| CTRI Number |
CTRI/2024/11/076283 [Registered on: 05/11/2024] Trial Registered Prospectively |
| Last Modified On: |
30/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
To evaluate and compare the implant primary stability between Ridge Split technique and Osseodensification technique. |
|
Scientific Title of Study
|
Comparative evaluation of primary stability of dental implants in Conventional Ridge Split technique and Osseodensification in narrow mandibular ridge. |
| 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 Meghna Agarwal |
| Designation |
2nd yr post graduate |
| Affiliation |
ACPM DENTAL COLLEGE, DHULE |
| Address |
Department of Prosthodontics, Crown and Bridge and Implantology , floor 1 , department no 7, Acpm dental college, Dhule
Dhule
MAHARASHTRA
424001
India |
| Phone |
08291999387 |
| Fax |
|
| Email |
drmeghnaagarwal26@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Girija Dodamani |
| Designation |
Professor of Department of Prosthodontics Crown and Bridge |
| Affiliation |
ACPM DENTAL COLLEGE, DHULE |
| Address |
Department of Prosthodontics, Crown and Bridge and Implantology , floor 1 , department no 7, Acpm dental college, Dhule
MAHARASHTRA
424001
India |
| Phone |
7020966944 |
| Fax |
|
| Email |
girijadodamani9999@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Meghna Agarwal |
| Designation |
2nd yr post graduate |
| Affiliation |
ACPM DENTAL COLLEGE, DHULE |
| Address |
Department of Prosthodontics, Crown and Bridge and Implantology , floor 1 , department no 7, Acpm dental college, Dhule
MAHARASHTRA
424001
India |
| Phone |
08291999387 |
| Fax |
|
| Email |
drmeghnaagarwal26@gmail.com |
|
|
Source of Monetary or Material Support
|
| ACPM Dental College, Sakri road, Dhule , Maharashtra
Pincode- 424001 |
|
|
Primary Sponsor
|
| Name |
DR MEGHNA AGARWAL |
| Address |
Department of Prosthodontics, Crown and Bridge and Implantology , floor 1 , department no 7, ACPM dental college, Dhule, Maharashtra
Pincode- 424001 |
| 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 Meghna Agarwal |
Acpm Dental College |
Department of Prosthodontics, Crown and Bridge and Implantology , floor 1 , Department no 7
Dhule
MAHARASHTRA |
08291999387
drmeghnaagarwal26@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE JMF ACPM DENTAL COLLEGE, DHULE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Densah® Bur VT1525 2.0-mm (Versah) |
Group II: Comprising 7 implant sites, this group will undergo the osseodensification technique, followed by the subsequent placement of 2 implants each. The duration is one month. |
| Comparator Agent |
ridgesplit surgery unit (Dentium) |
Group I: This consisted of 7 implant sites that will undergo the ridgesplit technique, followed by the placement of 2 implants each. The duration is one month. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1 Dental Condition: The presence of good oral hygiene.
2 Patients with extended posterior edentulous mandibular areas, encompassing a minimum of two missing teeth ie 36/37 or 46/47
3 Patients willing to actively participate in the study.
4 Minimum bone height of 12mm measured from the crest of the ridge to the upper border of the inferior alveolar canal.
5 Minimum ridge thickness of 3mm, with measurements less than 5mm at the crestal region.
6 Implant sites in consideration included both compact bone and cancellous bone.
|
|
| ExclusionCriteria |
| Details |
1. Uncontrolled systemic conditions.
2. Systemic disorders that could compromise osseointegration.
3. Use of medications, such as steroids, that could impact bone metabolism.
4 Smokers was excluded from the study.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome used in sample size calculation reveal a moderate yet statistically significant difference favoring Group II primary stability. This signifies that the osseodensification technique would led to superior outcomes compared to the ridge splitting technique. |
The outcome will be assessed/ estimated immediately after implant placement and prosthesis will be given after 3 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The compelling evidence from this study would strongly support the superiority of the osseodensification technique. This preference is attributed to the techniques capacity to enhance bone density, thereby contributing to an overall improvement in implant primary stability. |
The outcome will be assessed/estimated immediately after implant placement & prosthesis will be given after 3 months. |
|
|
Target Sample Size
|
Total Sample Size="14"
Sample Size from India="14"
Final Enrollment numbers achieved (Total)= "14"
Final Enrollment numbers achieved (India)="14" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/12/2024 |
| Date of Study Completion (India) |
28/12/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
28/12/2024 |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
AIM: The aim of the study was to evaluate and compare the primary stability of implants in Osseo densification and conventional ridge split technique in narrow mandibular ridge Materials and Methods: The study involved the division of 28 implants into two distinct groups. Group I comprised 14 implants subjected to the RIDGESPLIT technique, while Group II included 14 implants treated with the osseodensification technique. Subsequently, a comprehensive evaluation was conducted. Clinical evaluation of primary stability after implant insertion was performed using the Osstell Mentor magnetic resonance device. Results: An unpaired t-test was employed to compare the two groups, revealing a moderate statistically significant difference in Group II when compared with Group I in primary stability. Conclusion: Primary stability is affected by the osteotomy technique. Dental implants installed after osseodensification presented higher levels of insertion torque than ridgesplit technique. The results strongly favor the osseodensification technique, suggesting that it enhances bone density, thereby contributing to improved implant primary stability.
|