| CTRI Number |
CTRI/2023/03/050997 [Registered on: 23/03/2023] Trial Registered Prospectively |
| Last Modified On: |
03/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
PLACEMENT OF IMPLANT WITH OR WITHOUT blue® m gel |
|
Scientific Title of Study
|
"EFFICACY OF ADDITIONAL USE OF blue® m gel ON HARD AND SOFT TISSUE CHANGES AROUND DENTAL IMPLANT: AN IN VIVO 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 Roshi Talwar |
| Designation |
Post Graduate Student |
| Affiliation |
Institute of Dental Studies and Technologies |
| Address |
Department of Periodontology, Institute of Dental Studies and Technologies, Kadrabad, Modinagar Ghaziabad UTTAR PRADESH
Ghaziabad
UTTAR PRADESH
201201
India |
| Phone |
9805145391 |
| Fax |
|
| Email |
roshitalwar2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manish Khatri |
| Designation |
Professor & HOD |
| Affiliation |
Institute of Dental Studies and Technologies |
| Address |
Department of periodontology, Institute of Dental Studies and Technologies, Kadrabad, Modinagar Ghaziabad UTTAR PRADESH
Department of periodontology, Institute of Dental studies and Technologies, Kadrabad, Modinagar Ghaziabad UTTAR PRADESH
Ghaziabad
UTTAR PRADESH
201201
India |
| Phone |
9810720335 |
| Fax |
|
| Email |
drmanishkhatri@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mansi Bansal |
| Designation |
Professor |
| Affiliation |
Institute of Dental Studies and Technologies |
| Address |
Department of Periodontology, Institute of Dental Studies and Technologies, Kadrabad, Modinagar Ghaziabad UTTAR PRADESH
Ghaziabad
UTTAR PRADESH
201201
India |
| Phone |
9871655313 |
| Fax |
|
| Email |
drmansibansal@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Institute of Dental Studies and Technologies |
| Address |
Room no 7,Department of Periodontics, NH-58, Delhi-Meerut Road, Kadrabad, Uttar Pradesh, India-201201 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Roshi Talwar |
Institute of Dental Studies and Technologies |
Department of Periodontology, Room no 7, Institute of Dental Studies and Technologies, Modinagar, Uttar Pradesh, India Ghaziabad UTTAR PRADESH
Ghaziabad
UTTAR PRADESH |
9805145391
roshitalwar2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IDST Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Subjects with minimum two or even multiple number of edentulous spaces |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Placement of implant with blue® m gel application |
Commercially available blue® m gel will be applied on the implant surface and into the osteotomy site before placement of the implants. |
| Comparator Agent |
Placement of implant without blue® m gel application. |
Implants will be placed without the application of blue® m gel |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Good oral hygiene
Systemically healthy
Minimum two or even multiple number of missing teeth with adequate inter-occlusal clearance |
|
| ExclusionCriteria |
| Details |
Smokers
Para-functional habits
Uncontrolled diabetes
Blood disorders
Immune-compromised state
Acute infection at site or aggressive periodontal disease
Patients on bisphosphonates, pregnant and lactating women
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
bone density
crestal bone level
Probing depths at four sites |
bone density and crestal bone level on the day of implant placement, on the day of prosthesis placement and at 3 months of prosthesis placement
Probing depths at four sites at the time of placement of prosthesis, after 1 and 3 months of placement of prosthesis |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Modified Plaque index
Simplified Gingival Index
Modified Sulcular Bleeding Index |
Baseline(at the time of prosthesis placement),after 1 and 3 months of placement of prosthesis. |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
27/03/2023 |
| 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="0"
Months="7"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study will be conducted and compiled by Dr. Roshi Talwar, Dr. Manish Khatri, Dr. Mansi Bansal, Dr. Sakshi Gaind, Dr. Paras Verma, Dr. Mohd Rehan , Dr. Sourabh mehrotra ,Dr. Pratiksha Tripathi, Department of Periodontology, Institute of Dental Studies and Technologies, Modinagar, Uttar Pradesh, India The study is a randomized control trial for evaluation of efficacy of blue m gel on implants. Assessment and comparison of various parameters will be done. |