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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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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