Chronic PeriodontitisNCT03874390
Effects of Ozone Therapy on Clinical Parameters and Inflammatory Cytokines in Chronic Periodontitis Patients
A study testing ozone in people with Chronic Periodontitis, run by Ataturk University.
Trial summary
The objective of this study is to evaluate of ozone therapy on both clinical and biochemical effects in periodontally patients. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- ozone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Feb 2016
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- systemically healthy
- non-smokers
- chronic periodontitis participants
Who cannot join
- smokers
- pregnancy or lactation
- individiuals with any systemic disease
About this study
Official title: Effects of Ozone Therapy Adjunct to Initial Periodontal Therapy on Clinical Parameters and Inflammatory Cytokines in Chronic Periodontitis Patients
The objective of this study is to evaluate of ozone therapy on both clinical and biochemical effects in periodontally patients.
Read the detailed description
This study is evaluated clinical and biochemical effect of ozone therapy at 8 weeks in periodontitis patients.
- Conditions
- Chronic Periodontitis
- Being tested
- ozone
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ozoneOther
gaseous ozone was applied on periodontal pocket two times in one week.
| Study group | Role | What they receive |
|---|---|---|
| ozone therapy | Experimental | control group only treated with Initial Periodontal Therapy (IPT), test group treated with IPT an adjunct to gasesos ozone therapy. Receives: Other: ozone |
| initially periodontal therapy | Active comparator | control group only treated with Initial Periodontal Therapy (IPT), test group treated with IPT an adjunct to gasesos ozone therapy. Receives: Other: ozone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical atachment level baseline
Calculation as distance in millimeters from cement-enamel junction to the bottom of the pocket by Williams periodontal probe
Measured: baseline (before treatment)
Plaque index baseline
As described by Silness\&Löe 1964; The measurement of the state of oral hygiene by Silness-Löe plaque index is based on recording both soft debris and mineralized deposits on the following teeth. Each of the four surfaces of the teeth (buccal, lingual, mesial and distal) is given a score from 0-3.
Scores 0: No plaque. scores 1: A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface.
scores 2: Moderate accumulation of soft deposit s within the gingival pocket, or the tooth and gingival margin which can be seen with the naked eye.
scores 3: Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.
score 0 considered good oral hygiene, score 3 bad oral hygiene habits. plaque index for a tooth=scores from 4 areas/4 plaque index individiual= scores from 28 tooth/28
Measured: baseline (before treatment)
Gingival index baseline
As described by Löe\&Silness 1963; The bleeding is assessed by probing gently along the wall of soft tissue of the gingival sulcus. Each of the four surfaces of the teeth (buccal, lingual, mesial and distal) is given a score from 0-3.
score 0 - Normal, healthy gingival with sharp, non-inflamed margins. score 1 - Marginal gingivitis with minimal inflammation and edema at the free gingival. No bleeding on probing.
score 2 - Moderate gingivitis with a wider band of inflammation and bleeding upon probing.
score 3 - Advanced gingivitis with inflammation clinically reaching the mucogingival junction usually with ulceration.
score 0 considered healty gingiva, score 3 assesed advanced gingival disease. gingival index for a tooth=scores from 4 areas/4 gingival index individiual= scores from 28 tooth/28
Measured: baseline (before treatment)
Bleeding on probing baseline
As described by Ainamo\&Bay 1975; The index is performed through gentle probing of the orifice of the gingival crevice. If bleeding occurs within 10 seconds a positive finding is recorded and the number of positive sites is recorded and then expressed as a percentage of the number of sites examined.
bleeding present (+) absent (-) bleeding surface/all surface *100=% bleeding absent recording is equivalent to gingival index scores 0\&1. bleeding present recording is equivalent to gingival index score 2\&3.
- 0: no bleeding on probing, healty gingiva
- 100: all gingiva bleeding on probing; diseased gingiva.
Measured: baseline (before treatment)
Probing of depth baseline
Measurement to the nearest millimeter from the gingival margin to the base of the clinical pocket by Williams periodontal probe
Measured: baseline (before treatment)
Biochemical outcomes baseline
In this study, biochemical parametres including IL-1B, IL-6, IL-10, TNF-a, MMP-9 were measured (pg/ml) by ELISA (Enzyme-Linked Immuno Sorbent Assay) measured (pg/ml) by ELISA (Enzyme-Linked Immuno Sorbent Assay) methods on Gingival Crevicular Fluid at baseline.
Measured: baseline (before treatment)
Secondary outcomes (6)
Clinical attachment level after 8 weeks
Calculation as distance in millimeters from cement-enamel junction to the bottom of the pocket by Williams periodontal probe
Measured: 8 weeks after treatment
Plaque index after 8 weeks
As described by Silness\&Löe 1964; The measurement of the state of oral hygiene by Silness-Löe plaque index is based on recording both soft debris and mineralized deposits on the following teeth. Each of the four surfaces of the teeth (buccal, lingual, mesial and distal) is given a score from 0-3.
Scores 0: No plaque scores 1: A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface.
scores 2: Moderate accumulation of soft deposit s within the gingival pocket, or the tooth and gingival margin which can be seen with the naked eye.
scores 3: Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.
score 0 considered good oral hygiene, score 3 bad oral hygiene habits. plaque index for a tooth=scores from 4 areas/4 plaque index individiual= scores from 28 tooth/28
Measured: 8 weeks after treatment
Gingival index after 8 weeks
As described by Löe\&Silness 1963; The bleeding is assessed by probing gently along the wall of soft tissue of the gingival sulcus. Each of the four surfaces of the teeth (buccal, lingual, mesial and distal) is given a score from 0-3.
score 0 - Normal, healthy gingival with sharp, non-inflamed margins. score 1 - Marginal gingivitis with minimal inflammation and edema at the free gingival. No bleeding on probing.
score 2 - Moderate gingivitis with a wider band of inflammation and bleeding upon probing.
score 3 - Advanced gingivitis with inflammation clinically reaching the mucogingival junction usually with ulceration. score 0 considered healty gingiva, score 3 assesed advanced gingival disease.
gingival index for a tooth=scores from 4 areas/4 gingival index individiual= scores from 28 tooth/28
Measured: 8 weeks after tretament
Bleeding on probing after 8 weeks
As described by Ainamo\&Bay 1975; the index is performed through gentle probing of the orifice of the gingival crevice. If bleeding occurs within 10 seconds a positive finding is recorded and the number of positive sites is recorded and then expressed as a percentage of the number of sites examined.
bleeding present (+) absent (-) bleeding surface/all surface *100=% bleeding absent recording is equivalent to gingival index scores 0\&1. bleeding present recording is equivalent to gingival index score 2\&3.
- 0: no bleeding on probing, healty gingiva
- 100: all gingiva bleeding on probing; diseased gingiva.
Measured: 8 weeks after treatment
Probing of dept after 8 weeks
Measurement to the nearest millimeter from the gingival margin to the base of the clinical pocket by Williams periodontal probe
Measured: 8 weeks after tretament
Biochemical outcomes after 8 weeks
In this study, biochemical parametres including IL-1B, IL-6, IL-10, TNF-a, MMP-9 were measured (pg/ml) by ELISA (Enzyme-Linked Immuno Sorbent Assay) measured (pg/ml) by ELISA (Enzyme-Linked Immuno Sorbent Assay) methods on Gingival Crevicular Fluid at 8 weeks
Measured: 8 weeks after tretment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2019
- Study startOct 2014
- Primary completionOct 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PeriodontitisStudies of the same condition, open and under way.
- More trials run by Ataturk 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sema Nur Sevinc, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03874390
- Sponsor's protocol ID
- 60078
- Status last verified
- Mar 2019
- First submitted
- 1 May 2016
- Last updated
- 15 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ozone Therapy Adjunct to Initial Periodontal Therapy on Clinical Parameters and Inflammatory Cytokines in Chronic Periodontitis Patients
- ClinicalTrials.gov ID
- NCT03874390
- Acronym / sponsor ID
- 60078
- Conditions
- Chronic Periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 14 Mar 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 objective of this study is to evaluate of ozone therapy on both clinical and biochemical effects in periodontally patients.
Detailed description
This study is evaluated clinical and biochemical effect of ozone therapy at 8 weeks in periodontitis patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ozone therapy | Experimental | Other: ozonecontrol group only treated with Initial Periodontal Therapy (IPT), test group treated with IPT an adjunct to gasesos ozone therapy. |
| initially periodontal therapy | Active comparator | Other: ozonecontrol group only treated with Initial Periodontal Therapy (IPT), test group treated with IPT an adjunct to gasesos ozone therapy. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- systemically healthy
- non-smokers
- chronic periodontitis participants
Key exclusion criteria (3 listed)
- smokers
- pregnancy or lactation
- individiuals with any systemic disease
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 |
|---|---|---|
| ozonegaseous ozone was applied on periodontal pocket two times in one week. | Other | initially periodontal therapy, ozone therapy |
Primary outcome
Clinical atachment level baseline
Time frame: baseline (before treatment)
Calculation as distance in millimeters from cement-enamel junction to the bottom of the pocket by Williams periodontal probe
Plaque index baseline
Time frame: baseline (before treatment)
As described by Silness\&Löe 1964; The measurement of the state of oral hygiene by Silness-Löe plaque index is based on recording both soft debris and mineralized deposits on the following teeth. Each of the four surfaces of the teeth (buccal, lingual, mesial and distal) is given a score from 0-3. Scores 0: No plaque. scores 1: A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface. scores 2: Moderate accumulation of soft deposit s within the gingival pocket, or the tooth and gingival margin which can be seen with the naked eye. scores 3: Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin. score 0 considered good oral hygiene, score 3 bad oral hygiene habits. plaque index for a tooth=scores from 4 areas/4 plaque index individiual= scores from 28 tooth/28
Gingival index baseline
Time frame: baseline (before treatment)
As described by Löe\&Silness 1963; The bleeding is assessed by probing gently along the wall of soft tissue of the gingival sulcus. Each of the four surfaces of the teeth (buccal, lingual, mesial and distal) is given a score from 0-3. score 0 - Normal, healthy gingival with sharp, non-inflamed margins. score 1 - Marginal gingivitis with minimal inflammation and edema at the free gingival. No bleeding on probing. score 2 - Moderate gingivitis with a wider band of inflammation and bleeding upon probing. score 3 - Advanced gingivitis with inflammation clinically reaching the mucogingival junction usually with ulceration. score 0 considered healty gingiva, score 3 assesed advanced gingival disease. gingival index for a tooth=scores from 4 areas/4 gingival index individiual= scores from 28 tooth/28
Bleeding on probing baseline
Time frame: baseline (before treatment)
As described by Ainamo\&Bay 1975; The index is performed through gentle probing of the orifice of the gingival crevice. If bleeding occurs within 10 seconds a positive finding is recorded and the number of positive sites is recorded and then expressed as a percentage of the number of sites examined. bleeding present (+) absent (-) bleeding surface/all surface *100=% bleeding absent recording is equivalent to gingival index scores 0\&1. bleeding present recording is equivalent to gingival index score 2\&3. * 0: no bleeding on probing, healty gingiva * 100: all gingiva bleeding on probing; diseased gingiva.
Probing of depth baseline
Time frame: baseline (before treatment)
Measurement to the nearest millimeter from the gingival margin to the base of the clinical pocket by Williams periodontal probe
Biochemical outcomes baseline
Time frame: baseline (before treatment)
In this study, biochemical parametres including IL-1B, IL-6, IL-10, TNF-a, MMP-9 were measured (pg/ml) by ELISA (Enzyme-Linked Immuno Sorbent Assay) measured (pg/ml) by ELISA (Enzyme-Linked Immuno Sorbent Assay) methods on Gingival Crevicular Fluid at baseline.
6 secondary outcomes
Clinical attachment level after 8 weeks
Time frame: 8 weeks after treatment
Plaque index after 8 weeks
Time frame: 8 weeks after treatment
Gingival index after 8 weeks
Time frame: 8 weeks after tretament
Bleeding on probing after 8 weeks
Time frame: 8 weeks after treatment
Probing of dept after 8 weeks
Time frame: 8 weeks after tretament
Biochemical outcomes after 8 weeks
Time frame: 8 weeks after tretment
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 15 Mar 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.
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 ozone in people with Chronic Periodontitis, run by Ataturk 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 3 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 15 Mar 2019. 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?
Clinical atachment level baseline (time frame: baseline (before treatment)). The study lists 6 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 15 Mar 2019.