| CTRI Number |
CTRI/2024/06/068417 [Registered on: 06/06/2024] Trial Registered Prospectively |
| Last Modified On: |
04/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Factors Causing Delay in Treatment Seeking for Common Oral Diseases among Geriatric Population |
|
Scientific Title of Study
|
Late Stage Presentation and Associated Factors of Common Oral Diseases among Geriatric Population Reporting at a Tertiary Care Institution |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dimla Denny C |
| Designation |
Assistant Professor |
| Affiliation |
Kannur Dental College |
| Address |
Department of Oral Medicine and Radiology, Kannur Dental College, Anjarakandy, Kannur, Kerala.
Kannur KERALA 670105 India |
| Phone |
9495854948 |
| Fax |
|
| Email |
dimlaphinse@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Athirarani M R |
| Designation |
Associate Professor |
| Affiliation |
Govt. College of Nursing |
| Address |
Department of Community Health Nursing, Govt. College of Nursing, Thiruvananthapuram - 695 011, Kerala, India
Thiruvananthapuram KERALA 695011 India |
| Phone |
9446536435 |
| Fax |
|
| Email |
athiraaparna@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dimla Denny C |
| Designation |
Assistant Professor |
| Affiliation |
Kannur Dental College |
| Address |
Department of Oral Medicine and Radiology, Kannur Dental College, Anjarakandy, Kannur, Kerala.
Kannur KERALA 670105 India |
| Phone |
9495854948 |
| Fax |
|
| Email |
dimlaphinse@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kannur Dental College, Anjarakandy, Anjarakandy Integrated Campus, Anjarakandy (PO), Kannur, Kerala. Pin Code- 670612 |
|
|
Primary Sponsor
|
| Name |
Dimla Denny C |
| Address |
Assistant Professor
Dept of Oral Medicine and Radiology, Kannur Dental College, Anjarakandy, Anjarakandy Integrated Campus, Anjarakandy (PO), Kannur, Kerala. Pin Code- 670612
Kannur Dental College
Anjarakandy, Kannur,Kerala. |
| 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 |
| Dr Dimla Denny C |
Kannur Dental College, Anjarakandy |
Department of Oral Medicine and Radiology, Room No. 1, Ground Floor, Anjarakandy, Anjarakandy Integrated Campus, Anjarakandy (PO), Kannur, Kerala. Pin Code- 670612 Kannur KERALA |
9495854948
dimlaphinse@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Kannur Dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, (2) ICD-10 Condition: K081||Complete loss of teeth, (3) ICD-10 Condition: K029||Dental caries, unspecified, (4) ICD-10 Condition: K060||Gingival recession, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Newly registered Patients at Dental OPD of age 60 years and above, presenting with complaint related to Common Oral Diseases (Dental Caries, Periodontitis or Edentulism),
Patients who were referred to the dental OPD for the management of Common Oral Diseases
|
|
| ExclusionCriteria |
| Details |
Patients with co-existing psychiatric illness, Critically ill patients
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The proportion of geriatric patients presenting with late stages of caries of permanent teeth, periodontitis or edentulism |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Various factors associated with Late- Stage presentation of Common Oral Diseases among Geriatric Patients |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="369" Sample Size from India="369"
Final Enrollment numbers achieved (Total)= "369"
Final Enrollment numbers achieved (India)="369" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/06/2024 |
| Date of Study Completion (India) |
20/09/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="3" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Most
of the oral diseases are preventable and disease progression can be prevented
by simpler interventions. Despite of this, they are very common in our
population and geriatric age group gets affected the most. Oral
diseases presented at late stage will have poor prognosis and it will affect
the patient’s quality of life. There is no data available
on late stage presentation of common oral diseases and associated factors. No studies
from India has been noticed in the literature. Therefore the present research proposal aims to identify the proportion of Geriatric patients
presenting with Late Stage of Common Oral Diseases in a Tertiary care
institution of Northern Kerala and the factors associated. The study is designed as a Hospital-based Cross-sectional study and the setting will be the Out patient
Department of a Tertiary care institution. The study population will be geriatric
patients aged 60 and above. The sample size was calculated as 369. The inclusion criteria are Newly
registered Patients at Dental OPD of age 60 years and above, presenting with complaint
related to Common Oral Diseases (Dental Caries, Periodontitis or Edentulism) and Patients who were referred to the dental
OPD for the management of Common Oral Diseases. The exclusion criterias include Patients
with co-existing psychiatric illness and Critically ill patients. The case definitions (ICD-10) are K02.1 (Caries of Dentine), K02.3 (Arrested Dental Caries), K02.5 (Caries with Pulp exposure), K02.8 ( Other dental caries), K02.9 (Dental Caries, unspecified), K05.3 (Chronic Periodontitis) & K06.0
– Gingival Recession with Clinical Attachment Loss more than 6 mm and K08.0 (Exfoliation of teeth due to
systemic causes) & K08.1 (Loss of teeth due to accident, extraction or
local periodontal disease) with less than 9 remaining teeth. The Late
stage presentation will be categorized according to the following criteria: Severe Dental Caries - Measured
by Visual and Tactile examination and assessed by Caries Assessment Spectrum
Treatment (CAST) Severity Score. Score more than 16 will be classified as
Severe level of Disease, Severe Periodontitis - Two or more interproximal sites with Clinical
Attachment Loss (CAL) ≥ 6 mm, not on the same tooth, and one or more
interproximal sites with Probing Depth (PD) ≥ 5 mm [5] (CDC working group definition for use
in population surveillance of Periodontitis and Severe Edentulism - Fewer than nine
teeth are remaining in the mouth (WHO, Global Burden of Disease). Data collection will be done by interviewer administerd questionnaire and clinical examination. Analysis will be done by univariate , bivariate and multivariate analysis techniques. Ethical aspects of the research - Approval
from the Scientific Research Committee(SRCKDC) and Institutional Ethical Committee
of Kannur Dental College, Anjarakandy (IECKDC) has been obtained. An informed consent will be obtained from the
participant after explaining the details of the study. A participant information sheet will be provided. Only the Principal Investigator will have access to
the collected data. We will maintain the confidentiality of the data in
every step of the study. The expected outcome- The
proposed research will explore the proportion of geriatric patients presented
in the late stage of Common Oral Diseases like Severe Caries of Permanent Teeth,
Severe Periodontitis and Severe Edentulism. The research will also provide an
idea about various factors affecting Late Stage presentation of these Common
Oral Diseases. Policy
Implications - The study results will help to
identify the severity and contributing factors of late stage presentation of
common oral diseases in the vulnerable geriatric population. This will help
policy makers to give due importance to oral healthcare while planning
geriatric healthcare programmes.
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