| CTRI Number |
CTRI/2025/03/082513 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
13/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Improving Bone Density with Osseodensification After Delayed dental implant placement: A clinical study after delayed implant placement: A clinical and radiographic study |
|
Scientific Title of Study
|
Evaluation of effectiveness of osseodensification system for improvement in bone density after delayed implant placement: A clinical and radiographic 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 |
Dr Rutuja Karamore |
| Designation |
Post graduate student |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Room number-003,Department of Periodontics,Sharad Pawar Dental College, Sawangi Meghe.
Wardha
MAHARASHTRA
442001
India |
| Phone |
09422282446 |
| Fax |
|
| Email |
rutujakaramore125@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prasad Dhadse |
| Designation |
Professor and Head |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Room number-003,Department of Periodontics,Sharad Pawar Dental College, Sawangi Meghe.
Wardha
MAHARASHTRA
442001
India |
| Phone |
9822689401 |
| Fax |
|
| Email |
drprasaddhadse@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prasad Dhadse |
| Designation |
Professor and Head |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Room number-003,Department of Periodontics,Sharad Pawar Dental College, Sawangi Meghe.
Wardha
MAHARASHTRA
442001
India |
| Phone |
9822689401 |
| Fax |
|
| Email |
drprasaddhadse@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research, Sawangi Meghe Wardha, India 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi Meghe Wardha, India 442001 |
| Type of Sponsor |
Private medical college |
|
|
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 Rutuja Karamore |
Sharad Pawar Dental College |
Room number-003, Department of Periodontics and Implantology, Sharad Pawar Dental College, Sawangi,Wardha
Wardha
MAHARASHTRA |
09422282446
rutujakaramore125@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K082||Atrophy of edentulous alveolar ridge, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Endosteal Implant |
Using osseodensification burs, endosteal implants will be placed in edentuloue maxilla and mandible in patients patient will be evaluated for the duration of baseline, 3 months, 6 months |
| Comparator Agent |
NIL |
NA |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Thick gingival biotype.
2.Radiographic and clinical appearance of intact alveolar bony walls.
3.4 mm of bone radiographically at root apex
4.D-2 or D-3 bone quality.
|
|
| ExclusionCriteria |
| Details |
1.Uncontrolled systemic conditions (e.g., diabetes, cardiovascular diseases).
2.Severe periodontal disease or active infections.
3.Insufficient bone requiring advanced grafting.
4.Pregnant or breastfeeding women.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| primary stability include enhanced mechanical retention of the implant due to increased bone density around the implant site. |
CBCT will be taken pre operatively, 3months and after 6 months of implant placement and bone density in Hounsfield unit will be checked. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NA |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/04/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This research study aims at assessing the efficiency of the
Osseodensification (OD) system in enhancing the bone density and volume in
cases with delayed implant placement. It assesses the OD impact on the healing
of bones and osseointegration, which is by comparing the clinical and
radiographic outcomes before surgery and after it.This is a six-month single-arm
clinical and radiographic study in 10 systemically healthy patients with
edentulous regions in the anterior or posterior arch. Pre-operative full-mouth
ultrasonic scaling, dental hygiene instructions, and pre-operative CBCT imaging
will be obtained to measure the bone density at the apical, mesial, and distal
regions of the extraction socket in Hounsfield units. Following local
anesthesia and implant surgery, osseodensification will be applied to increase
the density of the bone at the time of preparation of the implant site.
Postoperative care will include antibiotics, anti-inflammatory drugs, and
follow-up visits. Cone Beam Computed Tomography (CBCT) imaging will be done at
baseline, 3 months, and 6 months post-surgery to monitor changes in bone
density. Implant mobility will be measured using the Clinical Implant Mobility
Scale (CIMS). |