| CTRI Number |
CTRI/2026/01/101271 [Registered on: 15/01/2026] Trial Registered Prospectively |
| Last Modified On: |
10/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Simple Comparison of Traditional Drilling and a New Bone-Saving Technique for Dental Implants |
|
Scientific Title of Study
|
Clinical Evaluation of Conventional versus Osseodensification Drilling in Implant Placement |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ayush Chettri |
| Designation |
Post Graduate student |
| Affiliation |
Himachal Institute of Dental Sciences, Poanta Sahib,Himachal Pradesh. |
| Address |
Himachal Institute of Dental Sciences
Department of Periodontics And Implantology
Room no 4
Paonta Sahib
Himachal Pradesh Paonta Sahib Sirmaur HIMACHAL PRADESH 173025 India |
| Phone |
07076797030 |
| Fax |
|
| Email |
ayushbhandari53@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Mukesh Kumar |
| Designation |
Professsor |
| Affiliation |
Himachal Institute of Dental Sciences, Poanta Sahib,Himachal Pradesh. |
| Address |
Himachal Institute of Dental Sciences
Department of Periodontics And Implantology
Room no 4
Paonta Sahib
Himachal Pradesh Paonta Sahib Sirmaur HIMACHAL PRADESH 173025 India |
| Phone |
09318903280 |
| Fax |
|
| Email |
drmks78@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Mukesh Kumar |
| Designation |
Professsor |
| Affiliation |
Himachal Institute of Dental Sciences, Poanta Sahib,Himachal Pradesh. |
| Address |
Himachal Institute of Dental Sciences
Department of Periodontics And Implantology
Room no 4
Paonta Sahib
Himachal Pradesh Paonta Sahib Sirmaur HIMACHAL PRADESH 173025 India |
| Phone |
09318903280 |
| Fax |
|
| Email |
drmks78@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Individual Ayush Chettri |
| Address |
Himachal Institute of Dental Sciences,
Paonta Sahib |
| Type of Sponsor |
Other [self sponsored] |
|
|
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 |
| Ayush Chettri |
Himachal Institute of Dental Sciences, Poanta Sahib,Himachal Pradesh. |
Himachal Institute of Dental Sciences
Department of Periodontics And Implantology
Room no 4
Paonta Sahib Sirmaur HIMACHAL PRADESH |
07076797030
ayushbhandari53@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| HIDS Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Edentulous area in oral cavity |
| Patients |
(1) ICD-10 Condition: K069||Disorder of gingiva and edentulousalveolar ridge, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Conventional implant drills |
Conventional implant drilling involves using standard drills in a clockwise direction to create osteotomy for implant placement. This method removes bone tissue in a subtractive manner, meaning the drills cut away bone material |
| Comparator Agent |
Osseodensification drills |
Osseodensification drills are designed to densify bone by rotating drills in a counterclockwise manner, creating a low plastic deformation of bone. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are willing to comply with all the study related procedures after signing an informed consent form.
Both males and females patients will be taken.
Non-contributing medical history.
Good oral hygiene.
Edentulous area requiring implant placement.
|
|
| ExclusionCriteria |
| Details |
Systemic diseases
Taking medication that effect bone formation.
Oral mucosal lesions.
History of radiation therapy.
Alcoholics, smokers.
Severe bruxism
Poor oral hygiene
Pregnancy |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| assess primary stability and potentially increase bone density around the implant site prepared using osseodensification drills |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| enhanced secondary stability and improved bone to implant contact |
1 year |
|
|
Target Sample Size
|
Total Sample Size="20" Sample Size from India="20"
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)
|
14/02/2026 |
| 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="0" 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
|
Clinical Evaluation of Conventional vs.
Osseodensification Drilling in Implant Placement’ aims to compare the
clinical outcomes of two implant drilling techniques—conventional drilling and
osseodensification. The study focuses on assessing which method provides better
implant stability and bone preservation during dental implant placement. Conventional
drilling removes bone to create the implant site, which can reduce bone density
and compromise implant stability, particularly in areas with low bone quality.
In contrast, osseodensification is a newer technique that uses specially
designed burs to preserve and compact the bone during osteotomy, potentially
improving both primary stability and long-term outcomes. The objectives of the
study are to compare soft tissue parameters such as implant probing depth,
healing index, plaque index, and bleeding index, as well as hard tissue
parameters like marginal bone levels, both clinically and radiographically. The
study will include adult patients who require dental implants and meet the
inclusion criteria of good general and oral health. Patients with conditions
affecting bone metabolism, smokers, pregnant women, and those with poor oral
hygiene or a history of radiation therapy will be excluded from the study. A
randomized clinical trial design will be used, with participants divided into
two groups—one receiving implants via conventional drilling and the other via
osseodensification. Clinical and radiographic evaluations will be post-operatively
using tools such as CBCT and RVG. |