- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06125561
Periodontal Health and Its Impact on Oral Health-related Quality of Life Among Diabetes Mellitus Patients
November 4, 2023 updated by: nosheen sarwar, Pakistan Institute of Medical Sciences
A Study of Periodontal Health and Its Impact on Oral Health-related Quality of Life Among Diabetes Mellitus Patients
Periodontal diseases, encompassing a range of inflammatory conditions affecting the supporting structures of the teeth, have long been recognized as a prevalent comorbidity in individuals with diabetes.
The severity of periodontal disease is usually documented by research clinicians using clinical parameters such as bleeding on probing (BOP), probing pocket depth (PPD), and clinical.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Oral health plays a pivotal role in the overall well-being and quality of life of individuals.
Any condition affecting oral health can have far-reaching consequences for an individual's daily life.Both periodontitis and diabetes have been reported to have negative impacts on aspects of daily living and health-related quality of life.
Evidence suggests that oral health problems can adversely affect an individual's physical functioning, social standing and wellbeing, and that it can be difficult to dissociate oral health from general health with regards to impacts on quality of life.
Oral health-related quality of life (OHRQoL) can be assessed using the Oral Health Impact Profile-14 (OHIP-14) questionnaire
Study Type
Observational
Enrollment (Estimated)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Islamabad, Pakistan
- Recruiting
- PIMS
-
Contact:
- Nosheen sarwar, BDS
- Phone Number: 03088895652
- Email: nosheensarwar18@gmail.com
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
The patient presented at dental department of hospital
Description
Inclusion Criteria:
- Individuals diagnosed with Diabetes Mellitus for case group, non diabetic patients for control group, Age range between 18 to 60 years, informed consent, Participants with varying degrees of periodontal health
Exclusion Criteria:
- Participants with severe systemic illnesses and habits that may significantly affect oral health or quality of life, Individuals with severe cognitive impairment or psychiatric conditions that hinder their ability to participate and provide informed consent.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Diabetic
Diabetic patients with age ranges 18-60 years.
Clinical Examination will be performed by CPTIN probe and questionnaire will be filled by participant's.
|
CPTIN probe will be used for the clinical examination
|
Non diabetic
Non Diabetic patients with age ranges 18-60 years.
Clinical Examination will be performed by CPTIN probe and questionnaire will be filled by participant's.
|
CPTIN probe will be used for the clinical examination
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
oral health-related quality of life
Time Frame: 1 day
|
the impact of periodontal health on the oral health-related quality of life
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical attachment loss
Time Frame: 1 day
|
Probing depth and clinical attachment loss will be measured
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2023
Primary Completion (Estimated)
November 8, 2023
Study Completion (Estimated)
November 8, 2023
Study Registration Dates
First Submitted
November 4, 2023
First Submitted That Met QC Criteria
November 4, 2023
First Posted (Estimated)
November 9, 2023
Study Record Updates
Last Update Posted (Estimated)
November 9, 2023
Last Update Submitted That Met QC Criteria
November 4, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14112023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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-
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