PeriodontitisNCT04383561
Relationship Between LRG and Periodontal Disease
A study testing Non-surgical periodontal treatment and Oral hygiene instructions in people with Periodontitis and Acute-Phase Response, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to investigate gingival crevicular fluid (GCF) and serum levels of LRG, interleukin (IL)-6 and tumor necrosis factor (TNF)-α in patients with periodontitis before and after non-surgical periodontal treatment. Read more about this study
- Who is it for?
- Ages 26 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Acute-Phase Response, Inflammation
- What is being tested?
- Non-surgical periodontal treatment and Oral hygiene instructions
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Sep 2019to 15 Feb 2020
- 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 26 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 25-50 years of age
- having at least 20 natural teeth, excluding third molars
- having no systemic disease
- non-smokers
- criteria for healthy control group: BOP < 10% and PD ≤ 3 mm without clinical attachment loss or radiographic sign of alveolar bone destruction
- criteria for stage 3 periodontitis group: interdental CAL ≥ 5 mm at least 2 non-adjacent teeth, PD ≥ 6 mm and radiographic bone loss extending to the mid-third of the root or beyond.
Who cannot join
- having any systemic diseases,
- smoking
- current pregnancy or lactation
- a history of periodontal treatment in the past 6 months
- using antibiotic, anti-inflammatory drugs or any other drugs within the past 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Leucin-rich alpha2 Glycoprotein (LRG): A Novel Acute Phase Protein Related With Stage 3 Periodontitis
This study aimed to investigate gingival crevicular fluid (GCF) and serum levels of LRG, interleukin (IL)-6 and tumor necrosis factor (TNF)-α in patients with periodontitis before and after non-surgical periodontal treatment.
Read the detailed description
Twenty-five stage 3 periodontitis and twenty-five periodontally healthy individuals were enrolled in the study. Clinical periodontal measurements were recorded; periodontitis patients received non-surgical periodontal treatment, and GCF and serum samples were obtained at baseline and at 6 weeks after treatment. LRG, IL-6 and TNF-α were determined by ELISA.
- Conditions
- Periodontitis, Acute-Phase Response, Inflammation
- Being tested
- Non-surgical periodontal treatment, Oral hygiene instructions
- Keywords
- periodontitis, gingival crevicular fluid, serum
- Medical subject headings
- Periodontitis, Acute-Phase Reaction, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-surgical periodontal treatmentOther
Scaling and root planing (SRP), in four clinical visits
Oral hygiene instructionsOther
Oral hygiene instructions includes brushing with the modified Bass technique, interdental cleaning with dental floss and interdental brushes.
| Study group | Role | What they receive |
|---|---|---|
| stage 3 periodontitis | Active comparator | GCF and serum samples were collected before and after treatment from periodontitis patients. Receives: Other: Non-surgical periodontal treatment; Other: Oral hygiene instructions |
| Periodontally healthy controls | Placebo comparator | GCF and serum samples were collected from periodontally healthy controls at baseline for once. Receives: Other: Oral hygiene instructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the levels of biochemical parameters
The levels LRG, IL-6 and TNF-α were determined to define the diagnostic and prognostic potential as a biomarker in periodontitis.
Measured: Baseline and 6 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start30 Sep 2019
- Primary completion15 Jan 2020
- Study completion15 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Collaborators
- Giresun University, Bulent Ecevit University
- Responsible party
- Principal investigator, Zeynep Pinar KELES YUCEL, Giresun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04383561
- Sponsor's protocol ID
- KAEK-92
- Status last verified
- May 2020
- First submitted
- 4 May 2020
- Last updated
- 12 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leucin-rich alpha2 Glycoprotein (LRG): A Novel Acute Phase Protein Related With Stage 3 Periodontitis
- ClinicalTrials.gov ID
- NCT04383561
- Acronym / sponsor ID
- KAEK-92
- Conditions
- Periodontitis, Acute-Phase Response, Inflammation
- Keywords
- periodontitis, gingival crevicular fluid, serum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Collaborators
- Giresun University, Bulent Ecevit University
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 15 Jan 2020 (actual)
- Study completion
- 15 Feb 2020 (actual)
- First posted
- 12 May 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.
This study aimed to investigate gingival crevicular fluid (GCF) and serum levels of LRG, interleukin (IL)-6 and tumor necrosis factor (TNF)-α in patients with periodontitis before and after non-surgical periodontal treatment.
Detailed description
Twenty-five stage 3 periodontitis and twenty-five periodontally healthy individuals were enrolled in the study. Clinical periodontal measurements were recorded; periodontitis patients received non-surgical periodontal treatment, and GCF and serum samples were obtained at baseline and at 6 weeks after treatment. LRG, IL-6 and TNF-α were determined by ELISA.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stage 3 periodontitis | Active comparator | Other: Non-surgical periodontal treatment, Other: Oral hygiene instructionsGCF and serum samples were collected before and after treatment from periodontitis patients. |
| Periodontally healthy controls | Placebo comparator | Other: Oral hygiene instructionsGCF and serum samples were collected from periodontally healthy controls at baseline for once. |
Who may qualify
- Ages
- 26 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 25-50 years of age
- having at least 20 natural teeth, excluding third molars
- having no systemic disease
- non-smokers
- criteria for healthy control group: BOP < 10% and PD ≤ 3 mm without clinical attachment loss or radiographic sign of alveolar bone destruction
Key exclusion criteria (5 listed)
- having any systemic diseases,
- smoking
- current pregnancy or lactation
- a history of periodontal treatment in the past 6 months
- using antibiotic, anti-inflammatory drugs or any other drugs within the past 6 months.
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 treatmentScaling and root planing (SRP), in four clinical visits | Other | stage 3 periodontitis |
| Oral hygiene instructionsOral hygiene instructions includes brushing with the modified Bass technique, interdental cleaning with dental floss and interdental brushes. | Other | Periodontally healthy controls, stage 3 periodontitis |
Primary outcome
Changes in the levels of biochemical parameters
Time frame: Baseline and 6 weeks after treatment
The levels LRG, IL-6 and TNF-α were determined to define the diagnostic and prognostic potential as a biomarker in periodontitis.
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 May 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.
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 and Oral hygiene instructions in people with Periodontitis and Acute-Phase Response, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
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 6 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 12 May 2020. 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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?
Changes in the levels of biochemical parameters (time frame: Baseline and 6 weeks after treatment). 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 12 May 2020.