Periodontal DiseaseNCT03908606
Serum Hs-CRP in Periodontitis Patients With or Without Diabetes
A study testing Scaling and root planing in people with Periodontal Disease and Diabetes Mellitus, Type 2, run by Cairo University at 1 site in Egypt.
Trial summary
the aim of this study was to assess serum levels of high sensitivity c reactive protein in periodontitis patients with and without type 2 diabetes in a trial to analyze its prognostic effect following non-surgical periodontal therapy. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Periodontal Disease, Diabetes Mellitus, Type 2
- What is being tested?
- Scaling and root planing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Apr 2018to 2 Jan 2019
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Diabetic patients type 2
- Periodontitis patients
Who cannot join
- Smokers
- Pregnant females
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prognostic Value of Serum Hs-CRP in Periodontitis Patients With or Without Type 2 Diabetes Following Non-surgical Periodontal Therapy
the aim of this study was to assess serum levels of high sensitivity c reactive protein in periodontitis patients with and without type 2 diabetes in a trial to analyze its prognostic effect following non-surgical periodontal therapy.
Read the detailed description
Periodontitis and diabetes are chronic disorders with a two-way correlation as they can both stimulate an inflammatory response with subsequent formation of inflammatory mediators and cytokines. C reactive protein is an inflammatory plasma marker having a role in the systemic reaction to inflammation. thus, our aim in the current study was to evaluate serum levels of high sensitivity c reactive protein in periodontitis patients with and without type 2 diabetes in a trial to analyze its prognostic effect following non-surgical periodontal therapy. A total of 60 patients were enrolled in this study. ELISA was used for determination of hs- CRP. Non- surgical periodontal therapy was carried out for all periodontitis patients.
- Conditions
- Periodontal Disease, Diabetes Mellitus, Type 2
- Being tested
- Scaling and root planing
- Medical subject headings
- Periodontal Diseases, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scaling and root planingProcedure or surgery
Supra and subgingival scaling and root planing.
| Study group | Role | What they receive |
|---|---|---|
| Periodontitis patients with diabetes type 2 | Experimental | scaling and root planing was administered to all patients. Serum samples were collected before and after treatment to assess hs-CRP levels. Glycated hemoglobin was measured before and after treatment Receives: Procedure: Scaling and root planing |
| Periodontitis patients | Experimental | scaling and root planing will be done to periodontitis patients. Serum samples were collected before and after treatment to assess hs-CRP levels. Receives: Procedure: Scaling and root planing |
| Healthy control group | No intervention | We measured serum levels of hs-CRP in all healthy control subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical attachment level
gain in clinical attachment level
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 posted9 Apr 2019
- Study start11 Apr 2018
- Primary completion2 Jan 2019
- Study completion2 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseaseStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gihane Gharib Madkour, Cairo University
- Investigators
- Gihane Madkour, Prof, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03908606
- Sponsor's protocol ID
- 1281976
- Status last verified
- Apr 2019
- First submitted
- 6 Apr 2019
- Last updated
- 9 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Serum Hs-CRP in Periodontitis Patients With or Without Type 2 Diabetes Following Non-surgical Periodontal Therapy
- ClinicalTrials.gov ID
- NCT03908606
- Acronym / sponsor ID
- 1281976
- Conditions
- Periodontal Disease, Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 11 Apr 2018 (actual)
- Primary completion
- 2 Jan 2019 (actual)
- Study completion
- 2 Jan 2019 (actual)
- First posted
- 9 Apr 2019 (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 aim of this study was to assess serum levels of high sensitivity c reactive protein in periodontitis patients with and without type 2 diabetes in a trial to analyze its prognostic effect following non-surgical periodontal therapy.
Detailed description
Periodontitis and diabetes are chronic disorders with a two-way correlation as they can both stimulate an inflammatory response with subsequent formation of inflammatory mediators and cytokines. C reactive protein is an inflammatory plasma marker having a role in the systemic reaction to inflammation. thus, our aim in the current study was to evaluate serum levels of high sensitivity c reactive protein in periodontitis patients with and without type 2 diabetes in a trial to analyze its prognostic effect following non-surgical periodontal therapy. A total of 60 patients were enrolled in this study. ELISA was used for determination of hs- CRP. Non- surgical periodontal therapy was carried out for all periodontitis patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Periodontitis patients with diabetes type 2 | Experimental | Procedure: Scaling and root planingscaling and root planing was administered to all patients. Serum samples were collected before and after treatment to assess hs-CRP levels. Glycated hemoglobin was measured before and after treatment |
| Periodontitis patients | Experimental | Procedure: Scaling and root planingscaling and root planing will be done to periodontitis patients. Serum samples were collected before and after treatment to assess hs-CRP levels. |
| Healthy control group | No intervention | –We measured serum levels of hs-CRP in all healthy control subjects |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Diabetic patients type 2
- Periodontitis patients
Key exclusion criteria (2 listed)
- Smokers
- Pregnant females
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 |
|---|---|---|
| Scaling and root planingSupra and subgingival scaling and root planing. | Procedure or surgery | Periodontitis patients, Periodontitis patients with diabetes type 2 |
Primary outcome
clinical attachment level
Time frame: 3 months
gain in clinical attachment level
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 9 Apr 2019.
- Individual participant dataSharing planned: No
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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.
Gihane Madkour, Prof study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scaling and root planing in people with Periodontal Disease and Diabetes Mellitus, Type 2, 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 2 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 9 Apr 2019. 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?
clinical attachment level (time frame: 3 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 9 Apr 2019.