Periodontal PocketPhase 1NCT05905445
Use of Ozone Gel as an Antimicrobial in Treatment of Periodontitis
A Phase 1 study testing ozone gel in people with Periodontal Pocket and Periodontitis, run by Ghufran Falih Hassan at 1 site in Iraq.
Trial summary
Periodontitis is an inflammatory disease that destroys tooth-supporting structures through oral bacterial plaque. ozone gel's act as an antimicrobial effect as an adjunct to conventional periodontal therapy (scaling and root planning). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Periodontal Pocket, Periodontitis
- What is being tested?
- ozone gel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteIraq
- Study dates
- 9 Mar 2022to 9 Sep 2022
- Phase
- Phase 1
- 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
- The patient should be systemically healthy
- The patient has periodontitis equal to or more than two non-adjacent teeth, with probing pocket depth equal to or more than 4mm.
- Patients capable of following orders and motivation
Who cannot join
- Patients with removable dentures who undergo orthodontic therapy.
- Patients with teeth suffer from endo-periodontal lesions.
- Patients have three months of using anti-inflammatory medications, antibiotics, immune suppressants, or oral contraceptives.
- Patients having systemic conditions that affect the condition.
- Pregnant or nursing mothers.
- Patients who are smokers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Ozone Gel as an Adjunct Treatment in Patients of Periodontitis According to Clinical and Biological Marker. A Split-mouth Randomized Controlled Clinical Trial.
Periodontitis is an inflammatory disease that destroys tooth-supporting structures through oral bacterial plaque. ozone gel's act as an antimicrobial effect as an adjunct to conventional periodontal therapy (scaling and root planning). exposure of bacteria to ozone leads to the oxidation of the phospholipids and lipoproteins that comprise the bacterial cell membrane. Ozone gel has the potential to play an anti-inflammatory role in the treatment of periodontitis by monitoring both clinical and biological parameters.
Read the detailed description
Periodontitis is an inflammatory disease that destroys tooth-supporting structures through oral bacterial plaque. Scaling and root planning are considered the gold standard treatment for periodontal disease. Antiseptics represent an aid to the gold standard nonsurgical treatment of scaling and root planning (SRP) for periodontal disease. Adjuncts to scaling and root planning have been introduced as ozone gel. This gel represents both antimicrobial and beneficial effects while expressing safe cytocompatibility toward host tissues, which is progressively developing.
The study aims to determine ozone gel's antimicrobial effect as an adjunct to conventional periodontal therapy (scaling and root planning).
Material and Methods: Twenty-one patients with periodontitis were enrolled in this study. There were 58 periodontal pockets divided into two groups by a blinded split-mouth design. The control group had 28 periodontal pockets treated with scaling and root planning only, while the test group had 30 with scaling and root planning and ozone gel. Two gel applications were applied at baseline and one month after the treatment. Plaque index, bleeding on probing, probing pocket depth, and relative attachment level were recorded. Gingival crevicular fluid samples were collected from the pockets at each site for both groups at different time intervals. The GCF sample was transferred into Eppendorf tubes containing 1.5 ml of PBS buffer, and the samples were stored in a freezer at -40˚C.
- Conditions
- Periodontal Pocket, Periodontitis
- Being tested
- ozone gel
- Medical subject headings
- Periodontal Pocket, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ozone gelDrug
the activity of omega-3 in the ozone gel may be advantageous as a host-modulating agent in the supplemental treatment of periodontitis
| Study group | Role | What they receive |
|---|---|---|
| ozone gel with conventional scaling and root planning | Experimental | administered ozone gel in the probing pocket depth after scaling and root planning by a disposable plastic syringe with a blunt tip until the access ozone became out of the pocket. this procedure is made at baseline and in the first month. instructed the patient not to eat or drink for at least 30 minutes Receives: Drug: ozone gel |
| only conventional scaling and root planning | No intervention | only scaling and root planning without any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
probing pocket depth
change of probing pocket depth by ozone gel as an adjunct to non-surgical treatment
Measured: baseline to one and three months
Secondary outcomes (4)
plaque index
change in presence plaque (used disclosing agent) by ozone gel as an adjunct to non-surgical treatment
Measured: baseline to one and three months
bleeding on probing
change in presence bleeding on probing (used UNC 15 probe) by ozone gel as an adjunct to non-surgical treatment
Measured: baseline to one and three months
clinical attachment loss
change in presence clinical attachment loss (Used relative attachment stent) by ozone gel as an adjunct to non-surgical treatment
Measured: baseline to one and three months
level of platelet-activating factor in gingival crevicular fluid
change in level of platelet-activating factor in gingival crevicular fluid (Used ELISA kit to measurement level of PAF in gingival crevicular fluid) by ozone gel as an adjunct to non-surgical treatment
Measured: baseline to one and three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start9 Mar 2022
- Primary completion9 Sep 2022
- Study completion9 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Periodontal PocketStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ghufran Falih Hassan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ghufran Falih Hassan, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05905445
- Sponsor's protocol ID
- Ozone gel in periodontitis
- Status last verified
- Jun 2023
- First submitted
- 26 May 2023
- Last updated
- 15 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Colombo M, Gallo S, Garofoli A, Poggio C, Arciola CR, Scribante A. Ozone Gel in Chronic Periodontal Disease: A Randomized Clinical Trial on the Anti-Inflammatory Effects of Ozone Application. Biology (Basel). 2021 Jul 6;10(7):625. doi: 10.3390/biology10070625.
PubMed 34356480
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ozone Gel as an Adjunct Treatment in Patients of Periodontitis According to Clinical and Biological Marker. A Split-mouth Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT05905445
- Acronym / sponsor ID
- Ozone gel in periodontitis
- Conditions
- Periodontal Pocket, Periodontitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Ghufran Falih HassanUniversity, hospital or other
- Study start
- 9 Mar 2022 (actual)
- Primary completion
- 9 Sep 2022 (actual)
- Study completion
- 9 Sep 2022 (actual)
- First posted
- 15 Jun 2023 (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.
Periodontitis is an inflammatory disease that destroys tooth-supporting structures through oral bacterial plaque. ozone gel's act as an antimicrobial effect as an adjunct to conventional periodontal therapy (scaling and root planning). exposure of bacteria to ozone leads to the oxidation of the phospholipids and lipoproteins that comprise the bacterial cell membrane. Ozone gel has the potential to play an anti-inflammatory role in the treatment of periodontitis by monitoring both clinical and biological parameters.
Detailed description
Periodontitis is an inflammatory disease that destroys tooth-supporting structures through oral bacterial plaque. Scaling and root planning are considered the gold standard treatment for periodontal disease. Antiseptics represent an aid to the gold standard nonsurgical treatment of scaling and root planning (SRP) for periodontal disease. Adjuncts to scaling and root planning have been introduced as ozone gel. This gel represents both antimicrobial and beneficial effects while expressing safe cytocompatibility toward host tissues, which is progressively developing.
The study aims to determine ozone gel's antimicrobial effect as an adjunct to conventional periodontal therapy (scaling and root planning).
Material and Methods: Twenty-one patients with periodontitis were enrolled in this study. There were 58 periodontal pockets divided into two groups by a blinded split-mouth design. The control group had 28 periodontal pockets treated with scaling and root planning only, while the test group had 30 with scaling and root planning and ozone gel. Two gel applications were applied at baseline and one month after the treatment. Plaque index, bleeding on probing, probing pocket depth, and relative attachment level were recorded. Gingival crevicular fluid samples were collected from the pockets at each site for both groups at different time intervals. The GCF sample was transferred into Eppendorf tubes containing 1.5 ml of PBS buffer, and the samples were stored in a freezer at -40˚C.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ozone gel with conventional scaling and root planning | Experimental | Drug: ozone geladministered ozone gel in the probing pocket depth after scaling and root planning by a disposable plastic syringe with a blunt tip until the access ozone became out of the pocket. this procedure is made at baseline and in the first month. instructed the patient not to eat or drink for at least 30 minutes |
| only conventional scaling and root planning | No intervention | –only scaling and root planning without any intervention. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- The patient should be systemically healthy
- The patient has periodontitis equal to or more than two non-adjacent teeth, with probing pocket depth equal to or more than 4mm.
- Patients capable of following orders and motivation
Key exclusion criteria (6 listed)
- Patients with removable dentures who undergo orthodontic therapy.
- Patients with teeth suffer from endo-periodontal lesions.
- Patients have three months of using anti-inflammatory medications, antibiotics, immune suppressants, or oral contraceptives.
- Patients having systemic conditions that affect the condition.
- Pregnant or nursing mothers.
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 |
|---|---|---|
| ozone gelthe activity of omega-3 in the ozone gel may be advantageous as a host-modulating agent in the supplemental treatment of periodontitis | Drug | ozone gel with conventional scaling and root planning |
Primary outcome
probing pocket depth
Time frame: baseline to one and three months
change of probing pocket depth by ozone gel as an adjunct to non-surgical treatment
4 secondary outcomes
plaque index
Time frame: baseline to one and three months
bleeding on probing
Time frame: baseline to one and three months
clinical attachment loss
Time frame: baseline to one and three months
level of platelet-activating factor in gingival crevicular fluid
Time frame: baseline to one and three months
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 Jun 2023.
- Background: PubMed 34356480Colombo M, Gallo S, Garofoli A, Poggio C, Arciola CR, Scribante A. Ozone Gel in Chronic Periodontal Disease: A Randomized Clinical Trial on the Anti-Inflammatory Effects of Ozone Application. Biology (Basel). 2021 Jul 6;10(7):625. doi: 10.3390/biology10070625.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ozone gel in people with Periodontal Pocket and Periodontitis, run by Ghufran Falih Hassan at 1 site in Iraq.
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 6 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 Jun 2023. 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 Iraq. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
probing pocket depth (time frame: baseline to one and three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05905445, which also lists 1 linked publication.
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 Jun 2023.