| CTRI Number |
CTRI/2019/03/017904 [Registered on: 01/03/2019] Trial Registered Prospectively |
| Last Modified On: |
29/03/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
The success of Dental implant treatment in dentistry is dependent on mainly two factors that is, firmness of dental implant with jaw bone and bone loss around dental implant.In this study evaluation is done for above factors. |
|
Scientific Title of Study
|
“Clinical evaluation of effect of placement of abutment–implant complex/microgap,machined collar on implant stability and marginal bone level changes of unloaded 2-piece implantsâ€- Clinical study. |
| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Deepak Macchindra Vikhe |
| Designation |
Associate Professor |
| Affiliation |
Rural Dental College. |
| Address |
Department of Prosthodontics,Rural Dental College,Loni-BK,Rahata,Ahmednagar,Pravara Institute Of Medical Sciences(Deemed University),Loni BK,Tal:Rahata,Dist:Ahmednagar,Maharashtra,413736
Ahmadnagar MAHARASHTRA 413736 India |
| Phone |
919822811117 |
| Fax |
912422273413 |
| Email |
drdeepak_mvikhe@yahoo.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Seemit Shah |
| Designation |
HOD and Professor |
| Affiliation |
Pravara institute of medical sciences. |
| Address |
Department of Oral Surgery,Rural Dental College,Loni-BK,Rahata,Ahmednagar,Pravara Institute Of Medical Sciences(Deemed University),Loni BK,Tal:Rahata,Dist:Ahmednagar,Maharashtra,413736
Ahmadnagar MAHARASHTRA 413736 India |
| Phone |
9823129828 |
| Fax |
912422273413 |
| Email |
nirav_seemit@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Deepak Macchindra Vikhe |
| Designation |
Associate Professor |
| Affiliation |
Pravara institute of medical sciences. |
| Address |
Department of Prosthodontics,Rural Dental College,Loni-BK,Rahata,Ahmednagar,Pravara Institute Of Medical Sciences(Deemed University),Loni BK,Tal:Rahata,Dist:Ahmednagar,Maharashtra,413736
Ahmadnagar MAHARASHTRA 413736 India |
| Phone |
919822811117 |
| Fax |
912422273413 |
| Email |
drdeepak_mvikhe@yahoo.com |
|
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Source of Monetary or Material Support
|
|
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Primary Sponsor
|
| Name |
Pravara Institute of Medical Sciences |
| Address |
Department of Prosthodontics,Rural Dental College,Loni-BK,Rahata,Ahmednagar,Pravara Institute Of Medical Sciences(Deemed University),Loni BK,Tal:Rahata,Dist:Ahmednagar,Maharashtra,413736 |
| Type of Sponsor |
Private medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Deepak Vikhe |
Rural Dental College. |
Department of Prosthodontics,Rural Dental College,Loni-BK,Rahata,Ahmednagar,Pravara Institute Of Medical Sciences(Deemed University),Loni BK,Tal:Rahata,Dist:Ahmednagar,Maharashtra,413736 Ahmadnagar MAHARASHTRA |
919822811117 912422273413 drdeepak_mvikhe@yahoo.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee,Pravara Institute of Medical Sciences(Deemed University) |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Adults with adequate bone support for implant placement with few teeth missing.
|
|
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Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects with adequate bone support for implant placement.
2. Implants placed in mandibular posterior region |
|
| ExclusionCriteria |
| Details |
1. Subjects with no systemic diseases. |
|
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Method of Generating Random Sequence
|
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Method of Concealment
|
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Blinding/Masking
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Primary Outcome
|
| Outcome |
TimePoints |
There will be less bone loss around Dental Implant with better treatment.
|
3,6 Months
|
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Healing around dental implant will be better.Less complications and less failure of dental implant after Laoading. |
6 Months |
|
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Target Sample Size
|
Total Sample Size="20" Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "26"
Final Enrollment numbers achieved (India)="28" |
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Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
07/03/2019 |
| Date of Study Completion (India) |
26/02/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2" Months="11" Days="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
20 dentate subjects with one or two missing teeth will be selected. The study procedure will be explained to the subjects and with prior consent of the subjects the study will be further conducted.All necessary investigations before implant placement will be carried out. 7 implants will be placed with abutment implant complex/microgap,machined collar supracrestally and other 7 implants will be placed with abutment implant complex/microgap,machined collar subracrestally by following proper manufacturer’s instructions. Implant stability will be measured by periotest instrument immediately after implant placement and 6 months after implant placement with implant mount in place in both technniqe. The readings will be correlated with a grading scale provided by manufactures of periotest instrument. This study was also undertaken to evaluate marginal bone loss on the mesial and distal side of the implant, by Digital opg in both technique at the end of six months after placing the implants, but before prosthetically loading it. A Digital opg and an IOPA X-ray was taken on the day of implant placement, one hour after the surgery. Crestal bone loss was measured on opg taken on the same machine, which was used for opg at the time of implant placement. The distance between the top of the implant and the level of crestal bone (first bone to implant contact) along the implant surface on mesial and distal side was measured on the opg machine monitor, using its software. The measured value was auto-corrected by the in-built software for radiographic magnification factor. All readings will be filled in the proforma for the study as given below and results will be analyzed. Keeping this in mind, a study will be undertaken to evaluation of effect of placement of abutment–implant complex/microgap,machined collar on implant stability and marginal bone level changes of unloaded 2-piece implants six months after the implant placement. The site was kept common in lower posterior region . |