| CTRI Number |
CTRI/2018/11/016360 [Registered on: 15/11/2018] Trial Registered Retrospectively |
| Last Modified On: |
13/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Indicators of Gum Diseases |
|
Scientific Title of Study
|
Comparative evaluation of Gingival Crevicular Fluid haem and microbial composition in smokers and non-smokers with chronic localized periodontitis- A Clinicomicrobiologial study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shobha Krishna Subbaiah |
| Designation |
READER |
| Affiliation |
THE OXFORD DENTAL COLLEGE AND HOSPITAL |
| Address |
Department of Periodontics, The Oxford Dental College Bommanahalli, Hosur road, Bangalore.
The Oxford Dental College Bommanahalli, Hosur road,Bangalore
Bangalore
KARNATAKA
560068
India |
| Phone |
09743414604 |
| Fax |
080-30410569 |
| Email |
shobhasubbaiah@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shobha Krishna Subbaiah |
| Designation |
READER |
| Affiliation |
THE OXFORD DENTAL COLLEGE AND HOSPITAL |
| Address |
Department of Periodontics,
The Oxford Dental College Bommanahalli, Hosur road, Bangalore.
The Oxford Dental College Bommanahalli, Hosur road, Bangalore.
Bangalore
KARNATAKA
560068
India |
| Phone |
09743414604 |
| Fax |
080-30410569 |
| Email |
shobhasubbaiah@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shobha Krishna Subbaiah |
| Designation |
READER |
| Affiliation |
THE OXFORD DENTAL COLLEGE AND HOSPITAL |
| Address |
Department of Periodontics,
The Oxford Dental College Bommanahalli, Hosur road, Bangalore
The Oxford Dental College Bommanahalli, Hosur road, Bangalore
Bangalore
KARNATAKA
560068
India |
| Phone |
09743414604 |
| Fax |
080-30410569 |
| Email |
shobhasubbaiah@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajiv Gandhi university of health sciences 4th T block Jayanagar Bangalore 560041
|
|
|
Primary Sponsor
|
| Name |
Rajiv Gandhi University of Health Sciences Karnataka |
| Address |
Rajiv Gandhi University of Health Sciences, Karnataka, 4th T Block, Jayanagar, bangalore-560041 |
| Type of Sponsor |
Government funding agency |
|
|
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 Shobha Krishna Subbaiah |
The Oxford dental college and hospital, Bangalore. |
The Oxford Dental College and Hospital Bommanahalli Electronic city main road
Bangalore
KARNATAKA |
09743414604
shobhasubbaiah@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IECTODC |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
GCF free haem concentration and subgingival microbial composiiton is compared at periodontally healthy and diseased sites in smokers and non-smokers |
GCF free haem and subgingival microbial composition is correlated with periodontal clinical paramenters and to note if any difference is there between smokers and non-smokers |
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Systemically healthy individuals aged between 20-50 years
2. Subjects with at least 20 teeth and 2 non-adjacent probing pocket depth ≥ 5mm and CAL ≥ 3mm per quadrant with radiographic bone loss >20%.
3. Current smokers i.e. persons who have smoked 100 cigarettes and who currently smoke every day or someday will be selected (smokers group)6
|
|
| ExclusionCriteria |
| Details |
1. Medically compromised patients or any systemic illness which can influence the haemoglobin level of the subject.
2. Pregnant/lactating women
3. Subjects who have taken antibiotics before the initiation of study
4. Subjects with a history of periodontal treatment in the last 6 months
5. Subjects with symptoms of acute illness, orthodontic appliances or presence of oral mucosal inflammatory conditions or salivary gland dysfunction
|
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Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Initiation and progression of periodontal diseases is the result of a complex interaction between the bacteria colonizing the gingival crevice and the innate and inflammatory responses of the host.this study aims to closely investigate the relationship between GCF free haem concentration, subgingival microbial composition and periodontal clinical parameters in smokers and non-smokers and find out if GCF free haem could be used as a biomarker for periodontal diseases. |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| This will help us in identifying susceptible patients in large populations very easily and quickly as it is a chair side diagnostic test. It will also help us to identify active diseased sites, predict sites vulnerable for future breakdown and serve as surrogate end points for monitoring the effectiveness of therapy which may not be possible with conventional diagnostic aids |
2 points |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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)
|
07/05/2018 |
| 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="6"
Days="25" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
1. Bodet C, Chandad F, Grenier D. Haemoglobin and LPS act in synergy to amplify the inflammatory response. J Dent Res 2007; 86(9):878-882,.
2. Richter HJ et al. Hemoglobin Enhances the Biological Activity of Synthetic and Natural Bacterial (Endotoxic) Virulence Factors: A General Principle. Medicinal Chemistry 2008;4(6):520-525.
3. Liu LY, McGregor N, Wong BKJ, Butt H, Darby IB.The association between clinical parameters and free haem concentration within the gingival crevicular field: a pilot study. J Periodont Res 2016;51:86-94.
4. MaFaul SJ, Bowman PD, Villa VM. Hemoglobin stimulates the release of proinflammatory cytokines from leukocytes in whole blood. J Lab Clin Med 2000;135:263-269.
5. Behl N et al. Delineation of lipopolysaccharide (LPS)-binding sites on hemoglobin. Journal of Biological Chemistry 2011;286(43):37793-37803.
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
study aims to investigate the level of local free haem in GCF at periodontally healthy sites compared with diseased sites in relation to clinical parameters and also to determine any correlation between smoking and haem concentrations at healthy and diseased sites. From a total of 74 subjects GCF and subgingival plaque samples will be collected from healthy and diseased sites in both smokers and non-smokers. |