| CTRI Number |
CTRI/2023/03/050409 [Registered on: 06/03/2023] Trial Registered Prospectively |
| Last Modified On: |
03/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluating the effect of ossseodensification technique of implant placement on bone around dental implants. |
|
Scientific Title of Study
|
Evaluating the effect of osseodensification technique versus conventional technique of implant placement on bone marker (BMP-9) and clinical implant parameters: A Randomized controlled trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Husbana Bakrolwala |
| Designation |
Junior Resident |
| Affiliation |
King Georges Medical University, Faculty of Dental Sciences, Lucknow Uttar Pradesh |
| Address |
New Dental Building, 6th floor, Department of Prosthodontica and Crowns and Bridges, FODS, King Georges Medical University, Lucknow, Uttar Pradesh 226003, India
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
8356098967 |
| Fax |
|
| Email |
husbakrolwala@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pooran Chand |
| Designation |
Professor and Head of the Department |
| Affiliation |
King Georges Medical University, Faculty of Dental Sciences, Lucknow Uttar Pradesh |
| Address |
New Dental Building, 6th floor, Department of Prosthodontica and Crowns and Bridges, FODS, King Georges Medical University, Lucknow, Uttar Pradesh 226003, India
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9415173419 |
| Fax |
|
| Email |
dr.pooran_chand@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Husbana Bakrolwala |
| Designation |
Junior Resident |
| Affiliation |
King Georges Medical University, Faculty of Dental Sciences, Lucknow Uttar Pradesh |
| Address |
New Dental Building, 6th floor, Department of Prosthodontica and Crowns and Bridges, FODS, King Georges Medical University, Lucknow, Uttar Pradesh 226003, India
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
8356098967 |
| Fax |
|
| Email |
husbakrolwala@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Prosthodontics and Crown and Bridge, FODS, King Georges Medical University, Lucknow. |
|
|
Primary Sponsor
|
| Name |
Husbana Bakrolwala |
| Address |
New Dental Building, 6th floor, Department of Prosthodontics and Crown and Bride, FODS, King Georges Medical University, Lucknow-226003 |
| Type of Sponsor |
Other [Self] |
|
|
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 Husbana Bakrolwala |
King George Medical University |
New dental building, 6th floor, Department of Prosthodontics and Crown and Bridges, FODS, King George Medical University. Shah Mina Road, Chowk, Lucknow- 226003
Lucknow
UTTAR PRADESH |
8356098967
husbakrolwala@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| King Georges Medical University U.P. Institutional Ethics Committee. Lucknow-226003 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K084||Partial loss of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional drilling group |
In this group, implant site preparation will be done using conventional drilling protocol and provisional crown placement within 48 hrs. |
| Intervention |
Osseodensification drilling group |
In this group, implant site preparation will be done using Osseodensification drilling protocol and provisional crown placement within 48 hrs. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Age group 18 and above and patient willing to participate in the study.
2. Patients with edentulous space in the maxillary jaw having healed bone site indicated for rehabilitation with implants.
3. Patient having sufficient residual bone volume for implant placement.
4. Patient having good general health with no systemic disease.
5. Patient having adequate oral hygiene. |
|
| ExclusionCriteria |
| Details |
1. Patients with para functional habits such as bruxism and clenching.
2. Patients with local limitations such as inadequate inter-ridge distance.
3. Patients who consume alcohol, smoke or use illicit drugs.
4. Patient with any systemic disease, irradiated patients, patients with previous or active treatments with steroids or bisphosphonates
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To analyse and compare levels of BMP-9 in peri-implant crevicular fluid (PICF) around implants placed using osseodensification (OD) drilling protocol and conventional drilling protocol. |
2 weeks, 8 weeks, 16 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare primary and secondary stability of implants placed using Osseodensification drilling protocol and Conventional drilling protocol. |
At the time of implant placement, 2 weeks, 8 weeks |
| To compare the crestal bone loss around implants placed using Osseodensification drilling protocol and Conventional drilling protocol. |
Baseline, 2 weeks, 8 weeks, 16 weeks, 6 months |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/03/2023 |
| Date of Study Completion (India) |
06/01/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
06/01/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Dental implants have revolutionised the field of oral rehabilitation with a success rate of 95% after 10 years of observational follow-ups1. However, in case of low bone density, such as upper human jaw, the insufficient bone around the implants could negatively influence the histomorphometric parameters (such as % BIC and % BV) and consequently their success rates.The relatively novel osteotomy preparation technique of osseodensification (OD) developed by Huwais in 2013, has prompted a paradigm shift in the implant site preparation techniques.2,3The conventional implant site preparation techniques are subtractive in nature, however osseodensification is non subtractive drilling technique using uniquely designed drills that rotate in a counterclockwise direction compacting bone at the osteotomy walls allowing more intimate engagement of the implant with the osteotomy site. OD technique has been based on the bone elastic and plastic properties which facilitate bone bulk preservation, resulting in the autografting of osseous material into the trabecular space and enhancing its density and also accelerating de novo bone formation at the implant site. Despite the fact that many studies conducted on animal models have demonstrated a favourable outcome of osseodensification over conventional drilling technique, it’s clinical effect in human studies during the osseous healing is not clear. Also, little is known about the molecular events and crestal bone loss when using this technique. Null hypothesis It will be hypothesized no difference on bone markerBMP-9, implant stability and crestal bone loss will be found whether osseodensification drilling protocol or conventional drilling protocol is used for implant placement. Objectives: Primary objective- To analyse and compare levels of BMP-9 in peri-implant crevicular fluid (PICF) around implants placed using osseodensification (OD) drilling protocol and conventional drilling protocol Secondary Objectives- 1. To compare primary and secondary stability of implants placed using osseodensification drilling protocol and conventional drilling protocol. 2. To compare the crestal bone loss around implants placed using osseodensification drilling protocol and conventional drilling protocol. 3. To determine if any association exists between the levels of BMP-9 with implant stability and crestal bone loss. |