| CTRI Number |
CTRI/2024/06/068538 [Registered on: 06/06/2024] Trial Registered Prospectively |
| Last Modified On: |
10/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To assess the oral health Status in Pre and Post Menopausal Females with bone loss |
|
Scientific Title of Study
|
Evaluation of Periodontal health Status in Pre and Post Menopausal Females with Periodontitis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tanu Sahney |
| Designation |
Senior Lecturer |
| Affiliation |
Sardar Patel Post Graduate Institute of Dental and Medical Sciences |
| Address |
Room no 7, Department of Periodontology
Sardar Patel Post Graduate Institute of Dental and Medical Sciences
Chaudhary Vihar, Utrathia,
Raebareily Road,
Lucknow – 226025 – Uttar Pradesh
Lucknow
UTTAR PRADESH
226025
India |
| Phone |
8004354413 |
| Fax |
|
| Email |
tanu.sahney0111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tanu Sahney |
| Designation |
Senior Lecturer |
| Affiliation |
Sardar Patel Post Graduate Institute of Dental and Medical Sciences |
| Address |
Room no 7, Department of Periodontology, Sardar Patel Post Graduate Institute of Dental and Medical Sciences
Chaudhary Vihar, Utrathia,
Raebareily Road,
Lucknow – 226025 – Uttar Pradesh
Lucknow
UTTAR PRADESH
226025
India |
| Phone |
8004354413 |
| Fax |
|
| Email |
tanu.sahney0111@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tanu Sahney |
| Designation |
Senior Lecturer |
| Affiliation |
Sardar Patel Post Graduate Institute of Dental and Medical Sciences |
| Address |
Room no 7, Department of Periodontology, Sardar Patel Post Graduate Institute of Dental and Medical Sciences
Chaudhary Vihar, Utrathia,
Raebareily Road,
Lucknow – 226025 – Uttar Pradesh
Lucknow
UTTAR PRADESH
226025
India |
| Phone |
8004354413 |
| Fax |
|
| Email |
tanu.sahney0111@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Periodontology, Sardar Patel Post Graduate Institute of Dental and Medical Sciences
Chaudhary Vihar, Utrathia,
Raebareily Road,
Lucknow – 226025 – Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
Tanu Sahney |
| Address |
Sardar Patel Post Graduate Institute of Dental and Medical Sciences
Chaudhary Vihar, Utrathia,
Raebareily Road,
Lucknow – 226025 – Uttar Pradesh |
| Type of Sponsor |
Other [Self] |
|
|
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 Tanu Sahney |
Sardar Patel Post Graduate Institute of Dental and Medical Sciences, Lucknow |
Chaudhary Vihar, Utrathia, Raebareily Road, Lucknow – 226025
Chaudhary Vihar, Utrathia,
Raebareily Road,
Lucknow – 226025 – Uttar Pradesh
Lucknow
UTTAR PRADESH |
8004354413
tanu.sahney0111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Sardar Patel Post Graduate Institute of Dental and Medical Sciences, Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Chronic Periodontitis |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1. Female patient diagnosed with chronic periodontitis
2. The sites should exhibit clinical evidence of probing pocket depth of ≥5mm and clinical attachment loss ≥3mm.
3. Age between 20 and 60 years
4. Systemically healthy patients
5. Patients with established willingness and ability to perform adequate oral hygiene
|
|
| ExclusionCriteria |
| Details |
1. Patients who have received antibiotic therapy within the past six months
2. Pregnant and lactating patients
3. Smokers and tobacco chewers
4. Patients who demonstrate poor oral hygiene maintenance after Phase I therapy
5. Systemic illness known to affect the outcomes of periodontal therapy; such as uncontrolled diabetes mellitus, cardiac diseases, immune-compromised (e.g., HIV individuals, under radiotherapy), patients taking medications such as corticosteroids or calcium channel blockers, which are known to interfere with periodontal wound healing.
6. Patients with any known allergy to drugs.
7. Patients with gross oral pathology or tumors.
8. Patients undergoing hormone replacement therapy.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Endogenous sex steroid hormones can alter their responses to local factors such as the presence of microbial plaque and also regulate the responses of periodontal tissues as well. Hence, prophylactic precautions and early intervention of oral diseases can show promising results in maintaining good oral health for all women. |
first day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The effect of sex hormones can be reduced with regular dental examination, maintaining good oral hygiene, and hormonal replacement therapies. |
first day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
20/06/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Periodontal disease is associated with various risk factors among which female hormonal alteration such as menopause have been found to be connected with periodontal breakdown and osteoporosis. The aim of the study will be to determine the periodontal status in pre and post menopausal females. In this study, thirty female patients aged between 40 to 60 years visiting Department of Periodontology, SPPGIDMS, Lucknow and diagnoses with periodontitis showing Probing pocket depth >5 mm and Clinical attachment level > 4mm will be included. The patients will be divided into two groups - Group 1 comprising of 15 pre menopausal female patients with chronic periodontitis and Group II comprising of 15 post menopausal females with chronic periodontitis. Oral examination and clinical parameters such as Gingival Index (GI), Plaque Index (PI), Probing pocket depth and clinical attachment level will be assessed with a UNC 15 periodontal probe. Sex hormones can alter their responses to local factors such as presence of microbial plaque and also regulate the responses of periodontal tissues. Hence early intervention of oral diseases and prophylactic measures can show promising results in maintaining good oral health for females. |