| CTRI Number |
CTRI/2021/10/037617 [Registered on: 27/10/2021] Trial Registered Prospectively |
| Last Modified On: |
12/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Salivary protiens and periodontitis |
|
Scientific Title of Study
|
Evaluation of salivary glycoconjugate levels in chronic periodontitis patients with and without diabetes mellitus type 2:A clinico-biochemical study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Valluru Sowmya |
| Designation |
Post graduate student |
| Affiliation |
Narayana dental college and hospital |
| Address |
Department of Periodontics, Room no. 5, Narayana dental college and hospital, Chinthareddypalem, Nellore
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9494189036 |
| Fax |
08612305092 |
| Email |
sowmyavalluru58@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrVijay kumar Chava |
| Designation |
Professor & HOD |
| Affiliation |
Narayana dental college and hospital |
| Address |
Department of Periodontics
Room No.5
Narayana dental college and hospital, Chinthareddypalem, Nellore
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9441978737 |
| Fax |
08612305092 |
| Email |
chava7@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijay kumar Chava |
| Designation |
Professor & HOD |
| Affiliation |
Narayana dental college and hospital |
| Address |
Department of periodontics, Room no. 5,Narayana dental college and hospital, Chinthareddypalem, Nellore
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9441978737 |
| Fax |
08612305092 |
| Email |
chava7@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Narayana dental college and hospital |
|
|
Primary Sponsor
|
| Name |
Self |
| Address |
Department of Periodontics, Narayana dental college and hospital, chinthareddypalem, nellore |
| 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 |
| DrVijaykumar Chava |
Room No.5, Department of Periodontics, Narayana Dental College & Hospital |
Chinthareddypalem
Nellore
ANDHRA PRADESH |
9441978737
chava7@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
non covid |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
33.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1 probing depth more than or equal to 5mm, 2 subjects with no periodontal treatment for the past 6 months, 3 oral glucose tolerance tests more than or equal to 200 mg per dl, or fasting plasma glucose more than or equal to 126 mg per dl or glycated Hb more than or equal to 6.5 |
|
| ExclusionCriteria |
| Details |
pregnant women, smokers, cardiovascular disease, immunodeficiency disorders, hemodialysis patients, bleeding disorders, rheumatoid arthritis, oral cancerous lesions |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to evaluate glycoconjugate levels in chronic periodontitis associated with diabetes mellits type 2. |
baseline 0 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| comparing protein bound and free sialic acid levels and total protein with and without diabetes mellitus type 2 |
baseline 0 |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
Final Enrollment numbers achieved (Total)= "92"
Final Enrollment numbers achieved (India)="92" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/11/2021 |
| Date of Study Completion (India) |
20/08/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Inflammation is the central feature of diabetes mellitus and periodontitis.The aim of the study is to evaluate the glycoconjugate levels ( free sialic acid and total protein) in the saliva of chronic periodontitis with and without diabetes mellitus type 2. The study evaluates, free sialic acid, protein-bound sialic acid, and total protein.
|