| CTRI Number |
CTRI/2025/06/089696 [Registered on: 27/06/2025] Trial Registered Prospectively |
| Last Modified On: |
25/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Impact of gum disease treatment on blood sugar levels in non- diabetics with and without antibiotics |
|
Scientific Title of Study
|
Effect of Non-Surgical Periodontal Treatment on HbA1c Levels in Non-Diabetic Periodontitis Patients: A Comparative Study with and without Systemic Antibiotic Use |
| 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 Akansha R Jha |
| Designation |
Post Graduate Student |
| Affiliation |
Manubhai Patel Dental College and Hospital & ORI |
| Address |
Ground Floor Department of periodontics and implantology Manubhai Patel Dental College and Hospital and ORI Vishwajyoti ashram near vishwajyoti bridge mujmahuda Vadodara GUJARAT 390011 India
Vadodara
GUJARAT
390011
India |
| Phone |
8780160880 |
| Fax |
|
| Email |
jakansha35@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivlal Vishnoi |
| Designation |
Professor and Head |
| Affiliation |
Manubhai Patel Dental College and Hospital & ORI |
| Address |
Ground Floor Department of periodontics and implantology Manubhai Patel Dental College and Hospital and ORI Vishwajyoti ashram near vishwajyoti bridge mujmahuda Vadodara GUJARAT 390011 India
Vadodara
GUJARAT
390011
India |
| Phone |
9586869196 |
| Fax |
|
| Email |
vishnoi_shivlal@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivlal Vishnoi |
| Designation |
Professor and Head |
| Affiliation |
Manubhai Patel Dental College and Hospital & ORI |
| Address |
Ground Floor Department of periodontics and implantology Manubhai Patel Dental College and Hospital and ORI Vishwajyoti ashram near vishwajyoti bridge mujmahuda Vadodara GUJARAT 390011 India
Vadodara
GUJARAT
390011
India |
| Phone |
9586869196 |
| Fax |
|
| Email |
vishnoi_shivlal@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Dr Akansha R Jha Department of Periodontics and Implantology Manubhai Patel Dental College and Hospital & ORI Vishwajyoti ashram near vishwamitri bridge mujmahuda Vadodara GUJARAT 390011 India |
|
|
Primary Sponsor
|
| Name |
Dr Akansha R Jha |
| Address |
Ground Floor Department of periodontics and implantology Manubhai Patel Dental College and Hospital and ORI Vishwajyoti ashram near vishwajyoti bridge mujmahuda Vadodara GUJARAT 390011 India |
| 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 Akansha R Jha |
Manubhai Patel Dental College and Hospital & ORI |
Ground Floor Department of periodontics and implantology Manubhai Patel Dental College and Hospital and ORI Vishwajyoti ashram near vishwajyoti bridge mujmahuda Vadodara GUJARAT 390011 India
Vadodara
GUJARAT |
8780160880
jakansha35@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Systemically healthy patients with periodontitis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
HbA1c levels and other will be assessed at baseline and after 3 months |
comparing the HbA1c levels at baseline and after non surgical periodontal therapy with and without systemic antibiotics after 3 months |
| Intervention |
Non-Surgical Periodontal Treatment on HbA1c Levels in Non-Diabetic Periodontitis Patients with and without the use of antibiotics at baseline and 3 months |
Non-Surgical Periodontal Treatment on HbA1c Levels in Non-Diabetic Periodontitis Patients: A Comparative Study with and without Systemic Antibiotic use the HbA1c and other clinical parameters will be assessed at baseline and after 3 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Age more than or equal to 18 years
Systemically healthy
Periodontitis subjects: probing pocket depth more than or equal to 4mm
Presence of more than 18 natural teeth
Random blood sugar less than or equal to 140 mg/dl |
|
| ExclusionCriteria |
| Details |
History of diabetes mellitus or other systemic illness
History of antibiotic use or periodontal treatment with in the past six months
Pregnant and lactating patients
Smokers and alcoholics |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
HbA1c levels will be assessed before and after non-surgical periodontal therapy in patient with periodontitis at baseline and after 3 months
HbA1c levels will be assessed before and after non-surgical periodontal therapy with systemic antibiotic therapy in patient with periodontitis.
To compare the HbA1c levels in patient with periodontitis after non-surgical periodontal therapy with & without systemic antibiotic therapy at baseline and at 3 months.
|
At baseline and after 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| clinical parameters like Simplified Oral Hygiene Index (OHI-S),Gingival Index (GI),probing pocket depth (PPD) & clinical attachment level (CAL) from baseline to 3 months will be assessed. |
from baseline to 3 months. |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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 2 |
|
Date of First Enrollment (India)
|
28/07/2025 |
| 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="2"
Months="0"
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
|
To evaluate HbA1c levels and clinical parameters like OHI-S, GI, PPD and CAL in non diabetic patients with periodontitis undergoing non surgical periodontal treatment with and without systemic antibiotic use from baseline to 3 months. |