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Status unknownNCT06125561Updated Nov 9, 2023

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

An observational study in Diabetes Mellitus and Periodontal Diseases, sponsored by Pakistan Institute of Medical Sciences. Status unknown at 1 site in Pakistan. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-11-09.

Sponsored by Pakistan Institute of Medical Sciences · Observational

The sponsor has not verified this record recently (last verified Nov 2023), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
80
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Diabetes Mellitus
  • Periodontal Diseases
03

In context

Diabetes Mellitus

11,089 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's planned enrollment of 80 is below the median of 234 across 2,254 observational studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Pakistan Institute of Medical Sciences is the lead sponsor of 54 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The patient presented at dental department of hospital

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
80 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • 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

Interventions

  • OtherProbing depth and Clinical attachment loss

    CPTIN probe will be used for the clinical examination

06

What researchers measure

Primary outcomes

  1. oral health-related quality of life

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

    Time frame: 1 day

Secondary outcomes

  1. Clinical attachment loss

    Probing depth and clinical attachment loss will be measured

    Time frame: 1 day

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2023 (actual). Primary completion is estimated for Nov 2023, 1 month after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 4, 2023
First posted
Nov 9, 2023
StartActual
Oct 1, 2023
Primary completionEst.
Nov 8, 2023
CompletionEst.
Nov 8, 2023
Last update
Nov 9, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 9, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06125561
Lead sponsor
Pakistan Institute of Medical Sciences
Responsible party
nosheen sarwar (Principle Investigator, Pakistan Institute of Medical Sciences) — Principal investigator
First posted
Nov 9, 2023
Start date
Oct 1, 2023
Primary completion
Nov 8, 2023 (estimated)
Completion
Nov 8, 2023 (estimated)
Last update
Nov 9, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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