Periodontal DiseasesNCT04332965
Periostin and Non-Surgical Periodontal Treatment
A study testing Non-Surgical Periodontal Treatment in people with Periodontal Diseases, run by Kırıkkale University.
Trial summary
A total of 90 subjects, 30 patients with chronic periodontitis, 30 with gingivitis and 30 periodontally healthy subjects were included. Patients with periodontal disease received non-surgical periodontal treatment. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- Non-Surgical Periodontal Treatment
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Apr 2018
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Clinical diagnosis of chronic periodontitis
- Clinical diagnosis of gingivitis
- Clinical diagnosis of periodontal health
Who cannot join
- have any systemic disease
- to be alcohol consumer
- to receive any periodontal therapy in the past 6 months
- to take any drugs regularly
- to be pregnant and/or lactate
About this study
Official title: The Effect of Non-Surgical Periodontal Treatment on Gingival Crevicular Fluid Periostin Levels in Patients With Gingivitis and Chronic Periodontitis
A total of 90 subjects, 30 patients with chronic periodontitis, 30 with gingivitis and 30 periodontally healthy subjects were included. Patients with periodontal disease received non-surgical periodontal treatment. Gingival crevicular fluid periostin levels were assessed at baseline, at the 6th week and the 3rd month after treatment.
Read the detailed description
Periostin is commonly found in collagen-rich tissues, which is thought to affect the production of collagen fibers. Additionally, periostin is synthesized in tissues exposed to constant mechanical forces such as the periosteum, periodontal ligament, tendon, heart valve and skin. Periostin mediates inflammation and fibrosis during diseases of various organs, including the heart, lung, kidney, skin, liver, skeletal muscle and retina.
This study evaluated periostin levels in gingival crevicular fluid from patients with chronic periodontitis, gingivitis and periodontally healthy as well as the effect of non-surgical periodontal treatment on gingival crevicular fluid periostin levels.
- Conditions
- Periodontal Diseases
- Being tested
- Non-Surgical Periodontal Treatment
- Keywords
- Chronic periodontitis, Gingival crevicular fluid, Gingivitis, Non-surgical periodontal treatment, Periostin
- Medical subject headings
- Periodontal Diseases, Chronic Periodontitis, Gingivitis
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
Also called Initial periodontal therapy
Scaling and root planing and polishing with specific curettes were performed to patients and oral hygiene education was provided to each patient.
| Study group | Role | What they receive |
|---|---|---|
| Patients with chronic periodontitis | Experimental | Patients with CP (n=30) had teeth with 30% periodontal bone loss and ≥ 2 non-adjacent sites per quadrant with probing depth (PD) ≥ 5 mm and bleeding on probing. Receives: Procedure: Non-Surgical Periodontal Treatment |
| Patients with gingivitis | Experimental | Participants with G (n=30) had gingival index ≥ 2 and other inflammation signs. Receives: Procedure: Non-Surgical Periodontal Treatment |
| Participants with periodontal healthy | No intervention | The H group (n=30) consisted of individuals with no attachment loss, no history of periodontal disease, PD ≤3 mm, and whole-mouth bleeding scores <10%. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in periostin
Total amount of Periostin (pg/30 sec) in gingival crevicular fluid
Measured: Baseline, 6th week and 3rd month
Secondary outcomes (1)
Change in periodontal clinical parameter
Clinical attachment level (mm) (from cemento-enamel junction to the base of periodontal pocket)
Measured: Baseline, 6th week and 3rd month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2020
- Study startJan 2017
- Primary completionJan 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies 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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru Olgun Erdemir, Kırıkkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04332965
- Sponsor's protocol ID
- 2017/43
- Status last verified
- Apr 2020
- First submitted
- 1 Apr 2020
- Last updated
- 3 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Non-Surgical Periodontal Treatment on Gingival Crevicular Fluid Periostin Levels in Patients With Gingivitis and Chronic Periodontitis
- ClinicalTrials.gov ID
- NCT04332965
- Acronym / sponsor ID
- 2017/43
- Conditions
- Periodontal Diseases
- Keywords
- Chronic periodontitis, Gingival crevicular fluid, Gingivitis, Non-surgical periodontal treatment, Periostin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 3 Apr 2020 (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.
A total of 90 subjects, 30 patients with chronic periodontitis, 30 with gingivitis and 30 periodontally healthy subjects were included. Patients with periodontal disease received non-surgical periodontal treatment. Gingival crevicular fluid periostin levels were assessed at baseline, at the 6th week and the 3rd month after treatment.
Detailed description
Periostin is commonly found in collagen-rich tissues, which is thought to affect the production of collagen fibers. Additionally, periostin is synthesized in tissues exposed to constant mechanical forces such as the periosteum, periodontal ligament, tendon, heart valve and skin. Periostin mediates inflammation and fibrosis during diseases of various organs, including the heart, lung, kidney, skin, liver, skeletal muscle and retina.
This study evaluated periostin levels in gingival crevicular fluid from patients with chronic periodontitis, gingivitis and periodontally healthy as well as the effect of non-surgical periodontal treatment on gingival crevicular fluid periostin levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with chronic periodontitis | Experimental | Procedure: Non-Surgical Periodontal TreatmentPatients with CP (n=30) had teeth with 30% periodontal bone loss and ≥ 2 non-adjacent sites per quadrant with probing depth (PD) ≥ 5 mm and bleeding on probing. |
| Patients with gingivitis | Experimental | Procedure: Non-Surgical Periodontal TreatmentParticipants with G (n=30) had gingival index ≥ 2 and other inflammation signs. |
| Participants with periodontal healthy | No intervention | –The H group (n=30) consisted of individuals with no attachment loss, no history of periodontal disease, PD ≤3 mm, and whole-mouth bleeding scores <10%. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of chronic periodontitis
- Clinical diagnosis of gingivitis
- Clinical diagnosis of periodontal health
Key exclusion criteria (5 listed)
- have any systemic disease
- to be alcohol consumer
- to receive any periodontal therapy in the past 6 months
- to take any drugs regularly
- to be pregnant and/or lactate
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 TreatmentAlso: Initial periodontal therapyScaling and root planing and polishing with specific curettes were performed to patients and oral hygiene education was provided to each patient. | Procedure or surgery | Patients with chronic periodontitis, Patients with gingivitis |
Primary outcome
Change in periostin
Time frame: Baseline, 6th week and 3rd month
Total amount of Periostin (pg/30 sec) in gingival crevicular fluid
1 secondary outcome
Change in periodontal clinical parameter
Time frame: Baseline, 6th week and 3rd month
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 3 Apr 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Non-Surgical Periodontal Treatment in people with Periodontal Diseases, run by Kırıkkale University.
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 3 Apr 2020. 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?
Change in periostin (time frame: Baseline, 6th week and 3rd month). 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 3 Apr 2020.