| CTRI Number |
CTRI/2020/08/026976 [Registered on: 04/08/2020] Trial Registered Prospectively |
| Last Modified On: |
24/07/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of different bone graft materials around dental implants in fresh extraction sockets |
|
Scientific Title of Study
|
Effect of Simvastatin-Platelet Rich Fibrin (PRF) Combination Vs PRF and Allograft Combination Vs PRF Alone as Peri-Implant Gap Filling Graft Materials around Immediate Implants on Vertical Bone Implant Contact and Implant Stability: A Pilot Randomized Clinical Study |
| Trial Acronym |
PRF |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gunjan Pruthi |
| Designation |
Assistant Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Division of Prosthodontics, OHSC, Sector 12, PGIMER Sector 12, Chandigarh Chandigarh CHANDIGARH 160012 India |
| Phone |
9999968841 |
| Fax |
|
| Email |
gunjan_prostho@yahoo.co.in |
|
Details of Contact Person Scientific Query
|
| Name |
Gunjan Pruthi |
| Designation |
Assistant Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Division of Prosthodontics, OHSC, Sector 12, PGIMER Sector 12, Chandigarh Chandigarh CHANDIGARH 160012 India |
| Phone |
9999968841 |
| Fax |
|
| Email |
gunjan_prostho@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Gunjan Pruthi |
| Designation |
Assistant Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Division of Prosthodontics, OHSC, Sector 12, PGIMER Sector 12, Chandigarh Chandigarh CHANDIGARH 160012 India |
| Phone |
9999968841 |
| Fax |
|
| Email |
gunjan_prostho@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ICMR |
| Address |
V. Ramalingaswami Bhawan, P.O. Box No. 4911
Ansari Nagar, New Delhi - 110029, India |
| Type of Sponsor |
Government funding agency |
|
|
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 |
| Gunjan Pruthi |
OHSC, PGIMER |
Sector 12 Chandigarh CHANDIGARH |
9999968841
gunjan_prostho@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Post graduate Institute of Medical Education and Research, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients with upper anterior teeth indicated for extraction |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Alloplast bone graft material |
Alloplast bone graft material will be placed in periimplant gap after placement of implant |
| Intervention |
L-PRF |
L-pRF membrane will be placed in periimplant gap around implant |
| Intervention |
Simvastatin gel in perimplant gap |
Simvastatin gel will be prepared and placed in peri implant gap after placement of dental implant. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with good systemic general and periodontal health, irrespective of sex and having age between 18-45 years
2. Patients in need of anterior single tooth extraction (maxillary incisors, canines, or premolars) because of any indication like failed endodontics, poor prognosis of repeat RCT, trauma, mobility, root fracture etc
3. Perimplant gap ≥ 2mm
4. Willing for participation in study, giving written informed consent and follow up
|
|
| ExclusionCriteria |
| Details |
1. Patients with parafunctional habits, history of smoking, diabetes, any other systemic health problem, immuno compromised state, or pregnant females.
2. Symptomatic periapical lesions, acute abscesses, or sinus tracts in relation to tooth in question or adjacent teeth
3. Secondary exclusion criterion kept will be peri implant gap of more than 5mm
4. Primary stability of less than 35 N/cm.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Vertical bone to implant contact (BIC) on labial side of implant on cone beam CT and on mesial and distal sides on IOPA |
Vertical bone to implant contact (BIC) on labial side of implant on cone beam CT and on mesial and distal sides on IOPA immediately after surgery, 6 months after surgery and one year. CBCT immediately and one year after surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcome variable (SOV): Implant stability (Implant stability quotient values measured on Radio frequency analyser) |
SOV will be measured at baseline, at 3 months and at one year. |
|
|
Target Sample Size
|
Total Sample Size="36" Sample Size from India="36"
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 1 |
|
Date of First Enrollment (India)
|
01/09/2020 |
| 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="3" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet related to this subject. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Dental implants are placed in oral cavity to replace
missing teeth. If they are placed in fresh extraction sockets, they are called
as “Immediate implantsâ€. To promote the bone formation around implants and to
hasten healing, we need to put some graft material in the gap present between
the socket walls and the implant. These graft materials can be artificial bone
derived from different sources or platelet rich fibrin derived from patient’s
own blood. Recently Simvastatin (medicine used for patients with heart related
problems) has been used in animals and humans to promote bone formation. In
this study, it will be prepared in form of gel in department of Pharmacology
and its effect will be assessed on bone formation around implants and if there
is any improvement in stability of implants in one year time period. For that,
36 patients with poor prognosis of upper front teeth will be enrolled. Tooth
will be extracted followed by implant placement and grafting with one of the
graft materials. Artificial crown will be fabricated over implant after 3
months and patients will be kept on follow up till one year after implant
placement. Bone formation will be measured on radiographs two times (just after
implant placement and at one year) and stability of implants will be measured
three times ((just after implant placement, at 3 months and at one year). If we
find good results, Simvastatin can be used in multiple clinical scenarios to
promote bone formation. |