Periodontal Health and Its Impact on Oral Health-related Quality of Life Among Diabetes Mellitus Patients

Sponsor
Pakistan Institute of Medical Sciences (Other)
Overall Status
Recruiting
CT.gov ID
NCT06125561
Collaborator
(none)
80
1
1.2
64.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Probing depth and Clinical attachment loss

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 Design

Study Type:
Observational
Anticipated Enrollment :
80 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
A Study of Periodontal Health and Its Impact on Oral Health-related Quality of Life Among Diabetes Mellitus Patients
Actual Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Nov 8, 2023
Anticipated Study Completion Date :
Nov 8, 2023

Arms and Interventions

Arm 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.

Other: Probing depth and Clinical attachment loss
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.

Other: Probing depth and Clinical attachment loss
CPTIN probe will be used for the clinical examination

Outcome Measures

Primary Outcome Measures

  1. oral health-related quality of life [1 day]

    the impact of periodontal health on the oral health-related quality of life

Secondary Outcome Measures

  1. Clinical attachment loss [1 day]

    Probing depth and clinical attachment loss will be measured

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 PIMS Islamabad Pakistan

Sponsors and Collaborators

  • Pakistan Institute of Medical Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
nosheen sarwar, Principle Investigator, Pakistan Institute of Medical Sciences
ClinicalTrials.gov Identifier:
NCT06125561
Other Study ID Numbers:
  • 14112023
First Posted:
Nov 9, 2023
Last Update Posted:
Nov 9, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 9, 2023