PeriodontitisPARODIA2NCT02830113
Metabolic Effects of Treatment of Chronic Periodontitis in Non-diabetic Subjects
A study testing non-surgical periodontal treatment in people with Periodontitis and Prediabetes, run by Yaounde Central Hospital.
Trial summary
This study was aimed at assessing the effects of non-surgical periodontal treatment (NSPT) of chronic periodontitis on insulin sensitivity, glucose tolerance, and serum C-reactive protein(CRP) level amongst non-diabetic subjects. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Prediabetes
- 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
- 20 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Sep 2015
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Chronic periodontitis
- Non diabetic individual
Who cannot join
- Known diabetes
- Periodontal treatment less than 6 months prior to inclusion
- Having less than 20 natural teeth
About this study
Official title: Effects of Non-surgical Treatment of Chronic Periodontitis on Insulin Resistance and Glucose Tolerance in Non-diabetic Subjects
This study was aimed at assessing the effects of non-surgical periodontal treatment (NSPT) of chronic periodontitis on insulin sensitivity, glucose tolerance, and serum C-reactive protein(CRP) level amongst non-diabetic subjects.
Read the detailed description
Subjects with chronic periodontitis will undergo non-surgical periodontal treatment (NSPT) consisting of a complete scaling, polishing, root planning, and the irrigation of periodontal pockets with a 10% povidone iodine solution. Periodontal parameters (plaque index, gingival bleeding index, pocket depth, and clinical attachment loss), insulin sensitivity using KITT, glucose tolerance using oral glucose tolerance test and serum CRP level by immunoturbidimetry will be measured before and 3 months after the NSPT.
- Conditions
- Periodontitis, Prediabetes
- Being tested
- non-surgical periodontal treatment
- Keywords
- periodontitis, diabetes, prevention, impaired glucose tolerance, insulin resistance
- Medical subject headings
- Periodontitis, Prediabetic State, Diabetes Mellitus, Glucose Intolerance, Insulin Resistance
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 session of complete scaling, polishing, root planning, and the irrigation of periodontal pockets with a 10% povidone iodine solution
| Study group | Role | What they receive |
|---|---|---|
| non-surgical periodontal treatment | Experimental | One session of non-surgical periodontal treatment consisting of a complete scaling, polishing, root planning, and the irrigation of periodontal pockets with a 10% povidone iodine solution. Receives: Procedure: non-surgical periodontal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose tolerance
change in 2-hour post load blood glucose
Measured: 3 months
Insulin sensitivity
change in glucose disappearance rate during the short insulin tolerance test
Measured: 3 months
Secondary outcomes (2)
Composite periodontal health
Change in plaque index, gingival bleeding index, pocket depth, and clinical attachment loss
Measured: 3 months
Inflammation
change in Serum CRP
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2016 (estimated)
- Study startDec 2014
- Primary completionMay 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yaounde Central Hospital
- Sponsor type
- Other government
- Collaborators
- University of Yaounde 1
- Responsible party
- Principal investigator, Sobngwi Eugene, Yaounde Central Hospital
- Investigators
- Eugene Sobngwi, MD, PhD, Principal investigator, University of Yaoundé 1 and Yaoundé Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02830113
- Sponsor's protocol ID
- CNO20155
- Acronym
- PARODIA2
- Status last verified
- Jul 2016
- First submitted
- 8 Jul 2016
- Last updated
- 12 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nana Nana AR, Tsobgny Tsague NF, Lontchi-Yimagou E, Bengondo Messanga C, Tankeu A, Katte JC, Balti Vounsia E, Dehayem M, Sobngwi E. Effects of non-surgical treatment of chronic periodontitis on insulin resistance and glucose tolerance in subjects without diabetes (PARODIA 2 study). J Investig Med. 2021 Oct;69(7):1377-1381. doi: 10.1136/jim-2021-001831. Epub 2021 Jul 14.
PubMed 34261767
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Non-surgical Treatment of Chronic Periodontitis on Insulin Resistance and Glucose Tolerance in Non-diabetic Subjects
- ClinicalTrials.gov ID
- NCT02830113
- Acronym / sponsor ID
- PARODIA2 / CNO20155
- Conditions
- Periodontitis, Prediabetes
- Keywords
- periodontitis, diabetes, prevention, impaired glucose tolerance, insulin resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Yaounde Central HospitalOther government
- Collaborators
- University of Yaounde 1
- Study start
- Dec 2014
- Primary completion
- May 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 12 Jul 2016 (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.
This study was aimed at assessing the effects of non-surgical periodontal treatment (NSPT) of chronic periodontitis on insulin sensitivity, glucose tolerance, and serum C-reactive protein(CRP) level amongst non-diabetic subjects.
Detailed description
Subjects with chronic periodontitis will undergo non-surgical periodontal treatment (NSPT) consisting of a complete scaling, polishing, root planning, and the irrigation of periodontal pockets with a 10% povidone iodine solution. Periodontal parameters (plaque index, gingival bleeding index, pocket depth, and clinical attachment loss), insulin sensitivity using KITT, glucose tolerance using oral glucose tolerance test and serum CRP level by immunoturbidimetry will be measured before and 3 months after the NSPT.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| non-surgical periodontal treatment | Experimental | Procedure: non-surgical periodontal treatmentOne session of non-surgical periodontal treatment consisting of a complete scaling, polishing, root planning, and the irrigation of periodontal pockets with a 10% povidone iodine solution. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Chronic periodontitis
- Non diabetic individual
Key exclusion criteria (3 listed)
- Known diabetes
- Periodontal treatment less than 6 months prior to inclusion
- Having less than 20 natural teeth
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 session of complete scaling, polishing, root planning, and the irrigation of periodontal pockets with a 10% povidone iodine solution | Procedure or surgery | non-surgical periodontal treatment |
Primary outcome
Glucose tolerance
Time frame: 3 months
change in 2-hour post load blood glucose
Insulin sensitivity
Time frame: 3 months
change in glucose disappearance rate during the short insulin tolerance test
2 secondary outcomes
Composite periodontal health
Time frame: 3 months
Inflammation
Time frame: 3 months
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 12 Jul 2016.
- Derived from this study: PubMed 34261767Nana Nana AR, Tsobgny Tsague NF, Lontchi-Yimagou E, Bengondo Messanga C, Tankeu A, Katte JC, Balti Vounsia E, Dehayem M, Sobngwi E. Effects of non-surgical treatment of chronic periodontitis on insulin resistance and glucose tolerance in subjects without diabetes (PARODIA 2 study). J Investig Med. 2021 Oct;69(7):1377-1381. doi: 10.1136/jim-2021-001831. Epub 2021 Jul 14.
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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.
Eugene Sobngwi, MD, PhD principal investigator
University of Yaoundé 1 and Yaoundé Central Hospital
Questions about this trial
What is this clinical trial studying?
A study testing non-surgical periodontal treatment in people with Periodontitis and Prediabetes, run by Yaounde Central Hospital.
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 2 inclusion and 3 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 12 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Glucose tolerance (time frame: 3 months). 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?
On the ClinicalTrials.gov record for NCT02830113, which also lists 1 linked publication.
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 12 Jul 2016.