PeriodontitisNCT06326073
Interaction Between Smoking, GCF Periostin, IL17A, IL17E and Non-surgical Periodontal Therapy
A study testing Non Surgical Periodontal Treatment in people with Periodontitis and Smoking, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
It was aimed to evaluate the changes in the levels of Periostin, IL-17A and IL-17E cytokines in the gingival crevicular fluid (GCF) of periodontitis patients which non-surgical (Phase I) periodontal treatment applied to and their interactions with smoking. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Smoking
- 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
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2019to 1 Jul 2021
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- generalized stage 3 periodontitis or periodontally healthy;
- smoker ((≥10 cigarettes/day for >5 years) or nonsmoker (never smoked in their lifetime);
- not have received any periodontal treatment in the last 6 months, took any antibiotics, anti-inflammatory drugs regularly and for female subjects, not to be pregnant, lactating, or menopause.
Who cannot join
- Under 18 years of age
- Those with a systemic disease
- Cancer patients, those with a history of chemotherapy and radiotherapy
- Pregnant and breastfeeding women
- Those who smoke less than 10 cigarettes a day and those who quit smoking
- Having received orthodontic treatment in the last 6 months
- Using antibiotics, anti-inflammatory or any medication in the last 6 months
- Those who do not consent voluntarily
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ondokuz Mayıs University Faculty of Dentistry Department of Periodontology
Samsun, 55270
About this study
Official title: Evaluation of the GCF Periostin, IL-17A and IL-17E Levels of Smoking and Non-smoking Periodontitis Patients Received Periodontal Treatment: Short-term Follow-up Study
It was aimed to evaluate the changes in the levels of Periostin, IL-17A and IL-17E cytokines in the gingival crevicular fluid (GCF) of periodontitis patients which non-surgical (Phase I) periodontal treatment applied to and their interactions with smoking. The study included systemic healthy smokers(SP)(n:11) and non-smokers(P)(n:11) with periodontitis, smokers (SS)(n:11) and non-smokers(S)(n:11) with periodontal healthy individuals Phase I periodontal treatment was applied to the groups with periodontitis. Before treatment (day 0), clinical measurements evaluating periodontal status were recorded and GCF samples were collected. GCF samples were collected from the same tooth regions on the 15th and 30th days after treatment and clinical measurements were repeated. GCF Periostin, IL-17A and IL-17E levels were determined by ELISA method. All data were evaluated statistically.
Read the detailed description
The SH and H groups' patients were instructed to visit for routine controls without receiving any periodontal treatment. However, after the GCF sampling, patients in the SP and P groups received Non-surgical periodontal treatment(NSPT) included detailed oral hygiene instruction and reinforcement in conjunction with scaling and root planning as a full mouth debridement protocol in a single session They were instructed to refrain from using any chemicals, including mouthwash, to remove plaque.
The periodontitis patients received a follow-up call on the 15th and 30th days following treatment. The GCF sampling procedure was first repeated on the teeth from which a previous GCF sample had been taken. Then, values for the clinical examination parameters (PI, GI, BOP, PD, and CAL) were once again measured and recorded. Daily plaque care efficacy or deficiency was checked and/or reinforced at every recall. All these procedures were performed by a single investigator.
- Conditions
- Periodontitis, Smoking
- Being tested
- Non Surgical Periodontal Treatment
- Keywords
- non surgical periodontal therapy, smoking, periostin, IL-17, gingival crevicular fluid
- Medical subject headings
- Periodontitis, Smoking
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
Phase 1 periodontal (full mouth debridement) treatment was applied to groups with periodontitis in one session.
| Study group | Role | What they receive |
|---|---|---|
| Group I: SP | Experimental | smokers with periodontitis Receives: Procedure: Non Surgical Periodontal Treatment |
| Group II: P | Experimental | non-smokers with periodontitis Receives: Procedure: Non Surgical Periodontal Treatment |
| Group III: SH | No intervention | smokers with periodontal healthy individuals |
| Group IV: H | No intervention | non-smokers with periodontal healthy individuals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Periostin levels
The effect of non-surgical periodontal treatment in gingival crevicular fluid periostin levels
Measured: 0-15-30 days
Evaluation of IL-17A levels
The effect of non-surgical periodontal treatment in gingival crevicular fluid IL-17A levels
Measured: 0-15-30 days
Evaluation of IL-17E levels
The effect of non-surgical periodontal treatment in gingival crevicular fluid IL-17E levels
Measured: 0-15-30 days
Secondary outcomes (1)
Interaction Between Smoking and GCF Periostin, IL17A, IL17E levels
Comparisons between groups were made to evaluate the effect of smoking on non-surgical periodontal treatment.
Measured: 0-15-30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start1 Jul 2019
- Primary completion1 Feb 2021
- Study completion1 Jul 2021
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.
- More trials run by Ondokuz Mayıs 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study included systemic healthy smokers(SP)(n:11) and non-smokers(P)(n:11) with periodontitis, smokers (SH)(n:11) and non-smokers(H)(n:11) with periodontal healthy individuals
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sule Ozdogan, Ondokuz Mayıs University
- Investigators
- Muge Luftioglu, Study director, Ondokuz Mayıs Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06326073
- Sponsor's protocol ID
- OMUKAEK2019/324
- Status last verified
- Mar 2024
- First submitted
- 16 Mar 2024
- Last updated
- 22 Mar 2024
- 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 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the GCF Periostin, IL-17A and IL-17E Levels of Smoking and Non-smoking Periodontitis Patients Received Periodontal Treatment: Short-term Follow-up Study
- ClinicalTrials.gov ID
- NCT06326073
- Acronym / sponsor ID
- OMUKAEK2019/324
- Conditions
- Periodontitis, Smoking
- Keywords
- non surgical periodontal therapy, smoking, periostin, IL-17, gingival crevicular fluid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 22 Mar 2024 (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.
It was aimed to evaluate the changes in the levels of Periostin, IL-17A and IL-17E cytokines in the gingival crevicular fluid (GCF) of periodontitis patients which non-surgical (Phase I) periodontal treatment applied to and their interactions with smoking. The study included systemic healthy smokers(SP)(n:11) and non-smokers(P)(n:11) with periodontitis, smokers (SS)(n:11) and non-smokers(S)(n:11) with periodontal healthy individuals Phase I periodontal treatment was applied to the groups with periodontitis. Before treatment (day 0), clinical measurements evaluating periodontal status were recorded and GCF samples were collected. GCF samples were collected from the same tooth regions on the 15th and 30th days after treatment and clinical measurements were repeated. GCF Periostin, IL-17A and IL-17E levels were determined by ELISA method. All data were evaluated statistically.
Detailed description
The SH and H groups' patients were instructed to visit for routine controls without receiving any periodontal treatment. However, after the GCF sampling, patients in the SP and P groups received Non-surgical periodontal treatment(NSPT) included detailed oral hygiene instruction and reinforcement in conjunction with scaling and root planning as a full mouth debridement protocol in a single session They were instructed to refrain from using any chemicals, including mouthwash, to remove plaque.
The periodontitis patients received a follow-up call on the 15th and 30th days following treatment. The GCF sampling procedure was first repeated on the teeth from which a previous GCF sample had been taken. Then, values for the clinical examination parameters (PI, GI, BOP, PD, and CAL) were once again measured and recorded. Daily plaque care efficacy or deficiency was checked and/or reinforced at every recall. All these procedures were performed by a single investigator.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- The study included systemic healthy smokers(SP)(n:11) and non-smokers(P)(n:11) with periodontitis, smokers (SH)(n:11) and non-smokers(H)(n:11) with periodontal healthy individuals
| Arm | Type | Receives |
|---|---|---|
| Group I: SP | Experimental | Procedure: Non Surgical Periodontal Treatmentsmokers with periodontitis |
| Group II: P | Experimental | Procedure: Non Surgical Periodontal Treatmentnon-smokers with periodontitis |
| Group III: SH | No intervention | –smokers with periodontal healthy individuals |
| Group IV: H | No intervention | –non-smokers with periodontal healthy individuals |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- generalized stage 3 periodontitis or periodontally healthy;
- smoker ((≥10 cigarettes/day for >5 years) or nonsmoker (never smoked in their lifetime);
- not have received any periodontal treatment in the last 6 months, took any antibiotics, anti-inflammatory drugs regularly and for female subjects, not to be pregnant, lactating, or menopause.
Key exclusion criteria (8 listed)
- Under 18 years of age
- Those with a systemic disease
- Cancer patients, those with a history of chemotherapy and radiotherapy
- Pregnant and breastfeeding women
- Those who smoke less than 10 cigarettes a day and those who quit smoking
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 TreatmentPhase 1 periodontal (full mouth debridement) treatment was applied to groups with periodontitis in one session. | Procedure or surgery | Group I: SP, Group II: P |
Primary outcome
Evaluation of Periostin levels
Time frame: 0-15-30 days
The effect of non-surgical periodontal treatment in gingival crevicular fluid periostin levels
Evaluation of IL-17A levels
Time frame: 0-15-30 days
The effect of non-surgical periodontal treatment in gingival crevicular fluid IL-17A levels
Evaluation of IL-17E levels
Time frame: 0-15-30 days
The effect of non-surgical periodontal treatment in gingival crevicular fluid IL-17E levels
1 secondary outcome
Interaction Between Smoking and GCF Periostin, IL17A, IL17E levels
Time frame: 0-15-30 days
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 22 Mar 2024.
- 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.
Muge Luftioglu study director
Ondokuz Mayıs Universitesi
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 in people with Periodontitis and Smoking, run by Ondokuz Mayıs 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 3 inclusion and 8 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 22 Mar 2024. 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. 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?
Evaluation of Periostin levels (time frame: 0-15-30 days). The study lists 3 primary outcomes in all. 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 22 Mar 2024.