| CTRI Number |
CTRI/2024/10/074888 [Registered on: 08/10/2024] Trial Registered Prospectively |
| Last Modified On: |
03/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Increasing the size of upper front region of jaw with help of two different procedures (osseodensification and threaded expander technique)for missing teeth replacement using implant |
|
Scientific Title of Study
|
Comparative evaluation of Ridge expansion in maxillary esthetic zone using threaded expander technique and Osseodensification technique for simultaneous implant placement A Randomized Controlled 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 |
Dr Deepak Prakash Gawande |
| Designation |
Post Graduate Student |
| Affiliation |
Government Dental College And Hospital |
| Address |
Department of Periodontology , 2nd Floor , Government Dental College and Hospital , GMC Campus Wanjari Nagar , Nagpur
440003
Nagpur
MAHARASHTRA
440003
India |
| Phone |
8806351084 |
| Fax |
|
| Email |
143deepoo@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vivek Thombre |
| Designation |
Associate Professor Department of Periodontology |
| Affiliation |
Government Dental College And Hospital |
| Address |
Department Of Periodontology , 2nd floor , room no 212 , Government Dental College And Hospital Wanajari Nagar GMC Campus Nagpur 440003
Nagpur
MAHARASHTRA
440003
India |
| Phone |
8806351084 |
| Fax |
|
| Email |
drvivekthombre@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepak Prakash Gawande |
| Designation |
Post Graduate Student |
| Affiliation |
Government Dental College And Hospital |
| Address |
Department Of Periodontology , 2nd floor , Room no 212 , Government Dental College And Hospital Wanajari Nagar GMC Campus Nagpur 440003
Nagpur
MAHARASHTRA
440003
India |
| Phone |
8806351084 |
| Fax |
|
| Email |
143deepoo@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Periodontology , 2nd Floor , Government Dental College and Hospital , GMC Campus , Wanjari Nagar , Nagpur 440003 |
|
|
Primary Sponsor
|
| Name |
Dr Deepak Prakash Gawande |
| Address |
Department of Periodontology , 2nd Floor , Government Dental College and Hospital , GMC Campus , Wanjari Nagar , Nagpur 440003 |
| 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 Deepak Prakash Gawande |
Government Dental College And Hospital Nagpur |
Department of Periodontology , 2nd Floor , Room no 202 , Government Dental College and Hospital , GMC Campus , Wanjari Nagar , Nagpur
Nagpur
MAHARASHTRA |
8788982188
143deepoo@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Dental College and Hospital Nagpur Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K063||Horizontal alveolar bone loss, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Expansion of Edentulous Ridge in Maxillary Esthetic Region using Osseodensification Technique |
To Evaluate Change in Bone Width, Bone Density, Crestal Bone Level and Primary Stability of Implant, after Ridge Expansion and Simultaneous Implant Placement using Osseodensification Technique (Using Densah Burs) |
| Intervention |
Expansion Of Edentulous Ridge in Maxillary Esthetic Region Using Threaded Expander Technique |
To Evaluate Change in Bone Width, Bone Density, Crestal Bone Level and Primary Stability of Implant, after Ridge Expansion and Simultaneous Implant Placement using Threaded Expander Technique (Using Screw Expanders to Expand the Osteotomy Site)
|
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Systemically healthy subjects requiring and opting Dental Implants for replacement of missing teeth in maxillary anterior esthetic region
2. Inadequate Bucco-palatal width in the edentulous area ≤5mm
3. Adequate oral hygiene
4. Maxillary esthetic region
|
|
| ExclusionCriteria |
| Details |
1. Subjects with systemic diseases that contraindicates the surgery, immune compromised subjects
2. Past or present treatment with intravenous amino-bisphosphonates.
3. Any residual infectious lesion associated with edentulous area , inflammation , Smokers , subjects undergoing radiation therapy
4. Pregnancy
5. Severe bruxism
6. Clenching habit
7. Subjects not willing to participate in the study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment of Bone width
placed by two techniques: threaded expander technique and Osseodensification technique |
at baseline and at 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Bone density
2. Crestal bone level
3. Primary stability of implant
around the Implants placed by two techniques: threaded expander technique and Osseodensification technique |
at baseline and at 6 months |
|
|
Target Sample Size
|
Total Sample Size="16"
Sample Size from India="16"
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)
|
15/10/2024 |
| 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 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [143deepoo@gmail.com].
- For how long will this data be available start date provided 15-10-2026 and end date provided 15-10-2099?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Dental
implants have become a popular alternative in the oral and maxillofacial rehabilitation after the
introduction of the concept of osseointegration.Successful
dental implant placement requires sufficient bone to be available in three
dimensions so that sufficient primary stability is achieved.Conventionally
this difficulty was resolved by the use of bone grafts, membranes, titanium
meshes, and screws that increase the cost, even with the use of autogenous bone
and blood derivatives.A
novel osseodensification approach was introduced in 2016 by Huwais and Meyer .Osseodensification uses densifying Burs to produce low plastic deformation
owing to its non-removal method of site preparation, which preserves the bone
enhancing the host site. These special burs demonstrated the ability to expand
narrow bone ridges 2nd technique , to improve the quality and quantity of bone around the implant, using threaded expanders that can facilitate width expansion of atrophic
alveolar ridges without using |