Periodontal DiseasesPhase 2NCT02066337
Effect of Ozone Gel on Treatment of Chronic Periodontitis
A Phase 2 study testing scaling and root planing and Ozonated olive oil gel in people with Periodontal Diseases, run by October 6 University at 1 site in Egypt.
Trial summary
To evaluate the efficacy of locally delivered ozone gel as an adjunct to conventional periodontal therapy on selected clinical parameters as well as alveolar bone density (BD) and superoxide dismutase (SOD) activity in patient with chronic periodontitis. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- scaling and root planing and Ozonated olive oil gel
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2013to Feb 2014
- Phase
- Phase 2
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- The participant's age ranged between 30 and 60 years.
- All of the patients suffered from chronic periodontitis with attachment loss ≥ 5mm.
- Willingness to participate and sign the informed consent.
Who cannot join
- Any systemic disease that affect the periodontium.
- Pregnancy, lactation, postmenopausal women
- People who take anti-inflammatory drugs, antibiotics or vitamins within the previous 3 month.
- People who use mouth washes regularly
- Heavy smoking (> 10 cigarettes/day)
- History of alcohol abuse.
- Participation in other clinical trials.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Ozone Gel on Alveolar Bone Density and Superoxide Dismutase in Chronic Periodontitis: A Randomized Controlled Clinical Study
To evaluate the efficacy of locally delivered ozone gel as an adjunct to conventional periodontal therapy on selected clinical parameters as well as alveolar bone density (BD) and superoxide dismutase (SOD) activity in patient with chronic periodontitis.
Read the detailed description
In this study, the investigators tested the effect of ozone gel as a local delivery system in treatment of chronic periodontitis in term of probing pocket depth reduction, mean gain in clinical attachment level, a more rise in BD values as well as greater reduction in SOD activity compared to scaling and root planing (SRP) alone.
- Conditions
- Periodontal Diseases
- Being tested
- scaling and root planing, placebo gel, Ozonated olive oil gel
- Keywords
- Ozone gel, Antioxidants, Chronic periodontitis, Superoxide dismutase
- Medical subject headings
- Periodontal Diseases, Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
scaling and root planingProcedure or surgery
placebo gelDrug
Ozonated olive oil gelDrug
Also called Ozonated olive oil gel = Oxactiv gel
| Study group | Role | What they receive |
|---|---|---|
| placebo gel | Placebo comparator | scaling and root planing with placebo gel Receives: Procedure: scaling and root planing; Drug: placebo gel |
| Ozonated olive oil gel | Active comparator | scaling and root planing with Ozonated olive oil gel Receives: Procedure: scaling and root planing; Drug: Ozonated olive oil gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Superoxide dismutase activity
Superoxide dismutase activity in the gingival crevicular fluid was carried out at baseline, 1, 3 and 6 months post treatment.
Measured: 6 months
Secondary outcomes (5)
Plaque Index
plaque index was recorded at baseline and at 1, 3 and 6 months post treatment.
Measured: 6 months
Gingival index
Gingival index was recorded at base line,1,3,6 months post treatment
Measured: 6 months
Probing pocket depth
Probing pocket depth was recorded at base line, 1, 3, 6 months post treatment
Measured: 6 months
Clinical attachment level
Clinical attachment level was recorded at baseline, 1, 3 and 6 months post treatment
Measured: 6 months
Bone density
Bone density was carried out using Digora software (Digora system, Soredex, Orion Corp., Finland) at baseline and 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2014 (estimated)
- Study startMar 2013
- Primary completionJan 2014
- Study completionFeb 2014
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enas Elgendy, October 6 University
- Investigators
- Enas Elgendy, ph.D, Principal investigator, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02066337
- Sponsor's protocol ID
- mn1965
- Status last verified
- Feb 2014
- First submitted
- 30 Jan 2014
- Last updated
- 20 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ozone Gel on Alveolar Bone Density and Superoxide Dismutase in Chronic Periodontitis: A Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT02066337
- Acronym / sponsor ID
- mn1965
- Conditions
- Periodontal Diseases
- Keywords
- Ozone gel, Antioxidants, Chronic periodontitis, Superoxide dismutase
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 19 Feb 2014 (estimated)
- 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.
To evaluate the efficacy of locally delivered ozone gel as an adjunct to conventional periodontal therapy on selected clinical parameters as well as alveolar bone density (BD) and superoxide dismutase (SOD) activity in patient with chronic periodontitis.
Detailed description
In this study, the investigators tested the effect of ozone gel as a local delivery system in treatment of chronic periodontitis in term of probing pocket depth reduction, mean gain in clinical attachment level, a more rise in BD values as well as greater reduction in SOD activity compared to scaling and root planing (SRP) alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo gel | Placebo comparator | Procedure: scaling and root planing, Drug: placebo gelscaling and root planing with placebo gel |
| Ozonated olive oil gel | Active comparator | Procedure: scaling and root planing, Drug: Ozonated olive oil gelscaling and root planing with Ozonated olive oil gel |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- The participant's age ranged between 30 and 60 years.
- All of the patients suffered from chronic periodontitis with attachment loss ≥ 5mm.
- Willingness to participate and sign the informed consent.
Key exclusion criteria (7 listed)
- Any systemic disease that affect the periodontium.
- Pregnancy, lactation, postmenopausal women
- People who take anti-inflammatory drugs, antibiotics or vitamins within the previous 3 month.
- People who use mouth washes regularly
- Heavy smoking (> 10 cigarettes/day)
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 |
|---|---|---|
| scaling and root planing | Procedure or surgery | Ozonated olive oil gel, placebo gel |
| placebo gel | Drug | placebo gel |
| Ozonated olive oil gelAlso: Ozonated olive oil gel = Oxactiv gel | Drug | Ozonated olive oil gel |
Primary outcome
Superoxide dismutase activity
Time frame: 6 months
Superoxide dismutase activity in the gingival crevicular fluid was carried out at baseline, 1, 3 and 6 months post treatment.
5 secondary outcomes
Plaque Index
Time frame: 6 months
Gingival index
Time frame: 6 months
Probing pocket depth
Time frame: 6 months
Clinical attachment level
Time frame: 6 months
Bone density
Time frame: 6 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 20 Feb 2014.
Related trials for Periodontal Diseases
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Recruiting
Thermosensitive Hyaluronic Gel With Octenidine as an Adjunctive to Subgingival Instrumentation
Periodontal Disease
Active, not recruitingObservational study
A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
Periodontitis
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Recruiting
Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
Ozone Gel, Chlorohexidine Gel
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.
Enas Elgendy, ph.D principal investigator
October 6 University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing scaling and root planing and Ozonated olive oil gel in people with Periodontal Diseases, run by October 6 University at 1 site in Egypt.
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 7 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 20 Feb 2014. 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 Egypt. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Superoxide dismutase activity (time frame: 6 months). 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 20 Feb 2014.