| CTRI Number |
CTRI/2023/12/060727 [Registered on: 26/12/2023] Trial Registered Prospectively |
| Last Modified On: |
21/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
PMS |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Analyse the changes in Saliva in pyorrhea patient after treated by scaling Therapy |
|
Scientific Title of Study
|
Comparative Evaluation of Levels of Salivary Visfatin and Aspartate Aminotransferase in Stage-II and Stage-III Periodontitis treated by Phase I Periodontal Therapy - A Prospective Clinical 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 Vivek Kanjibhai Bhesaniya |
| Designation |
MDS post graduate student |
| Affiliation |
Government Dental College and Hospital |
| Address |
Government Medical College campus , Government Dental college and hospital, Medical chowk - Nagpur
Nagpur
MAHARASHTRA
440003
India |
| Phone |
7984960804 |
| Fax |
|
| Email |
vivekbhesaniya7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mangesh B Phadnaik |
| Designation |
Professor & HOD department of Periodontology |
| Affiliation |
Government Dental College and Hospital |
| Address |
Government Dental college and hospital,near wanzari nagar Medical chowk - Nagpur
Nagpur
MAHARASHTRA
440003
India |
| Phone |
9422254404 |
| Fax |
|
| Email |
drmbphadnaik@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vivek Kanjibhai Bhesaniya |
| Designation |
MDS post graduate student |
| Affiliation |
Government Dental College and Hospital |
| Address |
Government Medical College campus , Government Dental Boys Hostel, Medical chowk - Nagpur
Nagpur
MAHARASHTRA
440003
India |
| Phone |
7984960804 |
| Fax |
|
| Email |
vivekbhesaniya7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College , Department of Biochemistry - Nagpur
|
| Government Dental College and Hospital , Department of Periodontology - Nagpur |
|
|
Primary Sponsor
|
| Name |
Dr Vivek Kanjibhai Bhesaniya |
| Address |
Government Medical College campus , Government Dental Boys Hostel, Medical chowk - Nagpur |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Mangesh B Phadnaik |
Government Dental College and Hospital , Medical chowk - Nagpur |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vivek Kanjibhai Bhesaniya |
Government dental college and hospital - Nagpur |
Periodontology department 202 PG section
Nagpur
MAHARASHTRA |
7984960804
vivekbhesaniya7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Government Dental College and Hospital Nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B998||Other infectious disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
All patient of Stage II Periodontitis will receive Phase-I periodontal therapy(Scaling and root planig procedure) |
Baseline:- Clinical parameters and biochemical parameters will
be recorded
Then Phase I therapy will be performed in Stage II periodontitis patients
After waiting for 1 month
2nd time Clinical parameters and biochemical parameters will
be recorded, evaluated and comparison will be done with baseline data of Stage II periodontitis patients |
| Intervention |
All patient of Stage III Periodontitis will receive Phase-I periodontal therapy (Scaling and root planing procedure) |
Baseline:- Clinical parameters and biochemical parameters will
be recorded
Then Phase I therapy will be performed in Stage III periodontitis patients
After waiting for 1 month
2nd time Clinical parameters and biochemical parameters will
be recorded, evaluated and comparison will be done with baseline data of Stage III periodontitis patients |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and female patients of age groups 18 to 70
years.
2. Minimum 20 teeth should be present.
3. Patient diagnosed as Stage-II or Stage-III
periodontitis.
4. Systemically healthy patients.
5. Patients ready to comply fully and willing to give consent form the final evaluation.
6. Patients having ability to maintain optimum oral hygiene. |
|
| ExclusionCriteria |
| Details |
1. Patients with systemic diseases.
2. Smoking and alcoholism
3. Teeth no less than 20.
4. Patients on antibiotics and anti-inflammatory drugs since 6 months.
5. Pregnant or lactating females.
6. Patients undergoing orthodontic treatment.
7. Those who have undergone periodontal surgical
treatment with in the last 6 months
8. Patient with obesity (BMI- more or equal to 30)
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Levels of Salivary Visfatin and
Aspartate Aminotransferase |
1st measurement at baseline and 2nd measurement at 4 weeks after Phase - I Periodontal therapy
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Probing pocket depth
2) Clinical attachment level
3) Gingival Index (Loe-Silness 1963) Score
4) Periodontal disease index
(Sigard Ramfjord 1959) Score
5) Oral hygiene
index-simplified (OHI-S) Score
|
1st measurement at baseline and 2nd measurement at 4 weeks after Phase - I Periodontal therapy
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/02/2024 |
| 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="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Periodontitis is one of the most prevalent oral diseases in the world. Approximately 5–20% of adults worldwide suffer from severe periodontitis which may lead to tooth loss. Biomarkers found in saliva can be evaluated to check for disease activity. Visfatin is a pre-B cell colony enhancing factor, a newly discovered adipokine released from adipose tissue, macrophages, and leukocytes. Aspartate aminotransferase (AST) is an enzyme that can be found in cells all over the body and there is a direct relation between AST level and quantity of tissue impairment. This biomarker will provides a safe, and non-invasive approach for periodontal disease detection, and possesses a high potential to revolutionize the next generation of diagnostics. Thus , the aim of this study was to evaluate the role of visfatin and Aspartate aminotransferase as best reliable diagnostic and prognostic biomarkers in oral diseases like periodontitis . |