| CTRI Number |
CTRI/2024/05/068142 [Registered on: 31/05/2024] Trial Registered Prospectively |
| Last Modified On: |
31/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparing Gum Health in People with High Blood Sugar, border line and Normal Blood Sugar |
|
Scientific Title of Study
|
Comparative Evaluation of Periodontal Status among Prediabetic Diabetic AND Non-Diabetic Subjects |
| 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 Mohamed Nawfal |
| Designation |
Postgraduate student |
| Affiliation |
Yenepoya Dental College |
| Address |
Room no 7
2nd floor
Department of Periodontology
Yenepoya Dental College
Yenepoya University
Mangalore
Dakshina Kannada
Karnataka
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8940113111 |
| Fax |
|
| Email |
mdnawfal97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shashikanth Hegde |
| Designation |
Professor |
| Affiliation |
Yenepoya Dental College |
| Address |
Room no 7
2nd floor
Department of Periodontology
Yenepoya Dental College
Yenepoya University
Mangalore
Dakshina Kannada
Karnataka
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7846870977 |
| Fax |
|
| Email |
drshashikanthhegde@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shashikanth Hegde |
| Designation |
Professor |
| Affiliation |
Yenepoya Dental College |
| Address |
Room no 7
2nd floor
Department of Periodontology
Yenepoya Dental College
Yenepoya University
Mangalore
Dakshina Kannada
Karnataka
KARNATAKA
575018
India |
| Phone |
7846870977 |
| Fax |
|
| Email |
drshashikanthhegde@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of periodontology , Yenepoya dental college,
mangalore-575018
karnataka,
India. |
|
|
Primary Sponsor
|
| Name |
Dr Mohamed Nawfal |
| Address |
Yenepoya Dental College
mangalore-575018
karnataka,
India. |
| Type of Sponsor |
Other [Self funded ] |
|
|
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 Mohamed Nawfal |
Yenepoya Dental college |
Room 7
2nd floor
Department of Periodontology
Yenepoya Dental College
Yenepoya University
Mangalore
Dakshina Kannada
KARNATAKA |
8940113111
mdnawfal97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya ethics committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Individual with medically diagnosed prediabetes (HbA1c levels between 5.7% and 6.4%) [11]
2. Individuals with medically diagnosed TYPE 2 diabetes mellitus (HbA1c levels ≥ 6.5%) [11]
3. Nondiabetic controls (HbA1c levels <5.7%) [11]
4. Age-25 to 60 years.
5. Volunteers who are willing to participate in the study.
6. Subjects with minimum of 14 teeth will be included in the study
|
|
| ExclusionCriteria |
| Details |
1. Patients with self-reported systemic diseases such as acquired immune deficiency syndrome,
Cardiovascular disorders, hepatic disorders and renal disorders.
2. Use of antibiotics and/or steroids within the past 90 days.
3. Patients who had undergone periodontal therapy within the past 90 days.
4. Habitual alcohol and tobacco use.
5. Pregnancy and/or lactation.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The severity of periodontal disease, typically assessed using clinical parameters such as probing depth (PD)and clinical attachment loss (CAL). This would involve comparing the mean PD and CAL scores among prediabetic, diabetic, and non-diabetic groups. |
baseline assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| glycemic control measure , oral hygiene indices & radiographic assessment |
baseline assesment |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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)
|
15/06/2024 |
| 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="1"
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
|
Periodontal diseases are multi-agent infections caused by a number of anaerobic bacteria living on the tooth surface. Lipopolysaccharide and microbial agents in gingival tissues cause primary and permanent inflammation and subsequent increased levels of proinflammatory cytokine followed by the destruction of tooth supporting structures. Diabetes mellitus is a common metabolic disease characterized by hyperglycemia and impaired carbohydrate, protein, and lipid metabolism Moreover, numerous studies suggest that the risk of developing TYPE 2 diabetes mellitus is 5-15 times higher in prediabetic patients compared to in people with normal glucose levels. Prediabetes is defined as a disorder of altered glucose metabolism, which does not conclude the formal definition of diabetes but deliberates an increased risk of progression to diabetes and/or vascular disease. The objective of the study includes, to assess the periodontal status of prediabetic subjects, to assess the periodontal status of diabetic subjects, to assess the periodontal status of non-diabetic subjects and to compare the periodontal status between the groups. The study design is cross sectional study, it will be conducted at Department of Periodontology, Yenepoya dental college. Periodontal parameters will be measured from 48 subjects who volunteer to participate in the study. The data will be collected from the three different groups: Group1: Prediabetic, Group 2: Diabetic, Group 3: Non-diabetic. The following clinical parameters will be assessed: 1.Silness and Loe Plaque index (PI) 2. Loe and Silness Gingival Index (GI) 3. Probing depth 4.Clinical attachment level 5.Marginal bone loss. Descriptive measures like mean and standard deviation will be used to estimate the plaque index, gingival index and periodontal pocket depth. One way ANOVA will be used to test the difference. Karl pearson correlation coefficient will be used to estimate the correlation between them. |