REF/2013/10/005844
CTRI Website URL - http://ctri.nic.in
Clinical Trial Details (PDF Generation Date :- Sat, 01 Oct 2016 06:55:33 GMT)
CTRI Number
CTRI/2013/12/004249 [Registered on: 26/12/2013] - Trial Registered Retrospectively
Last Modified On
24/12/2013
Post Graduate Thesis Yes
Type of Trial
Observational
Type of Study
Cohort Study
Study Design
Single Arm Trial
Public Title of Study
COMPARISON OF ORAL HEALTH IN RENAL PATIENTS BEFORE AND AFTER RENAL
TRANSPLANTATION
Scientific Title of
Study
ASSESSMENT OF PERIODONTAL STATUS IN RENAL RECEIPIENTS BEFORE AND AFTER
TRANSPLANTATION -A COHORT STUDY
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal
Investigator or overall
Name
Trial Coordinator
Designation
(multi-center study)
Affiliation
Details of Principal Investigator
SHANILA K A
MDS STUDENT
GOVT DENTAL COLLEGE CALICUT
Address
DENTAL LADIES HOSTEL,MEDICAL COLLEGE P O,CALICUT
KERALA ROOM NO 38, DEPARTMENT OF PERIODONTICS,
GOVT. DENTAL COLLEGE CALICUT
Kozhikode
KERALA
673008
India
Phone
9495292506
Fax
Email
Details Contact
Person (Scientific
Query)
shanilaka5@gmail.com
Details Contact Person (Scientific Query)
Name
ROSAMMA JOSEPH V
Designation
PROFESSOR AND HOD
Affiliation
KERALA UNIVERSITY OF HEALTH SCIENCES
Address
ROOM NO 38, DEPARTMENT OF PERIODONTICS, GOVT.
DENTAL COLLEGE CALICUT
Kozhikode
KERALA
673008
India
Phone
9446070599
Fax
Email
Details Contact
Person (Public Query)
drrosammajoseph@gmail.com
Details Contact Person (Public Query)
Name
SHANILA K A
Designation
MDS STUDENT
Affiliation
GOVT DENTAL COLLEGE CALICUT
Address
DENTAL LADIES HOSTEL,MEDICAL COLLEGE P O,CALICUT
KERALA ROOM NO 38, DEPARTMENT OF PERIODONTICS,
GOVT. DENTAL COLLEGE CALICUT
Kozhikode
KERALA
673008
page 1 / 4
REF/2013/10/005844
CTRI Website URL - http://ctri.nic.in
India
Phone
9495292506
Fax
Email
Source of Monetary or
Material Support
shanilaka5@gmail.com
Source of Monetary or Material Support
> Govt Dental College Kozhikode
Primary Sponsor
Primary Sponsor Details
Name
SHANILA K A
Address
Dept of periodontics, Government dental college, Kozhikode
Type of Sponsor
Other [PERSONAL MONEY]
Details of Secondary
Sponsor
Name
Address
NIL
NIL
Countries of
Recruitment
List of Countries
Sites of Study
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Shanila K A
Government Dental
college and medical
college kozhikode
Department of
periodontics, Room no
:38, Third floor,
Government dental
college Kozhikode
KERALA
Kozhikode
KERALA
9495292506
Approval Status
Date of Approval
Is Independent Ethics
Committee?
Institutional ethics
Approved
committee, Government
dental college,
Kozhikode
13/02/2012
No
Regulatory Clearance
Status from DCGI
Status
Date
Not Applicable
No Date Specified
Health Condition /
Problems Studied
Health Type
Condition
Patients
end stage chronic kidney disease patients
Intervention /
Comparator Agent
Type
Details of Ethics
Committee
India
Name of Committee
Name
Inclusion Criteria
Exclusion Criteria
shanilaka5@gmail.com
Details
Inclusion Criteria
Age From
15.00 Year(s)
Age To
45.00 Year(s)
Gender
Both
Details
1. ESRD patients who are posted for renal transplantation
2. have a negative history of acute infections and no use of
antibiotics within past 4 months
3. No periodontal treatment within past 1 year
4. Absence of other systemic conditions that might directly affect
systemic inflammatory status, e.g., rheumatoid or autoimmune
diseases;
Exclusion Criteria
page 2 / 4
REF/2013/10/005844
CTRI Website URL - http://ctri.nic.in
Details
1. Subjects who were diagnosed with chronic kidney disease(stage I,
II, III, IV)
2. Patients with acute condition that contraindicated a periodontal
examination
3. Patients who received systemic antibiotic therapy within 6 months
4. Patients with psychiatric illness or mental retardation
5. Malignancies
Method of Generating Not Applicable
Random Sequence
Method of
Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
worsening of periodontal parameters
Secondary Outcome
Timepoints
six months after renal transplantation
Outcome
gingival overgrowth
Target Sample Size
Total Sample Size=30
Sample Size from India=30
Phase of Trial
N/A
Date of First
Enrollment (India)
07/03/2012
Date of First
Enrollment (Global)
No Date Specified
Timepoints
6 months
Estimated Duration of Years=1
Trial
Months=6
Days=1
Recruitment Status of Not Applicable
Trial (Global)
Recruitment Status of Completed
Trial (India)
Publication Details
Brief Summary
Chronic kidney disease is a generalized term for a variety of chronic conditions that result
in compromised renal functions with profound hydro electrolytic, metabolic, and
immunological imbalance. In order to support their life the patients need substitution of
the renal function either by means of dialysis or by renal transplant. Dental and
periodontal infection can jeopardize newly transplanted kidney. Periodontal pocket may
act as foci for infections. Recent report suggested that periodontal disease should be
viewed on the basis of the model of virus bacterial host immune interaction. Thus
periodontal pathogen can potentiate bacteremia/viremia in immunosuppressed patients.
High frequency of putative anaerobic pathogens in periodontal plaques and Human
cytomegalovirus (HCMV) might increase the chance of rejection of transplant
.Immunosuppressant therapy in renal receipient could also affect the oral and
periodontal health .The total health status and survivability after the transplantation
increase manifold if there exists a dental focal infection .
Very few studies reported oral health status in end stage renal disease
and renal transplant patients. Moreover, a comparison of oral health status between preand post renal transplant patients has not been described until the present.
AIM
page 3 / 4
REF/2013/10/005844
CTRI Website URL - http://ctri.nic.in
To assess the periodontal status before and after renal transplantation.
OBJECTIVES
To assess prevalence and incidence of periodontal disease and dental caries status
before and after
renal transplantation.
To assess the IgM (Human cytomegalo virus) level before and after renal transplantation.
To assess the presence of gingival overgrowth and oral mucosal lesions after renal
transplantation.
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