Diabetes Mellitus Type 2NCT01901926
Periodontal Treatment and Glycemic Control
A study testing Non Surgical Periodontal Treatment in people with Diabetes Mellitus Type 2, run by Pakistan Institute of Medical Sciences at 1 site in Pakistan.
Trial summary
The purpose of this study is to determine the effects of non surgical periodontal treatment on glycemic control in type II diabetics. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- Non Surgical Periodontal Treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 sitePakistan
- Study dates
- Dec 2012to Oct 2013
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed patients of Type 2 Diabetes Mellitus for at least 2 years
- HbA1C values >6.5 % as per ADA criteria
- non smokers
- Patients with at least 16 standing teeth
- At least 8 teeth with one site having Mild to Moderate periodontal disease
Who cannot join
- Smokers
- Type 2 Diabetics with complications e.g. renal, ophthalmic etc
- Patients with chronic infections
- Patients who get hospitalized or have to change their medications during the course of study
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Pakistan Institute of Medical Sciences
Islamabad, Federal Capital, 54000
About this study
Official title: Impact of Non Surgical Periodontal Treatment on Glycemic Control in Type II Diabetics
The purpose of this study is to determine the effects of non surgical periodontal treatment on glycemic control in type II diabetics.
Read the detailed description
The selected patients in treatment group will be given mechanical periodontal treatment in the form of scaling and root planning while the non intervention group patients will not receive treatment until the end of the trial.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- Non Surgical Periodontal Treatment
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non Surgical Periodontal TreatmentProcedure or surgery
one time intervention in the form of scaling and root planing
| Study group | Role | What they receive |
|---|---|---|
| Periodontal Treatment | Active comparator | Periodontal Treatment in the form of Full mouth scaling and root planning will be given at one time only i.e. at baseline after full mouth dental checkup.
Checkup will be repeated at 3, 6 \& 9 month interval along with HbA1C levels Receives: Procedure: Non Surgical Periodontal Treatment |
| Non treatment group | No intervention | this group will only receive detailed dental check ups at the specified time 0, 3, 6 and 9 months respectively and there will be no scaling done. HbA1C levels will be estimated at the above specified times |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1C levels from base line at 3, 6 and 9 months
HbA1C levels will be recorded and any change in percentage noted
Measured: 3 months, 6 months, 9 months
Secondary outcomes (3)
Bleeding on Probing
a change in the above mentioned periodontal parameters will be recorded at the specified times Bleeding on probing will be recorded as Yes or No for each tooth
Measured: Base Line, 3 months, 6 months and 9 months
Clinical Attachment Loss
A change in the above mentioned periodontal parameter will be recorded at the specified times Clinical Attachment loss will be recorded in millimeters for each tooth
Measured: Base Line, 3 months, 6 months, 9 months
Periodontal Pocket Depth
A change in Periodontal pocket will be measured in millimeters for the above mentioned time frame
Measured: Base Line, 3 months, 6 months, 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2013 (estimated)
- Study startDec 2012
- Primary completionSep 2013 (estimated)
- Study completionOct 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 2Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Medical Sciences
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Salman Aziz, Pakistan Institute of Medical Sciences
- Investigators
- Salman Aziz, FCPS, MFDS, Principal investigator, Pakistan Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01901926
- Sponsor's protocol ID
- Salman-0509
- Status last verified
- Jul 2013
- First submitted
- 12 Jun 2013
- Last updated
- 17 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Non Surgical Periodontal Treatment on Glycemic Control in Type II Diabetics
- ClinicalTrials.gov ID
- NCT01901926
- Acronym / sponsor ID
- Salman-0509
- Conditions
- Diabetes Mellitus Type 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Pakistan Institute of Medical SciencesOther government
- Study start
- Dec 2012
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Oct 2013 (estimated)
- First posted
- 17 Jul 2013 (estimated)
- 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 purpose of this study is to determine the effects of non surgical periodontal treatment on glycemic control in type II diabetics.
Detailed description
The selected patients in treatment group will be given mechanical periodontal treatment in the form of scaling and root planning while the non intervention group patients will not receive treatment until the end of the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Periodontal Treatment | Active comparator | Procedure: Non Surgical Periodontal TreatmentPeriodontal Treatment in the form of Full mouth scaling and root planning will be given at one time only i.e. at baseline after full mouth dental checkup. Checkup will be repeated at 3, 6 \& 9 month interval along with HbA1C levels |
| Non treatment group | No intervention | –this group will only receive detailed dental check ups at the specified time 0, 3, 6 and 9 months respectively and there will be no scaling done. HbA1C levels will be estimated at the above specified times |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed patients of Type 2 Diabetes Mellitus for at least 2 years
- HbA1C values >6.5 % as per ADA criteria
- non smokers
- Patients with at least 16 standing teeth
- At least 8 teeth with one site having Mild to Moderate periodontal disease
Key exclusion criteria (4 listed)
- Smokers
- Type 2 Diabetics with complications e.g. renal, ophthalmic etc
- Patients with chronic infections
- Patients who get hospitalized or have to change their medications during the course of study
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 |
|---|---|---|
| Non Surgical Periodontal Treatmentone time intervention in the form of scaling and root planing | Procedure or surgery | Periodontal Treatment |
Primary outcome
Change in HbA1C levels from base line at 3, 6 and 9 months
Time frame: 3 months, 6 months, 9 months
HbA1C levels will be recorded and any change in percentage noted
3 secondary outcomes
Bleeding on Probing
Time frame: Base Line, 3 months, 6 months and 9 months
Clinical Attachment Loss
Time frame: Base Line, 3 months, 6 months, 9 months
Periodontal Pocket Depth
Time frame: Base Line, 3 months, 6 months, 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2013.
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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.
Salman Aziz, FCPS, MFDS principal investigator
Pakistan Institute of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non Surgical Periodontal Treatment in people with Diabetes Mellitus Type 2, run by Pakistan Institute of Medical Sciences 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 5 inclusion and 4 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 17 Jul 2013. 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?
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?
Change in HbA1C levels from base line at 3, 6 and 9 months (time frame: 3 months, 6 months, 9 months). 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 17 Jul 2013.