| CTRI Number |
CTRI/2025/07/091821 [Registered on: 28/07/2025] Trial Registered Prospectively |
| Last Modified On: |
26/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Diagnostic
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
TO EVALUATE THE INFLUENCE OF ESTROGEN LEVELS IN POSTMENOPAUSAL FEMALES TREATED WITH CHITOSAN NANOPARTICLES DURING DENTAL IMPLANT PLACEMENT |
|
Scientific Title of Study
|
TO EVALUATE THE INFLUENCE OF ESTROGEN LEVELS IN POSTMENOPAUSAL FEMALES TREATED WITH CHITOSAN NANOPARTICLES DURING DENTAL IMPLANT PLACEMENT -A CONTROLLED CLINICAL 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 |
RUCHIKA |
| Designation |
MDS FIRST YEAR |
| Affiliation |
RAJASTHAN UNIVERSITY OF HEALTH AND SCIENCE |
| Address |
NEW ABADI STREET NO 7 OPPOSITE DURGA JYOTI TEMPLE HANUMANGARH TOWN 335513
SURENDERA DENTAL COLLEGE AND RESEARCH INSTITUTE HH GARDEN POWER HOUSE ROAD SRIGANGANAGAR RAJASTHAN
Ganganagar
RAJASTHAN
335513
India |
| Phone |
09462907457 |
| Fax |
|
| Email |
ruchikakataria16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR. RAJNI AGGARWAL |
| Designation |
PROFESSOR AND HEAD OF DEPARTMENT OF PERIODONTOLGY AND ORAL IMPLANTOLOGY |
| Affiliation |
SURENDERA DENTAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
HH GARDEN POWER HOUSE ROAD KARNI MARG SURENDERA DENTAL COLLEGE AND RESEARCH INSTITUTE ROOM NUMBER 4 SRIGANGANAGAR RAJASTHAN
Ganganagar
RAJASTHAN
335001
India |
| Phone |
9979470144 |
| Fax |
|
| Email |
rajniperio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
RUCHIKA |
| Designation |
MDS FIRST YEAR |
| Affiliation |
SURENDERA DENTAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
NEW ABADI STREET NO 7 OPPOSITE DURGA JYOTI TEMPLE HANUMANGARH TOWN 335513
SURENDERA DENTAL COLLEGE AND RESEARCH INSTITUTE HH GARDEN POWER HOUSE ROAD SRIGANGANAGAR RAJASTHAN
Ganganagar
RAJASTHAN
335513
India |
| Phone |
09462907457 |
| Fax |
|
| Email |
ruchikakataria16@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF PERIODONTOLOGY AND ORAL IMPLANTOLOGY ROOM NUMBER 4 OF SURENDERA DENTAL COLLEGE AND RESEARCH INSTITUTE SRIGANGANAGAR |
|
|
Primary Sponsor
|
| Name |
RUCHIKA |
| Address |
SURENDERA DENTAL COLLEGE AND RESEARCH INSTITUTE HH GARDEN POWER HOUSE ROAD SRIGANGANAGAR RAJASTHAN |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| SURENDERA DENTAL COLLEGE AND RESEARCH INSTITUTE |
HH GARDEN POWER HOUSE ROAD KARNI MARG SURENDERA DENTAL COLLEGE AND RESEARCH INSTITUTE SRIGANGANAGAR RAJASTHAN 335001 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| RUCHIKA |
SURENDERA DENTAL COLLEGE AND RESEARCH INSTITUTE |
DEPARTMENT OF PERIODONTOLOGY AND ORAL IMPLANTOLOGY ROOM NO. 4 SRIGANGANAGAR RAJASTHAN 335001
Ganganagar
RAJASTHAN |
09462907457
ruchikakataria16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
free of any systemic disease and willing to participate in the study |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
to evaluate the influence of estrogen hormones on dental implant placement in female patients under local anaesthesia |
ideal dental implant procedure in female patient through clinical and radiographic evaluation followed by local anaesthesia usually 2%lidocaine with epinephrine maximum 420mg for 60 kg patient ,2-3 cartridgesused .a full thickness flap is raised ostetomy is done using sequential drills under irrigation,and implant is placed 35-45Ncm torque depending on protocol a healing abutment or cover screw is placed,flap is sutured.post operative care included antibiotics,analagesics,and chlorhexidine mouthwash. |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
females wanted and in need of dental implant placemrnt of both groups premenopausal and postmenopausal |
|
| ExclusionCriteria |
| Details |
with any systemic disease
or any bone disorder |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to evaluate the influence of estrogen levels on stability of dental implant placement |
MARGINAL BONE LOSS WILL BE CHECKED AFTER 1,3,6,9 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to check the effects of chitosan as bone graft in dental implant placement |
to check bone stability after 1,3,6,,9 months |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/09/2025 |
| 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="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - NO
|
|
Brief Summary
|
6.1 AIM: - To
evaluate the influence of estrogen levels in postmenopausal females treated
with chitosan nanoparticles during dental implant placement - a controlled
clinical trial.
OBJECTIVE:
1) To evaluate
the effect of hormones (estrogen) in females of different age Groups i.e. Pre-
menopausal and post-menopausal
2) To evaluate
the effect of chitosan
(Nanoparticles) in Dental Implants stability
3) To
comparatively evaluate the effect of chitosan (Nanoparticles) in female
Patients in post- menopause |