| CTRI Number |
CTRI/2024/06/069285 [Registered on: 20/06/2024] Trial Registered Prospectively |
| Last Modified On: |
18/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Effect of non-surgical periodontal therapy on galectin-3 and tumor necrosis factor–α levels in periodontitis patients with and without type 2 diabetes mellitus - A clinico-biochemical study. |
|
Scientific Title of Study
|
Effect of non-surgical periodontal therapy on galectin-3 and tumor necrosis factor–α levels in gingival crevicular fluid of periodontitis patients with and without type 2 diabetes mellitus - A clinico-biochemical study. |
| 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 Divya Shonima |
| Designation |
Post Graduate 1st year MDS |
| Affiliation |
The Oxford Dental College, Bangalore |
| Address |
Room no - 3 , Department of Periodontology
2nd floor , The Oxford Dental College , Bommanahalli , Bangalore - 560068
Bangalore
KARNATAKA
560068
India |
| Phone |
9102403502 |
| Fax |
|
| Email |
24divyashonima@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Savitha A N |
| Designation |
Faculty , MDS Periodontology |
| Affiliation |
The Oxford Dental College, Bangalore |
| Address |
Room no - 3 , Department of Periodontolgy ,
2nd Floor , The Oxford Dental College ,
Bommanahalli ,
Bangalore , Karnataka - 560068
Bangalore
KARNATAKA
560068
India |
| Phone |
9102403502 |
| Fax |
|
| Email |
24divyashonima@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Divya Shonima |
| Designation |
Post Graduate 1st year MDS |
| Affiliation |
The Oxford Dental College, Bangalore |
| Address |
Room no - 905, B Block, Oxford girls hostel, The Oxford Dental College, Bommanahalli, Bangalore, Karnataka
Bangalore
KARNATAKA
560068
India |
| Phone |
9102403502 |
| Fax |
|
| Email |
24divyashonima@gmail.com |
|
|
Source of Monetary or Material Support
|
| The Oxford Dental College and Hospital, Bommanahalli, Bangalore, Karnataka - 560068 |
|
|
Primary Sponsor
|
| Name |
Dr Divya Shonima |
| Address |
Room no - 905 , B Block , Oxford Girls Hostel
The Oxford Dental College , Bommanahalli
Bangalore , Karnataka - 560068 |
| 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 Divya Shonima |
The Oxford Dental College |
Room no - 3, Dept of Periodontology,
2nd floor,
The Oxford Dental College ,
Bommanahalli,
Bangalore
Karnataka - 560068
Bangalore
KARNATAKA |
9102403502
24divyashonima@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, (2) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Non surgical periodontal therapy
( Scaling ) |
NSPT is done using piezo ultra-sonic scaler on the healthy subjects, periodontitis patients with and without type 2 diabetes mellitus at the baseline and after 3 months the subject is recalled to assess the levels of Galectin-3 and TNF alpha in GCF. Total duration of study will be 3 months . |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
a) Subjects of either gender, between the ages of 20 and 60 years.
i. Presence of at least 20 natural teeth.
ii. Healthy subjects with clinical parameters of bleeding on probing less than 10 % and probing depth less than or equal to 3 mm
iii. Patients with diagnosis of generalised stage III grade B periodontitis with clinical parameters of probing depth more than or equal to 6 mm and clinical attachment loss more than or equal to 5 mm
b) Subjects with type 2 diabetes mellitus ( HbA1c more than or equal to 6.4 % but less than 7 % ) |
|
| ExclusionCriteria |
| Details |
a) Individuals with systemic diseases other than T2DM
b) Obese individuals, BMI more than 25 kg/m2
c) Smokers
d) Pregnant/Lactating and postmenopausal women
e) Individuals who have received periodontal therapy in the last 6 months
f) Individuals who have had a history of antimicrobial and anti-inflammatory therapy in last 6 months |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Galectin-3 and TNF alpha levels in GCF |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Clinical parameters - Gingival index, bleeding on probing, probing depth and clinical attachment loss |
3 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
15/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/07/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
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
|
This study is a non randomized , parallel group trial showing the effect of Non surgical periodontal therapy on the levels of Galectin-3 and Tumor necrosis factor alpha in GCF of periodontitis patients with and without type 2 diabetes mellitus . It will be conducted in The Oxford Dental College , Bangalore in India and the duration for the completion of study will be 3 months. The primary outcome measure will be Galectin-3 and TNF alpha levels before and after NSPT following 3 months. The secondary outcome measure will be clinical parameters - Gingival index, bleeding on probing, probing depth and clinical attachment loss before and after NSPT following 3 months. |