Chronic PeriodontitisNCT02174146
Leptin and Visfatin in Diabetic Patients With Periodontitis Before and After Periodontal Therapy
A study testing non-surgical periodontal therapy in people with Chronic Periodontitis and Type 2 Diabetes Mellitus, run by Cairo University at 1 site in Egypt.
Trial summary
1. Are adipokines involved in pathogenesis of periodontal disease in diabetic patients? 2. Does their level change after periodontal therapy? Read more about this study
- Who is it for?
- Ages 35 to 54 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Periodontitis, Type 2 Diabetes Mellitus
- What is being tested?
- non-surgical periodontal therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2013to Dec 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 35 to 54 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- diabetic patients having diabetes mellitus ≥5 years prior to the study.
- chronic periodontitis with clinical attachment loss > 5 mm.
- otherwise systemically healthy subjects.
Who cannot join
- any known systemic diseases other than diabetes.
- pregnancy or lactation.
- smokers.
- receiving periodontal treatment in the last 6 months.
- taking any drugs or medications other than anti-diabetic drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Non-surgical Periodontal Therapy on Leptin and Visfatin Expression in Gingival Tissues of Chronic Periodontitis With and Without Type 2 Diabetes Mellitus: A Study Utilizing ELISA and Real Time PCR
- Are adipokines involved in pathogenesis of periodontal disease in diabetic patients?
- Does their level change after periodontal therapy?
Read the detailed description
Patients with chronic periodontitis only and patients with chronic periodontitis and diabetes were evaluated for levels of leptin and visfatin in the gingival tissues before and after non-surgical periodontal therapy.
- Conditions
- Chronic Periodontitis, Type 2 Diabetes Mellitus
- Being tested
- non-surgical periodontal therapy
- Keywords
- leptin, visfatin, chronic periodontitis, diabetes mellitus, non-surgical periodontal therapy
- Medical subject headings
- Chronic Periodontitis, Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-surgical periodontal therapyProcedure or surgery
Also called scaling and root planing
supra and subgingival debridement
| Study group | Role | What they receive |
|---|---|---|
| non-surgical therapy | Other | non-surgical periodontal therapy with ultrasonic scalers and periodontal curettes Receives: Procedure: non-surgical periodontal therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
visfatin levels in gingival tissues
estimation of protein and gene expression of visfatin in patients with chronic periodontitis only and diabetic patients with periodontitis before and after non-surgical periodontal therapy..
Measured: 3 months
leptin levels in gingival tissue
estimation of protein and gene expression of leptin in patients with chronic periodontitis only and diabetic patients with periodontitis before and after non-surgical periodontal therapy..
Measured: 3 months
Secondary outcomes (2)
pocket depth
estimation of pocket depth in patients with chronic periodontitis only and diabetic patients with periodontitis before and after non-surgical periodontal therapy.
Measured: 3 months
clinical attachment level
estimation of clinical attachment level in patients with chronic periodontitis only and diabetic patients with periodontitis before and after non-surgical periodontal therapy.
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 posted25 Jun 2014 (estimated)
- Study startSep 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Chronic PeriodontitisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Ayman Ghallab, Cairo University
- Investigators
- Noha Ghallab, M.D., Principal investigator, Associate Professor of periodontology faulty of oral and dental medicine Cairo Unv.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02174146
- Sponsor's protocol ID
- leptin_visfatin_diabetes
- Status last verified
- Jun 2014
- First submitted
- 23 Jun 2014
- Last updated
- 25 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pradeep AR, Raghavendra NM, Sharma A, Patel SP, Raju A, Kathariya R, Rao NS, Naik SB. Association of serum and crevicular visfatin levels in periodontal health and disease with type 2 diabetes mellitus. J Periodontol. 2012 May;83(5):629-34. doi: 10.1902/jop.2011.110272. Epub 2011 Oct 3.
PubMed 21966944Pradeep AR, Raghavendra NM, Prasad MV, Kathariya R, Patel SP, Sharma A. Gingival crevicular fluid and serum visfatin concentration: their relationship in periodontal health and disease. J Periodontol. 2011 Sep;82(9):1314-9. doi: 10.1902/jop.2011.100690. Epub 2011 Feb 10.
PubMed 21309715Raghavendra NM, Pradeep AR, Kathariya R, Sharma A, Rao NS, Naik SB. Effect of non surgical periodontal therapy on gingival crevicular fluid and serum visfatin concentration in periodontal health and disease. Dis Markers. 2012;32(6):383-8. doi: 10.3233/DMA-2012-0897.
PubMed 22684235Karthikeyan BV, Pradeep AR. Leptin levels in gingival crevicular fluid in periodontal health and disease. J Periodontal Res. 2007 Aug;42(4):300-4. doi: 10.1111/j.1600-0765.2006.00948.x.
PubMed 17559625Karthikeyan BV, Pradeep AR. Gingival crevicular fluid and serum leptin: their relationship to periodontal health and disease. J Clin Periodontol. 2007 Jun;34(6):467-72. doi: 10.1111/j.1600-051X.2007.01078.x. Epub 2007 Apr 23.
PubMed 17451417Johnson RB, Serio FG. Leptin within healthy and diseased human gingiva. J Periodontol. 2001 Sep;72(9):1254-7. doi: 10.1902/jop.2000.72.9.1254.
PubMed 11577959Bozkurt FY, Yetkin Ay Z, Sutcu R, Delibas N, Demirel R. Gingival crevicular fluid leptin levels in periodontitis patients with long-term and heavy smoking. J Periodontol. 2006 Apr;77(4):634-40. doi: 10.1902/jop.2006.050277.
PubMed 16584344
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Non-surgical Periodontal Therapy on Leptin and Visfatin Expression in Gingival Tissues of Chronic Periodontitis With and Without Type 2 Diabetes Mellitus: A Study Utilizing ELISA and Real Time PCR
- ClinicalTrials.gov ID
- NCT02174146
- Acronym / sponsor ID
- leptin_visfatin_diabetes
- Conditions
- Chronic Periodontitis, Type 2 Diabetes Mellitus
- Keywords
- leptin, visfatin, chronic periodontitis, diabetes mellitus, non-surgical periodontal therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 25 Jun 2014 (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.
- Are adipokines involved in pathogenesis of periodontal disease in diabetic patients?
- Does their level change after periodontal therapy?
Detailed description
Patients with chronic periodontitis only and patients with chronic periodontitis and diabetes were evaluated for levels of leptin and visfatin in the gingival tissues before and after non-surgical periodontal therapy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| non-surgical therapy | Other | Procedure: non-surgical periodontal therapynon-surgical periodontal therapy with ultrasonic scalers and periodontal curettes |
Who may qualify
- Ages
- 35 to 54 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- diabetic patients having diabetes mellitus ≥5 years prior to the study.
- chronic periodontitis with clinical attachment loss > 5 mm.
- otherwise systemically healthy subjects.
Key exclusion criteria (5 listed)
- any known systemic diseases other than diabetes.
- pregnancy or lactation.
- smokers.
- receiving periodontal treatment in the last 6 months.
- taking any drugs or medications other than anti-diabetic drugs.
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 therapyAlso: scaling and root planingsupra and subgingival debridement | Procedure or surgery | non-surgical therapy |
Primary outcome
visfatin levels in gingival tissues
Time frame: 3 months
estimation of protein and gene expression of visfatin in patients with chronic periodontitis only and diabetic patients with periodontitis before and after non-surgical periodontal therapy..
leptin levels in gingival tissue
Time frame: 3 months
estimation of protein and gene expression of leptin in patients with chronic periodontitis only and diabetic patients with periodontitis before and after non-surgical periodontal therapy..
2 secondary outcomes
pocket depth
Time frame: 3 months
clinical attachment level
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 25 Jun 2014.
- Results publication: PubMed 21966944Pradeep AR, Raghavendra NM, Sharma A, Patel SP, Raju A, Kathariya R, Rao NS, Naik SB. Association of serum and crevicular visfatin levels in periodontal health and disease with type 2 diabetes mellitus. J Periodontol. 2012 May;83(5):629-34. doi: 10.1902/jop.2011.110272. Epub 2011 Oct 3.
- Results publication: PubMed 21309715Pradeep AR, Raghavendra NM, Prasad MV, Kathariya R, Patel SP, Sharma A. Gingival crevicular fluid and serum visfatin concentration: their relationship in periodontal health and disease. J Periodontol. 2011 Sep;82(9):1314-9. doi: 10.1902/jop.2011.100690. Epub 2011 Feb 10.
- Results publication: PubMed 22684235Raghavendra NM, Pradeep AR, Kathariya R, Sharma A, Rao NS, Naik SB. Effect of non surgical periodontal therapy on gingival crevicular fluid and serum visfatin concentration in periodontal health and disease. Dis Markers. 2012;32(6):383-8. doi: 10.3233/DMA-2012-0897.
- Results publication: PubMed 17559625Karthikeyan BV, Pradeep AR. Leptin levels in gingival crevicular fluid in periodontal health and disease. J Periodontal Res. 2007 Aug;42(4):300-4. doi: 10.1111/j.1600-0765.2006.00948.x.
- Results publication: PubMed 17451417Karthikeyan BV, Pradeep AR. Gingival crevicular fluid and serum leptin: their relationship to periodontal health and disease. J Clin Periodontol. 2007 Jun;34(6):467-72. doi: 10.1111/j.1600-051X.2007.01078.x. Epub 2007 Apr 23.
- Results publication: PubMed 11577959Johnson RB, Serio FG. Leptin within healthy and diseased human gingiva. J Periodontol. 2001 Sep;72(9):1254-7. doi: 10.1902/jop.2000.72.9.1254.
- Results publication: PubMed 16584344Bozkurt FY, Yetkin Ay Z, Sutcu R, Delibas N, Demirel R. Gingival crevicular fluid leptin levels in periodontitis patients with long-term and heavy smoking. J Periodontol. 2006 Apr;77(4):634-40. doi: 10.1902/jop.2006.050277.
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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.
Noha Ghallab, M.D. principal investigator
Associate Professor of periodontology faulty of oral and dental medicine Cairo Unv.
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 therapy in people with Chronic Periodontitis and Type 2 Diabetes Mellitus, run by Cairo University at 1 site in Egypt.
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 5 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 25 Jun 2014. 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 Egypt. 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?
visfatin levels in gingival tissues (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 NCT02174146, which also lists 7 linked publications.
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 25 Jun 2014.