| CTRI Number |
CTRI/2024/09/074148 [Registered on: 23/09/2024] Trial Registered Prospectively |
| Last Modified On: |
20/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Examining the gum health of diabetics with varying blood sugar levels |
|
Scientific Title of Study
|
Assessment of periodontal health status in type 2 diabetes mellitus patients with glycemic levels. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SHAZIA BEGUM SHAIK |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
SIBAR INSTITUTE OF DENTAL SCIENCES |
| Address |
DEPARTMENT OF PERIODONTOLOGY,
ROOM-NO 8,
SECOND FLOOR,
SIBAR INSTITUTE OF DENTAL
SCIENCES,
TAKKELLAPADU,
GUNTUR,
ANDHRA PRADESH,
India,
Pin code-522509
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
7013083810 |
| Fax |
|
| Email |
shaziashaik13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR BOYAPATI RAMANARAYANA |
| Designation |
PROFESSOR |
| Affiliation |
SIBAR INSTITUTE OF DENTAL SCIENCES |
| Address |
DEPARTMENT OF PERIODONTOLOGY,
ROOM-NO 8,
SECOND FLOOR,
SIBAR INSTITUTE OF DENTAL
SCIENCES,
TAKKELLAPADU,
GUNTUR,
ANDHRA PRADESH,
India,
Pin code-522509
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9490144365 |
| Fax |
|
| Email |
dr.ramanarayana@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR BOYAPATI RAMANARAYANA |
| Designation |
PROFESSOR |
| Affiliation |
SIBAR INSTITUTE OF DENTAL SCIENCES |
| Address |
DEPARTMENT OF PERIODONTOLOGY,
ROOM-NO 8,
SECOND FLOOR,
SIBAR INSTITUTE OF DENTAL
SCIENCES,
TAKKELLAPADU,
GUNTUR,
ANDHRA PRADESH,
India,
Pin code-522509
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9490144365 |
| Fax |
|
| Email |
dr.ramanarayana@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sibar Institute of Dental Sciences,Takkellapadu,Guntur, Andhra Pradesh,India,PINCODE-522509 |
|
|
Primary Sponsor
|
| Name |
DR SHAIK SHAZIA BEGUM |
| Address |
DEPARTMENT OF PERIODONTOLOGY,
ROOM-NO 8,
SECOND FLOOR,
SIBAR INSTITUTE OF DENTAL
SCIENCES,
TAKKELLAPADU,
GUNTUR,
ANDHRA PRADESH,
India,
Pin code-522509 |
| 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 Shaik Shazia Begum |
Sibar Institute of Dental Sciences |
Department of Periodontology,Second
floor,Room number-8,Sibar Institute of Dental Sciences,
Takkellapadu,Guntur,Andhra Pradesh,India,PIN CODE-522509
Guntur
ANDHRA PRADESH |
7013083810
shaziashaik13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sibar Institute of Dental Sciences, Guntur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
not applicable |
not applicable |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects with history of diabetes past 2 years or more
2.Patients aged 35 to 60 years
3.Patients who are willing to participate in the study
|
|
| ExclusionCriteria |
| Details |
1.Subjects using any form of tobacco.
2.Subjects with any other systemic diseases and medication
3.Subjects who underwent periodontal therapy past 1 year
4.Subjects with history of tooth loss due to trauma or dental caries or orthodontic
extractions.
5.Subjects who are under medication for Thiazolidinediones
6.Pregnant woman and Lactating mothers |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessing the periodontal health status using clinical and radiographic parameters in
patients with type 2 diabetes of varying glycemic levels |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessing the number of tooth lost in patients with type 2 diabetes of varying glycemic levels |
3 months
|
|
|
Target Sample Size
|
Total Sample Size="159"
Sample Size from India="159"
Final Enrollment numbers achieved (Total)= "159"
Final Enrollment numbers achieved (India)="159" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/10/2024 |
| Date of Study Completion (India) |
20/01/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
The effect of diabetes on periodontium has been thoroughly investigated and confirmed as a major risk factor for periodontitis.On the other hand, periodontal disease may be a possible risk factor for poor glycemic control and promote the existence of diabetic complications.In patients with type 2 diabetes, severe periodontitis was associated with significant worsening of glycemic control over time.The high concentration of glucose in the fluid of gingival crevicular is due to the levels of glucose high in the plasma and it weakens the capacity of healing in fibroblasts of the periodontium, which is responsible for the health maintenance of the tissues.the gingival capillaries thickness increase in the patients having diabetes which possibly limit the diffusion of the nutrients and the oxygen supply and that causes the immune capacity to limited in the periodontal tissues.Various literature studies have assessed the correlation between diabetic patients and periodontal health through radiographical assessment and the efficiency of healing during periodontal interventions. But there still exists an ambiguity in the correlation between the glycemic levels of patients and its influence on the periodontal health. This prospective clinical study assesses the effect of blood glycemic levels as evaluated from HbA1c levels on the various clinical and radiographic parameters evaluating bone loss for periodontal status. |