| CTRI Number |
CTRI/2025/08/093152 [Registered on: 18/08/2025] Trial Registered Prospectively |
| Last Modified On: |
14/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing Implant Stability and Bone Health in Immediate vs Delayed Implants Using Two Drilling Methods in the Front Upper Jaw |
|
Scientific Title of Study
|
Comparative Evaluation of Implant Stability and Bone Assessment in Delayed and Immediate Implant Using Conventional and Osseodensification Drilling in Maxillary Esthetic Zone: Randomised Control 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 |
DrKomal Ware |
| Designation |
Post Graduate Student |
| Affiliation |
Government Dental College and Hospital Nagpur |
| Address |
Room No 202 Department of Periodontology Government Dental College and Hospital Nagpur
Hanuman Nagar Medical Chowk Nagpur Maharashtra 440003
Nagpur
MAHARASHTRA
440003
India |
| Phone |
8087857934 |
| Fax |
|
| Email |
komalware20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrMangesh Phadnaik |
| Designation |
PG Guide |
| Affiliation |
Government Dental College and Hospital Nagpur |
| Address |
Room No 202 Department of Periodontology Government Dental College and Hospital Nagpur
Nagpur
MAHARASHTRA
440003
India |
| Phone |
9422254404 |
| Fax |
|
| Email |
drmbphadnaik@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrKomal Ware |
| Designation |
Post Graduate Student |
| Affiliation |
Government Dental College and Hospital Nagpur |
| Address |
Room No 202 Department of Periodontology Government Dental College and Hospital Nagpur
Hanuman Nagar Medical Chowk Nagpur Maharashtra 440003
Nagpur
MAHARASHTRA
440003
India |
| Phone |
8087857934 |
| Fax |
|
| Email |
komalware20@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Dental College and Hospital,Nagpur,India , 440003 |
|
|
Primary Sponsor
|
| Name |
Dr Komal Ware |
| Address |
Government Dental College and Hospital ,Nagpur,India,440003 |
| Type of Sponsor |
Other [{Self funded}] |
|
|
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 |
| DrKomal Ware |
Government Dental College and Hospital,Nagpur |
Room No. 202,Department of Periodontology
Nagpur
MAHARASHTRA |
8087857934
komalware20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Dental college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K069||Disorder of gingiva and edentulousalveolar ridge, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Drilling in Delayed & Immediate implant placement |
After obtaining informed consent, participants will be seated comfortably in a dental chair under aseptic conditions. The surgical site in the maxillary esthetic zone will be anesthetized using local anesthesia. Based on random allocation, participants will be divided into four groups. Group 1 (Delayed implant with conventional drilling): Osteotomy will be performed using the conventional drilling sequence, followed by implant placement after adequate healing. Group 2 (Delayed implant with osseodensification): Osteotomy will be performed using osseodensification burs in a counter-clockwise motion, and implant placement will be done after healing.Conventional Drilling Technique:
In the conventional drilling technique, osteotomy is performed using a standard sequence of drills with progressively increasing diameters at high speed in a clockwise direction. The process involves cutting and removing bone to create space for implant placement. This technique may result in some loss of bone density around the osteotomy site due to removal of bone particles during drilling. It is widely used and follows the standard protocol provided by the implant manufacturer. Irrigation is used throughout the procedure to prevent heat generation and bone necrosis. |
| Intervention |
Osseodensification Drilling Technique in Delayed & Immediate Implant |
After obtaining informed consent, participants will be seated comfortably in a dental chair under aseptic conditions. The surgical site in the maxillary esthetic zone will be anesthetized using local anesthesia. Based on random allocation, participants will be divided into four groups.Group 3 (Immediate implant with conventional drilling): Extraction will be followed by osteotomy using the conventional drilling method and immediate implant placement. Group 4 (Immediate implant with osseodensification): Immediate implant placement will be done post-extraction using osseodensification drilling technique.Osseodensification Drilling Technique:
Osseodensification is a non-subtractive drilling technique performed using specially designed Densah burs in a counter-clockwise (reverse) rotation at controlled speed and torque. Instead of removing bone, this technique compacts and autografts bone along the osteotomy walls, leading to increased bone density and improved primary stability. It preserves bone structure and promotes faster healing by enhancing bone-to-implant contact. Saline irrigation is maintained throughout to avoid heat generation. This method is especially beneficial in areas with low bone density, such as the maxillary esthetic zone. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1)Systemically healthy patients requiring and opting Dental Implants in maxillary Esthetic Zone
2)Sites will be Maxillary Esthetic Zone
4)Good oral hygiene and periodontal status
5)Adequate amount of bone volume at implant site allowing to perform the surgery.
|
|
| ExclusionCriteria |
| Details |
1) Patients with systemic diseases that contraindicates the surgery, immune compromised patients.
2) Pregnant or lactating females.
3) H/o radiotherapy, smokers, parafunctional habits, acute and chronic infection.
4) Patients not willing to participate in the study or During the Study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Primary Implant Stability
2.secondary Implant Stability
3.Crestal bone level
4.Bone Density
|
Baseline,3rd Month,6th Month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Clinical soft tissue outcomes
BOP – Muhlemann’s Papillary Bleeding Index
PPD- by UNC – 15 probe
Patient satisfaction index
|
Baseline,3rd Month,6th Month |
|
|
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 3 |
|
Date of First Enrollment (India)
|
25/08/2025 |
| 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 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
|
After obtaining informed consent, participants will be seated comfortably in a dental chair under aseptic precautions. The surgical site in the maxillary esthetic zone will be anesthetized using a local anesthetic. Patients will be randomly allocated into four groups: Group 1 – delayed implant placement using the conventional drilling technique; Group 2 – delayed implant placement using the osseodensification drilling technique; Group 3 – immediate implant placement using the conventional drilling technique; and Group 4 – immediate implant placement using the osseodensification drilling technique. Osteotomy will be performed according to the assigned drilling protocol. Implants of the same system and dimensions will be placed as per the preoperative assessment. Primary implant stability will be measured at the time of placement using resonance frequency analysis (RFA), and bone changes will be assessed radiographically at baseline, 3 months, and 6 months postoperatively. All patients will receive standard postoperative care and oral hygiene instructions.This randomized controlled clinical trial aims to compare implant stability and bone changes between conventional drilling and osseodensification techniques in both delayed and immediate implant placements in the maxillary esthetic zone. A total of four groups will be studied: 1. Group 1: Delayed implant with conventional drilling 2. Group 2: Delayed implant with osseodensification 3. Group 3: Immediate implant with conventional drilling 4. Group 4: Immediate implant with osseodensification All implants will be placed under strict aseptic conditions using standardized surgical protocols. Implant stability will be measured using resonance frequency analysis (RFA) at placement and during follow-up. Radiographic bone level assessment will be performed at baseline, 3 months, and 6 months postoperatively. The study will help evaluate the effectiveness of osseodensification in enhancing implant stability and preserving peri-implant bone in esthetic areas.
|