| CTRI Number |
CTRI/2017/11/010333 [Registered on: 01/11/2017] Trial Registered Retrospectively |
| Last Modified On: |
31/10/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Assessment of salivary Lactoferrin protein in patients with Gum diseases having Diabetes mellitus. |
|
Scientific Title of Study
|
Estimation of Salivary Lactoferrin in Chronic Periodontitis Associated with Type -2 Diabetes Mellitus. 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 |
Anusha Dayyala |
| Designation |
Post Graduate Student |
| Affiliation |
Narayana Dental College |
| Address |
Department of Periodontics,Narayana Dental College and Hospital, Chintareddypalem, Nellore.
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
8074346512 |
| Fax |
|
| Email |
akshayapriya89@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
BV Ramesh Reddy |
| Designation |
Professor |
| Affiliation |
Narayana Dental College |
| Address |
Narayana Dental College and Hospital
Chintareddypalem
Nellore
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
8074346512 |
| Fax |
|
| Email |
perioramesh@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Anusha Dayyala |
| Designation |
Post Graduate Student |
| Affiliation |
Narayana Dental College |
| Address |
Narayana Dental College and Hospital
Chintareddypalem
Nellore
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
8074346512 |
| Fax |
|
| Email |
akshayapriya89@gmail.com |
|
|
Source of Monetary or Material Support
|
| D Anusha
Department of Periodontics
Narayana Dental College
Nellore |
| D Anusha |
|
|
Primary Sponsor
|
| Name |
D Anusha |
| Address |
Department of Periodontics
Narayana Dental College
Chintareddypalem
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 |
| D Anusha |
Narayana Dental College |
Narayana dental College and Hospital
Department of periodontics
Chintareddypalem
Nellore
Nellore
ANDHRA PRADESH |
8074346512
akshayapriya89@gmail.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 |
| Patients |
Diabetes and Chronic Generalised Periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
D Anusha |
Lactoferrin in saliva of Chronic generalized periodontitis associated with type -2 Diabetes mellitus |
| Intervention |
D Anusha |
Nil |
| Comparator Agent |
D Anusha |
Nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1)Age greater than 30yrs
2)greater than 20 teeth present
3)greater than 10% of teeth with probing depth of greater than or equal to 4mm
4)Bleeding on probing
|
|
| ExclusionCriteria |
| Details |
1)No other systemic disease apart from diabetes
2)Smokers
3)Patients who had received periodontal therapy with in 6months before study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Plaque Index,Modified Sulcular Bleeding Index, Probing Depth, Clinical Attachment Loss. |
Baseline and 1 month after Phase - I Periodontal Therapy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="51"
Sample Size from India="51"
Final Enrollment numbers achieved (Total)= "51"
Final Enrollment numbers achieved (India)="51" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/02/2016 |
| Date of Study Completion (India) |
30/10/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
All the patients were explained about the aim, nature and design of the study along with a written Informed Consent for their participation before the Commencement of the study. A Clinico- Biochemical Study was Conducted by the Department of Periodontology, Narayana Dental College and Hospital, Nellore,Andhra Pradesh, India. To correlate the Salivary Lactoferrin levels in Diabetes Mellitus and chronic Periodontitis before and after Periodontal Phase- I Treatment. Patients with age limit 30-50 years will be selected from the out patient Department of Periodontology. Subjects were divided into 3 groups.Group-1 periodontally healthy subjects, Group-2 chronic periodontitis patients, Group-3 chronic periodontitis with diabetes mellitus patients.clinical parameters such as plaque index, bleeding index, probing depth, clinical attachment levels are recorded using periodontal probe before saliva sample collection.Unstimulated saliva was collected from the three groups and will be subjected to analysis of Lactoferrin levels. Group- 2 and Group-3 are subjected to phase I periodontal treatment and recordings are performed at baseline and after 4 weeks. values recorded are subjected for statistical analysis. Results are yet to come.
|