| CTRI Number |
CTRI/2023/11/059974 [Registered on: 17/11/2023] Trial Registered Prospectively |
| Last Modified On: |
16/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Compairing Stability of dental implants placed in jaw bone using two different methods |
|
Scientific Title of Study
|
Comparative Evaluation Of Primary And Secondary Stability Of Implants Placed Through Osseodensification Versus Standard Drilling Technique - A Randomized Controlled 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 |
SHRADDHA SHILPI |
| Designation |
Academic Junior Resident |
| Affiliation |
Faculty Of Dental Sciences, Institute Of Medical Sciences, Banaras Hindu University |
| Address |
Unit Of Periodontology, Faculty Of Dental Sciences, IMS, BHU, Varanasi-221005, UP
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7488782582 |
| Fax |
|
| Email |
shraddhashilpi5436@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
MONIKA BANSAL |
| Designation |
Professor |
| Affiliation |
Faculty Of Dental Sciences, Institute of Medical Sciences, Banaras Hindu University |
| Address |
Unit Of Periodontology, Faculty Of Dental Sciences, IMS, BHU, Varanasi-221005, UP
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9335499117 |
| Fax |
|
| Email |
drmonika97@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SHRADDHA SHILPI |
| Designation |
Academic Junior Resident |
| Affiliation |
Faculty Of Dental Sciences, Institute Of Medical Sciences, Banaras Hindu University |
| Address |
Unit Of Periodontology, Faculty Of Dental Sciences, IMS, BHU, Varanasi-221005, UP
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7488782582 |
| Fax |
|
| Email |
shraddhashilpi5436@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Eminence, BHU and Unit of Periodontology, Faculty of Dental Sciences, IMS, BHU, Varanasi |
|
|
Primary Sponsor
|
| Name |
Shraddha Shilpi |
| Address |
Unit Of Periodontology, Faculty Of Dental Sciences, IMS, BHU, Varanasi-221005, UP |
| Type of Sponsor |
Other [Self Sponsoring] |
|
|
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 Shraddha Shilpi |
Faculty Of Dental Sciences IMS BHU |
Room no.5, Unit Of Periodontology, Faculty Of Dental Sciences, IMS, BHU, Varanasi-221005, Varanasi, UP
Varanasi
UTTAR PRADESH |
7488782582
shraddhashilpi5436@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Banaras Hindu University, IMS, Varanasi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
single/multiple edentulous sites (anterior/posterior maxilla or posterior mandible) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Implants placed through Osseodensification Technique. |
Implant will be placed through Osseodensification Technique using Densah Drills in edentulous sites in antetior or posterior maxilla and posterior mandible. Primary Implant Stability will be measured immediate post implant placement. Secondary Implant Stability will be measured 4 months after Implant Placement. Bone Density, Crestal Bone Level and Ridge Width will also be measured as per decided Time Frame. |
| Comparator Agent |
Implants placed through Standard Drilling Technique. |
Implant will be placed through Standard Drilling Technique using Conventional Drills in edentulous sites in anterior or posterior maxilla and posterior mandible. Primary Implant Stability will be measured immediate post implant placement. Secondary Implant Stability will be measured 4 months after Implant Placement. Bone Density, Crestal Bone Level and Ridge Width will also be measured as per decided Time Frame. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Physically, Mentally, and Systemically healthy patient.
2.Single / multiple missing teeth (anterior/posterior maxilla or posterior mandible). 3.Subjects with good plaque control, showing good compliance, willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
1. Subjects with systemic illness, osteoporosis, bleeding disorders etc.
2. Insufficient density or height of residual ridge.
3. Pregnant and Lactating females.
4. Subjects with history of smoking or smokeless tobacco.
5. drug or alcohol abuse.
6. Occlusal interferences.
7. Subjects with history of allergy.
8. Immunocompromised state and debilitating disease.
9. Radiotherapy/ Chemotherapy for malignancy. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Primary Implant Stability
2. Secondary Implant Stability |
1. Time Point for Primary Implant Stability is- Immediate Post Implant Placement
2. Time Point for Secondary Implant Stability is- 4 months after Implant Placement |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Bone Density
2.Crestal Bone Level
3.Ridge Width
4.IL-1beta & TNF-alpha(if feasible) |
1. Time Points for Bone Density are- Pre-Operative, Immediate post Implant Placement and after 6 months
2. Time Points for Crestal Bone Level are- Immediate post Implant Placement and after 6 months
3. Time Points for Ridge Width are- Pre-Operative and Immediate post Implant Placement
4. Time Points for IL-1beta & TNF-alpha are before prosthesis & 2 weeks after prosthesis(if feasible) |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
25/11/2023 |
| 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="2"
Days="0" |
|
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
|
Standard Drilling Technique results in excavation of bone to create room for implant fixation, that results in reduced Insertion Torque Value and Implant Stability Quotient leading to poor primary stability and potential decrease in osseointegration. In contrast, Osseodensification doesn’t excavate bone tissue, instead it compacts and autografts bone tissue in outward expanding direction in the osteotomy wall along the entire depth of the hole. Ergo, it increases bone density surrounding the preparation of implant site resulting in good implant stability. Use of specialized Densah Drills for Osseodensification in non-cutting direction with continuous slow irrigation produces controlled plastic deformation in bone resulting in its expansion in areas of narrow ridges. |