medical Sciences, Saifai, Etawah, Uttar Pradesh
Etawah
UTTAR PRADESH |
08800421053
bansalmohit877@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee, Uttar Pradesh University of dental sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
advanced platelet rich fibrin |
advanced platelet-rich fibrin along with bone graft placed in a gap present between implant and bone |
| Comparator Agent |
bone graft |
bone graft placed ina gap present between implant and bone |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Teeth that require extraction due to fracture of root, residual roots, internal and
external resorption, endodontic failures, non-restorable carious lesions, over-retained deciduous teeth, Sufficient alveolar bone at the site, systematically healthy patient, No acute infection
|
|
| ExclusionCriteria |
| Details |
Medically compromised patients, Poor bone quality or volume, Para functional habits, Habit of smoking, alcohol intake or drug abuse, Pregnant woman and lactating mother, non-compliance patient |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| peri-implant probing depth and IOPAR radiograph |
Peri-implant probing depth will be assessed at the time of implant loading and after 3 months of implant loading.
IOPAR will be taken to assess the crestal bone level (from platform of implant till bone level) at baseline, at 3 months, at time of implant loading (After 4-6 months of implant placement), and at 3 months after implant loading. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| plaque index (PI) and gingival index (GI) |
PI and GI will be assessed before implant placement and after 3 months of implant loading. |
|
|
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 3 |
|
Date of First Enrollment (India)
|
05/05/2025 |
| 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="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
·
Background: Dental implant is a newer treatment modality
to replace the missing tooth. The conventional protocol for dental implant placement
suggested 3 to 6 month
waiting period for healing following tooth extraction. In immediate dental implant placement, implant is
directly placed at time of extraction which eliminate
the waiting period for socket healing. Immediate dental implants have revolutionized implant dentistry by drastically shortening the treatment
time. After tooth extraction,
the crestal bone loss occurs which continue even after placing the immediate implant. To prevent or reduce crestal bone
loss various bone grafts and membrane are used. In the present study, A- PRF
will be mixed with bone graft as an autologous biomaterial to promote
bone healing.
·
Novelty: A-PRF
mixed with bone graft will be placed
between immediate implant and socket wall which facilitate bone formation. More number of leucocytes and platelets are present
in A-PRF which is prepared by decreasing RPM (rotation per
minutes) and increasing the centrifugation time. A-PRF releases growth
factors in a slow and continuous manner for longer duration.
·
Objectives: To find out the effect of A-PRF on crestal bone level around immediate implant
clinically and radiographically.
· Methods:
The present study is a randomized controlled clinical trial.
Patients will be selected as per
inclusion criteria and randomly divided into two groups on the basis of
placement of A-PRF. In Group I, immediate implant placement with bone graft around
the implant whereas in Group II, immediate
implant placement with A-PRF and bone graft around the implant will be done. The
clinical parameters which include PI
and GI will be assessed before implant placement and at after 3 months of implant loading. PPD will be
assessed at the time of implant loading and at after 3 months
of implant loading and radiological parameter include crestal bone level will be assessed by
using IOPAR / CBCT will be recorded at baseline, 3 months, at time
of implant loading and 3 months after implant loading.
Expected
outcomes: This study expects to find out the additional effect
of A- PRF with bone graft around the
immediate implant results in less crestal bone loss as compared to sites where A-PRF is not placed along with immediate implants.· |