GingivitisNCT05101434
Gingivitis and Periodontitis as a Risk Factor for Stroke
An observational study of Gingivitis and Periodontitis, run by Shaheed Zulfiqar Ali Bhutto Medical University at 1 site in Pakistan.
Trial summary
Periodontitis and gingivitis are one of the most infectious diseases in humans. Several studies have been carried out on the dependence of periodontitis and stroke. The aim of this study was to investigate gingivitis and periodontitis as risk factors for stroke in the Pakistani population. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gingivitis, Periodontitis, Stroke
- What is being tested?
- Periodontal Probing
- Type of treatment
- Pill or oral medicine
- How many people
- 120 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Jan 2021to 20 Jul 2021
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All the patients with stroke (both ischemic and hemorrhagic)
Who may be able to join
- Diagnosed stroke by using brain imaging from magnetic resonance imaging and/or computerized tomography.
Who cannot join
- Not willing to participate
- Neurological complications other than stroke
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Shaheed Zulfiqar Ali Bhutto Medical University
Islamabad, Capital, 44000
About this study
Periodontitis and gingivitis are one of the most infectious diseases in humans. Several studies have been carried out on the dependence of periodontitis and stroke. The aim of this study was to investigate gingivitis and periodontitis as risk factors for stroke in the Pakistani population.
Read the detailed description
Epidemiologic studies have shown that cerebrovascular accident (CVA) is the 3rd cause of death in developed countries with 0.8 % prevalence in the whole population. Although, the prevalence rate of stroke is reduced yet is one of the most important health problems in the United State. Periodontitis and gingivitis are the two most infectious man diseases. Today, it is estimated that about 35% of people over 30-year-old in America and 50-55% of people in developing countries are involved with these diseases.
These diseases are due to the practice of chronic bacterial infection and the inflammatory response of the host. The relationship between periodontitis and CVA was first introduced by Mackenzi and Millard in 1963 but the importance of this issue was not understood. Periodontal infection can be a complex multiphase disease by associating this infection with organ systems such as cardiovascular, endocrine, reproductive, and respiratory systems. Nowadays, periodontitis is considered a risk factor for atherosclerosis and thromboembolic disease.
- Conditions
- Gingivitis, Periodontitis, Stroke
- Being tested
- Periodontal Probing
- Medical subject headings
- Gingivitis, Periodontitis, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal ProbingDiagnostic test
Also called ROAG revised oral assessment guide, Community periodontal index, Gingival Index
with the help Michigan probe, periodontal pocket measurement was done.
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingivitis
Measurement of bleeding site while probing and this was done with gingival index
Measured: baseline
Periodonitis
Measurement of periodontal pockets while probing and this was done with community periodontal idex
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2021
- Study start10 Jan 2021
- Primary completion10 Jul 2021
- Study completion20 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Shaheed Zulfiqar Ali Bhutto Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Hassan, Shaheed Zulfiqar Ali Bhutto Medical University
- Investigators
- Muhammad Hassan, MD, Principal investigator, Shaheed Zulfiqar Ali Bhutto Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05101434
- Sponsor's protocol ID
- Gingivitis and Stroke
- Status last verified
- Oct 2021
- First submitted
- 18 Oct 2021
- Last updated
- 1 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be shared on reasonable demand
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gingivitis and Periodontitis as a Risk Factor for Stroke
- ClinicalTrials.gov ID
- NCT05101434
- Acronym / sponsor ID
- Gingivitis and Stroke
- Conditions
- Gingivitis, Periodontitis, Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Shaheed Zulfiqar Ali Bhutto Medical UniversityUniversity, hospital or other
- Study start
- 10 Jan 2021 (actual)
- Primary completion
- 10 Jul 2021 (actual)
- Study completion
- 20 Jul 2021 (actual)
- First posted
- 1 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Periodontitis and gingivitis are one of the most infectious diseases in humans. Several studies have been carried out on the dependence of periodontitis and stroke. The aim of this study was to investigate gingivitis and periodontitis as risk factors for stroke in the Pakistani population.
Detailed description
Epidemiologic studies have shown that cerebrovascular accident (CVA) is the 3rd cause of death in developed countries with 0.8 % prevalence in the whole population. Although, the prevalence rate of stroke is reduced yet is one of the most important health problems in the United State. Periodontitis and gingivitis are the two most infectious man diseases. Today, it is estimated that about 35% of people over 30-year-old in America and 50-55% of people in developing countries are involved with these diseases.
These diseases are due to the practice of chronic bacterial infection and the inflammatory response of the host. The relationship between periodontitis and CVA was first introduced by Mackenzi and Millard in 1963 but the importance of this issue was not understood. Periodontal infection can be a complex multiphase disease by associating this infection with organ systems such as cardiovascular, endocrine, reproductive, and respiratory systems. Nowadays, periodontitis is considered a risk factor for atherosclerosis and thromboembolic disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All the patients with stroke (both ischemic and hemorrhagic)
Key inclusion criteria (1 listed)
- Diagnosed stroke by using brain imaging from magnetic resonance imaging and/or computerized tomography.
Key exclusion criteria (2 listed)
- Not willing to participate
- Neurological complications other than stroke
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Periodontal ProbingAlso: ROAG revised oral assessment guide, Community periodontal index, Gingival Indexwith the help Michigan probe, periodontal pocket measurement was done. | Diagnostic test | – |
Primary outcome
Gingivitis
Time frame: baseline
Measurement of bleeding site while probing and this was done with gingival index
Periodonitis
Time frame: baseline
Measurement of periodontal pockets while probing and this was done with community periodontal idex
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
- Individual participant dataSharing planned: Undecided. Data will be shared on reasonable demand
Related trials for Gingivitis
Not yet recruitingPhase 3
Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
Preterm Birth, Low Birth Weight
Not yet recruitingPhase 2
Efficacy of Thymus Vulgaris Mouthwash in the Management of Biofilm-Induced Gingivitis
Plaque-Induced Gingivitis
Not yet recruiting
Effectiveness of Oil Pulling Using Oils in Comparison With Mouthwash for Gingivitis
Gingivitis
Not yet recruitingObservational study
Circadian Clock Proteins in Gingival Crevicular Fluid of Individuals With and Without Circadian Rhythm Disruption
Gingivitis, Circadian Rhythm Disruption
Active, not recruitingObservational study
Comparison of Saliva Characteristics and Oral Health in Pregnant and Non-pregnant Women
Plaque Induced Gingivitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Hassan, MD principal investigator
Shaheed Zulfiqar Ali Bhutto Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gingivitis and Periodontitis, run by Shaheed Zulfiqar Ali Bhutto Medical University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gingivitis (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2021.