Patient ComplianceNCT05587413
Effectiveness of Periodontal Treatment for the Glycemic Conttrol of Type II Diabetes Mellitus
A study testing periodontal care in people with Patient Compliance, run by University of Lahore at 1 site in Pakistan.
Trial summary
The project is intended to find out the effect of Periodontal treatment for the glycemic control of type II diabetes mellitus patients. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Patient Compliance
- What is being tested?
- periodontal care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 sitePakistan
- Study dates
- 2 Nov 2022to 30 Dec 2022
- Phase
- Interventional
- 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 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients having Diabetes Mellitus and diagnosed with Periodontitis for last six months.
- Aged between 30-60 years.
- Patients with HbA1C level 7-9.5%, measured within three months prior to present study.
Who cannot join
- Patients with acute oral infection
- Need for immediate tooth extractions
- Severe Hypertension (>180/110 mm Hg)
- Edentulous Patients
- Patients with Diabetic Nephropathy
- Patients with Diabetic Retinopathy
Trial locations and contacts
1 site in 1 country.
About this study
The project is intended to find out the effect of Periodontal treatment for the glycemic control of type II diabetes mellitus patients.
- Conditions
- Patient Compliance
- Being tested
- periodontal care
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
periodontal careProcedure or surgery
periodontal treatment
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | Not described Receives: Procedure: periodontal care |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of HbA1C between the control group and interventional group.
The primary outcome of the trial
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start2 Nov 2022 (estimated)
- Primary completion20 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient ComplianceStudies of the same condition, open and under way.
- More trials run by University of LahoreThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gul Muhammad Shaikh, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05587413
- Sponsor's protocol ID
- UIPH/UOL/193/2019
- Status last verified
- Nov 2022
- First submitted
- 12 Oct 2022
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: will be informed
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Periodontal Treatment for the Glycemic Conttrol of Type II Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05587413
- Acronym / sponsor ID
- UIPH/UOL/193/2019
- Conditions
- Patient Compliance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 2 Nov 2022 (estimated)
- Primary completion
- 20 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 20 Oct 2022 (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.
The project is intended to find out the effect of Periodontal treatment for the glycemic control of type II diabetes mellitus patients.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Procedure: periodontal care |
| control group | No intervention | – |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients having Diabetes Mellitus and diagnosed with Periodontitis for last six months.
- Aged between 30-60 years.
- Patients with HbA1C level 7-9.5%, measured within three months prior to present study.
Key exclusion criteria (6 listed)
- Patients with acute oral infection
- Need for immediate tooth extractions
- Severe Hypertension (>180/110 mm Hg)
- Edentulous Patients
- Patients with Diabetic Nephropathy
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 careperiodontal treatment | Procedure or surgery | treatment group |
Primary outcome
Change of HbA1C between the control group and interventional group.
Time frame: one year
The primary outcome of the trial
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Individual participant dataSharing planned: Undecided. will be informed
Related trials for Patient Compliance
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Not yet recruiting
Testing a Smartphone App to Support a Mediterranean Diet and Strength Exercise
Treatment Adherence and Compliance, Resistance Exercise
Recruiting
Hybrid mHealth and Telerehabilitation vs Conventional Physiotherapy for Subacromial Pain Syndrome
Subacromial Pain Syndrome
Not yet recruiting
Use and Acceptability of an AI-Assisted Health Application for Individuals Living With a Chronic Condition
Hypertension, Diabetes Mellitus, Type 2
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing periodontal care in people with Patient Compliance, run by University of Lahore 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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 2 Nov 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact gul muhammad shaikh, bds (923332663614, shaikhgul25@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of HbA1C between the control group and interventional group. (time frame: one year). 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 2 Nov 2022.