| CTRI Number |
CTRI/2020/04/024502 [Registered on: 07/04/2020] Trial Registered Prospectively |
| Last Modified On: |
09/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Crestal bone changes around dental implants in different soft tissue biotype |
|
Scientific Title of Study
|
Assessment of crestal bone changes around dental implants in different soft tissue biotype:a 12 months follow up study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jigna Dodiya |
| Designation |
PG Student |
| Affiliation |
Manubhao Patel Dental College |
| Address |
DEPARTMENT OF PERIODONTOLOGY AND ORAL IMPLANTOLOGY MANUBHAI PATEL DENTAL COLLEGE
NEAR VISHWAJYOTI ASHRAM
VISHWAMITRI BRIDGE ROAD
MUNJ MAHUDA
VADODARA
NEAR VISHWAJYOTI ASHRAM
VISHWAMITRI BRIDGE ROAD
MUNJ MAHUDA
VADODARA
Vadodara
GUJARAT
390011
India |
| Phone |
7096897209 |
| Fax |
|
| Email |
jignadodiya19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivlal Vishnoi |
| Designation |
Proffessor |
| Affiliation |
Manubhai Patel Dental College and hospital |
| Address |
DEPARTMENT OF PERIODONTOLOGY AND ORAL IMPLANTOLOGY
MANUBHAI PATEL DENTAL COLLEGE
NEAR VISHWAJYOTI ASHRAM
VISHWAMITRI BRIDGE ROAD
VADODARA
NIL
Vadodara
GUJARAT
390011
India |
| Phone |
9586869196 |
| Fax |
|
| Email |
vishnoi_shivlal@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jigna Dodiya |
| Designation |
PG Student |
| Affiliation |
Manubhai Patel Dental College and hospital |
| Address |
Department of periodontology and oral implantology
Manubhai Patel Dental College
Near Vishwajyoti Ashram
Vishwamitri Bridge Road
Vadodara
nil
Vadodara
GUJARAT
390011
India |
| Phone |
7096897209 |
| Fax |
|
| Email |
jignadodiya19@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Manubhai Patel Dental College and Hospital Vadidara |
| Address |
Manubhai Patel Dental College and Hospital and oral research center, Near Vishvajyoti Ashram, Vishwamitri bridge, Vadodara. |
| Type of Sponsor |
Research institution |
|
|
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 Jigna Dodiya |
Manubhai Patel Dental college and Hospital |
Manubhai Patel Dental College
Department of periodontology and oral implantology
Near Vishwajyoti Ashram
Vishwamitri bridge road
vadodara
Vadodara
GUJARAT |
7096897209
jignadodiya19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maharaja Krishnakumarsinhji Bhavnagar University Ethics Committee For MDS Course And Dental Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Partially edentulous alveolar ridge |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Edentulous spaces should be present
Good periodontal health
adequate amount of bone for implant placement
who were willing to provode informed consent |
|
| ExclusionCriteria |
| Details |
patient requiring ridge augmentation with barrier membranes or bone grafts
patient with a history of diabetes or any other debilitating systemic diseases
pregnancy or lactation
infection on implant site
history of bruxism |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
mucosal thickness
crestal bone loss
|
Mucosal thicknes will be assessed at baseline
crestal bone loss will be assessed at 3 months.6 months and 12 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="27" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
07/04/2020 |
| Date of Study Completion (India) |
30/01/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is designed to evaluate crestal bone changes around implants in different soft tissue biotype. Total 30 patient will be enrolled for study. According to the measurement of biotype the patients will be devided in two groups. Group A contain Thick biotype which is more then 2 mm of thickness while group B contains thin biotype which is less then 2 mm of thickness. Biotype will be measure at the time of implant placement. After that crestal bone changes will be measure with the help of digital radiographs at the baseline. 3 months, 6 months and 12 months after implant placement. |