| CTRI Number |
CTRI/2023/12/060799 [Registered on: 27/12/2023] Trial Registered Prospectively |
| Last Modified On: |
26/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
PLACEMENT OF IMPLANT WITH OR WITHOUT HYALURONIC ACID |
|
Scientific Title of Study
|
EFFICACY OF ADDITIONAL USE OF HYALURONIC ACID GEL ON HARD AND SOFT TISSUE CHANGES AROUND DENTAL IMPLANTS: 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 Mayank Gupta |
| Designation |
Post Graduate Student |
| Affiliation |
Institute of Dental Studies and Technologies |
| Address |
Department of Periodontology Institute of Dental Studies and Technologies
Kadrabad
Modinagar
Ghaziabad
Ghaziabad
UTTAR PRADESH
201201
India |
| Phone |
09899817505 |
| Fax |
|
| Email |
drmayankguptaraj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manish Khatri |
| Designation |
Professor and HOD |
| Affiliation |
Institute of Dental Studies and Technologies |
| Address |
Department of Periodontology Institute of Dental Studies and Technologies
Kadrabad
Modinagar
Ghaziabad
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
Ghaziabad
UTTAR PRADESH
201201
India |
| Phone |
9871655313 |
| Fax |
|
| Email |
drmansibansal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Dental Studies and Technologies
Address: Room no 7,Department of Periodontics, NH-58, Delhi-Meerut Road,
Kadrabad, Modinagar, Uttar Pradesh, India-201201 |
|
|
Primary Sponsor
|
| Name |
Institute of Dental Studies and Technologies |
| Address |
Room no 7,Department of Periodontics, NH-58, Delhi-Meerut Road,
Kadrabad, Modinagar, 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 Mayank Gupta |
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
Ghaziabad
UTTAR PRADESH |
09899817505
drmayankguptaraj@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
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K084||Partial loss of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Implant with hyaluronic acid gel |
1 ml of Hyaluronic acid (HA) gel of medical/surgical grade will be applied on the implant surface and into the osteotomy site for 2 minutes before placement of the implants in Experimental Group. Hyaluronic acid is applied on the implant surface and osteotomy site so as to completely wet them. |
| Comparator Agent |
Implant without hyaluronic acid gel |
Implant supported oral
rehabilitation has increasingly
improved the treatment options
for edentulous patient, reporting
high long term survival and
success rates |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with good oral hygiene will be included if they are systemically healthy and have minimum two or even multiple number of missing teeth with adequate inter-occlusal clearance (distance between opposing teeth and edentulous space). |
|
| ExclusionCriteria |
| Details |
Patients will be excluded if they are smokers or have 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 will also be excluded from the study. |
|
|
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
mesial and distal crestal bone level
Probing depths at four sites |
For bone density and mesial and distal crestal bone level at baseline(immediately after implant placement), 1 month, 3 months and 6 months
Probing depths at baseline(just after prosthesis placement), 1 month and 3 months after prosthesis placement |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Modified Plaque index
Simplified Gingival Index
Modified Sulcular Bleeding Index |
baseline ( at the time of crown placement),1
month,3 month |
|
|
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)
|
08/01/2024 |
| 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="0"
Months="7"
Days="20" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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. Mayank Gupta, Dr. Manish Khatri, Dr. Mansi Bansal, Dr. Vimal Kumar and Dr. Pratiksha Tripathi at 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 Hyaluronic acid gel on implants. Hyaluronic acid is used as a coating, acts on migration, adhesion, proliferation and differentiation of cellular precursors on titanium implants improving the connection between implant and bone. Assessment and comparison of various parameters like bone density, crestal heights, probing depth around implants will be done. |