| CTRI Number |
CTRI/2025/05/087637 [Registered on: 26/05/2025] Trial Registered Prospectively |
| Last Modified On: |
26/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation of association between the waist circumference and waist to height ratio in stage III/IV Periodontitis Patients with and without Type 2 Diabetes Mellitus. |
|
Scientific Title of Study
|
Comparative Evaluation of Waist Circumference and Waist to height ratio in Stage III/IV periodontitis with and without Type 2 Diabetes Mellitus. |
| 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 Kamalkishor Mankar |
| Designation |
Professor and Guide |
| Affiliation |
Ranjeet Deshmukh Dental College and Research Centre, Nagpur |
| Address |
104, Department of Periodontics and Implantology, Ranjeet Deshmukh Dental College and Research Centre, Digdoh Hills, Hingna Road, Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9850061038 |
| Fax |
|
| Email |
drkamalk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kamalkishor Mankar |
| Designation |
Professor and Guide |
| Affiliation |
Ranjeet Deshmukh Dental College and Research Centre, Nagpur |
| Address |
104, Department of Periodontics and Implantology, Ranjeet Deshmukh Dental College and Research Centre, Digdoh Hills, Hingna Road, Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9850061038 |
| Fax |
|
| Email |
drkamalk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kamalkishor Mankar |
| Designation |
Professor and Guide |
| Affiliation |
Ranjeet Deshmukh Dental College and Research Centre, Nagpur |
| Address |
104, Department of Periodontics and Implantology, Ranjeet Deshmukh Dental College and Research Centre, Digdoh Hills, Hingna Road, Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9850061038 |
| Fax |
|
| Email |
drkamalk@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Self Ranjeet Deshmukh Dental College and Research Centre Nagpur |
| Address |
104, Department of Periodontics and Implantology, Ranjeet Deshmukh Dental College, Digdoh Hills, Hingna Road, Nagpur. |
| 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 ANUSHREE MATRE |
Ranjeet Deshmukh Dental College and Research Centre |
104 Department of Periodontics and Implantology
Nagpur
MAHARASHTRA |
07972876856
dranushreematre@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: E116||Type 2 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Healthy Patients |
Patients without Periodontitis or any systemic diseases |
| Intervention |
Periodontitis stage III Patients |
Patients with periodontitis stage III patients with type 2 Diabetes Mellitus |
| Intervention |
Periodontitis stage IV Patients |
Patients with periodontitis stage IV patients with type 2 Diabetes Mellitus |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients who are willing to participate and sign the informed consent for this clinical trial.
2.Patients with Type 2 Diabetes Mellitus
3.Patients with Stage III/IV Periodontitis
4.Systematically healthy patients. |
|
| ExclusionCriteria |
| Details |
1.Patients with known systemic diseases (other than T2DM) and conditions.
2.Patients who received systemic antibiotic therapy within the past 6 months
3.Patients who received periodontal therapy (scaling and root planning or surgery) within the past year.
4.Self-reported psychiatric disorder or psychotic medications.
5.Pregnancy and lactating mothers, current smokers. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the WC and WHtR in periodontally healthy, stage III/IV periodontitis with and without Type 2 Diabetes Mellitus patients. |
To evaluate and compare the WC and WHtR in periodontally healthy, stage III or stage IV periodontitis with and without Type 2 Diabetes Mellitus patients at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
09/06/2025 |
| 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="0"
Months="6"
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 aimed to compare the Waist circumference and Waist to Height ratio in stage III/IV periodotitis with and without Type 2 diabetes mellitus along with healthy patients. Any association between WC and WHtR in Periodontally healthy, Stage III/IV periodontitis patients with and without Type 2 Diabetes Mellitus is seen. Gingival Index, Plaque Index, Probing Pocket Depth, Clinical Attachment Level, HbA1C levels; height, weight and waist circumference; and BMI is assessed and WC and WHtR with Periodontal parameters and HbA1C levels were compared. Patients visiting in Department of Periodontology and Implantology, RD DCRC, Nagpur and Department of General Medicine NKP SIMS, Nagpur as per inclusion criteria will be included in the study groups. 3 groups were included: Group I (30 Participants) Periodontally Healthy patients Group II (30 Participants) Stage III/IV Periodontitis without Type 2 DM Group III (30 Participants) Stage III/IV Periodontitis with Type 2 DM. Total 90 participants including periodontally healthy, Stage III/IV periodontitis with and without Type 2 Diabetes Mellitus, as per the inclusion criteria will participate in the study. Clinical parameters such as Gingival Index and Plaque Index will be measured; Probing Pocket Depth and Clinical Attachment Level will be measured using UNC 15 periodontal probe. Other parameters such as HbA1C Levels; height, weight and waist circumference will be evaluated and BMI will be measured and compared. The data will be statistically analysed after completion of the study.
|