Periodontal DiseasePhase 3NCT07861880
Comparative Evaluation of Oxygen-enriched and Chlorohexidine Mouthwashes as an Adjunct to Non-surgical Periodontal Therapy and Its Efficacy on Gingival Inflammation, Plaque Scores and Patient-reported Outcomes
A Phase 3 study testing CHX mouthwash and Oxygen-enriched mouthwash in people with Periodontal Disease and Periodontal Diseases Inflammation, run by Cairo University at 1 site in Egypt.
Trial summary
comparison between CHX and oxygen-enriched mouthwash Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Periodontal Disease, Periodontal Diseases Inflammation, Gingivitis
- What is being tested?
- CHX mouthwash and Oxygen-enriched mouthwash
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2025to 15 Apr 2026
- Phase
- Phase 3
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- systemically healthy and diagnosed with dental biofilm-induced gingivitis
Who cannot join
- . Less than 20 teeth remaining.
- Patients who had undergone any periodontal therapy in the last 6 months
- Tobacco smokers
- Known systemic disease.
- Pregnant or lactating females
- Use of antibiotic or anti-inflammatory medications in the last 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Evaluation of Oxygen-Enriched and Chlorohexidine Mouthwashes as an Adjunct to Non-Surgical Periodontal Therapy and Its Efficacy on Gingival Inflammation, Plaque Scores and Patient-Reported Outcomes
comparison between CHX and oxygen-enriched mouthwash
Read the detailed description
compare the effect of oxygen-enriched versus CHX mouthwashes on plaque index (PI) and bleeding on probing (BoP), with the possible adverse effects.
- Being tested
- CHX mouthwash, Oxygen-enriched mouthwash
- Keywords
- mouthwash, anti-plaque, oxygenated mouthwash, gingivitis
- Medical subject headings
- Periodontal Diseases, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHX mouthwashDrug
Also called chlorohexidine
Patient uses mouthwash 30 minutes after tooth brushing
Oxygen-enriched mouthwashDrug
Also called oxygenated mouthwash
patient uses oxygenated mouthwash 30 minutes after tooth brushing
| Study group | Role | What they receive |
|---|---|---|
| gingivitis patients using CHX after Step 1 periodontal therapy | Active comparator | gingivitis patients using CHX after Step 1 periodontal therapy Receives: Drug: CHX mouthwash |
| gingivitis patients using oxygenated mouthwash after Step 1 periodontal therapy | Experimental | gingivitis patients using oxygenated mouthwash after Step 1 periodontal therapy Receives: Drug: Oxygen-enriched mouthwash |
| gingivitis patients using no mouthwash after Step 1 periodontal therapy | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque index
Measured: 3 weeks
Secondary outcomes (2)
Gingival index (Bleeding on probing (BoP))
Measured: 3 weeks
Patient-reported outcomes
patients report adverse effects (teeth and tongue staining, burning sensation, taste alterations and oral dryness)on a scale from 1-10, where 1 is the minimum adverse effect, and 10 is the maximum.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start1 Dec 2025
- Primary completion25 Mar 2026
- Study completion15 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseaseStudies of the same condition, open and under way.
- More trials run by Cairo 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Azza Mohamed Nasr, NewGiza University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07861880
- Sponsor's protocol ID
- CEBD-CU-2025-10-28
- Status last verified
- Oct 2026
- First submitted
- 30 Sep 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Oxygen-Enriched and Chlorohexidine Mouthwashes as an Adjunct to Non-Surgical Periodontal Therapy and Its Efficacy on Gingival Inflammation, Plaque Scores and Patient-Reported Outcomes
- ClinicalTrials.gov ID
- NCT07861880
- Acronym / sponsor ID
- CEBD-CU-2025-10-28
- Keywords
- mouthwash, anti-plaque, oxygenated mouthwash, gingivitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 25 Mar 2026 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 6 Oct 2026 (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.
comparison between CHX and oxygen-enriched mouthwash
Detailed description
compare the effect of oxygen-enriched versus CHX mouthwashes on plaque index (PI) and bleeding on probing (BoP), with the possible adverse effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| gingivitis patients using CHX after Step 1 periodontal therapy | Active comparator | Drug: CHX mouthwashgingivitis patients using CHX after Step 1 periodontal therapy |
| gingivitis patients using oxygenated mouthwash after Step 1 periodontal therapy | Experimental | Drug: Oxygen-enriched mouthwashgingivitis patients using oxygenated mouthwash after Step 1 periodontal therapy |
| gingivitis patients using no mouthwash after Step 1 periodontal therapy | No intervention | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- systemically healthy and diagnosed with dental biofilm-induced gingivitis
Key exclusion criteria (6 listed)
- . Less than 20 teeth remaining.
- Patients who had undergone any periodontal therapy in the last 6 months
- Tobacco smokers
- Known systemic disease.
- Pregnant or lactating females
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 |
|---|---|---|
| CHX mouthwashAlso: chlorohexidinePatient uses mouthwash 30 minutes after tooth brushing | Drug | gingivitis patients using CHX after Step 1 periodontal therapy |
| Oxygen-enriched mouthwashAlso: oxygenated mouthwashpatient uses oxygenated mouthwash 30 minutes after tooth brushing | Drug | gingivitis patients using oxygenated mouthwash after Step 1 periodontal therapy |
Primary outcome
Plaque index
Time frame: 3 weeks
2 secondary outcomes
Gingival index (Bleeding on probing (BoP))
Time frame: 3 weeks
Patient-reported outcomes
Time frame: 3 weeks
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 6 Oct 2026.
- Individual participant dataSharing planned: Yes
Related trials for Periodontal Disease
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.
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 3 study testing CHX mouthwash and Oxygen-enriched mouthwash in people with Periodontal Disease and Periodontal Diseases Inflammation, run by Cairo 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 1 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 6 Oct 2026. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Plaque index (time frame: 3 weeks). 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 6 Oct 2026.