Denture StomatitisNCT06021847
Ozonated Water in Treatment of Denture Stomatitis
A study testing Ozonated water and Chlorhexidine mouthwash in people with Denture Stomatitis, run by National Research Centre, Egypt at 1 site in Egypt.
Trial summary
The effect of Ozonated water on the treatment of oral stomatitis associated with complete denture wearer in comparison to Chlorhexidine mouthwash Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Denture Stomatitis
- What is being tested?
- Ozonated water and Chlorhexidine mouthwash
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2023to 1 Jun 2023
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Completely edentulous male patients wearing heat cured acrylic resin removable prosthesis.
- Patients having denture associated oral stomatitis.
- Healthy patients free of any systemic diseases.
Who cannot join
- Smoker patients.
- Patients suffering from any auto immune or systemic diseases, Temporo-mandibular joint disorder ( TMJ disorders and parafunctional oral habits.
- Patients with a history of radiotherapy or chemotherapy.
- Patients having oral lesions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Ozone Water in Treatment of Denture Inflammation
The effect of Ozonated water on the treatment of oral stomatitis associated with complete denture wearer in comparison to Chlorhexidine mouthwash
Read the detailed description
Compete denture wearers having oral denture stomatitis were divided into two groups. group I used Ozonated water while group II used Chlorhexidine mouthwash. The growth of Candida albicans, the degree inflammation and pain grade were evaluated before starting the treatment then every week till one month. Also
- Conditions
- Denture Stomatitis
- Being tested
- Ozonated water, Chlorhexidine mouthwash
- Keywords
- Ozonated water, denture stomatitis, Chlorhexidine mouthwash
- Medical subject headings
- Stomatitis, Denture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ozonated waterOther
ozonated water was prepared with a concentration of (2-4 mg/l) ozone for 1 min. in a 25 mg of double distilled water 37o C employing an Ozone generator (Ozone generator type N 1888A, China.)
Chlorhexidine mouthwashOther
Commercial available chlorhexidine mouthwash in the market was used.
| Study group | Role | What they receive |
|---|---|---|
| Group I patients treated with ozonated water | Active comparator | The patients were used ozonated water as mouth wash for treatment of denture associated oral stomatitis. Receives: Other: Ozonated water |
| Group II patients treated with chlorhexidine mouthwash | Active comparator | The patients were used chlorhexidine mouth wash for treatment of denture associated oral stomatitis Receives: Other: Chlorhexidine mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Candida albicans colonies
The number of Candida albicans forming units (CFU) was used to assess the effect of two types of treatments.
Measured: day one, 7th day, 14th day and 30th day
Secondary outcomes (1)
-Evaluation of inflammation and pain grade
- Evaluation of inflammation and pain grade by questionnaire
Measured: day 1, and 30th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2023
- Study start1 May 2023
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Denture StomatitisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups ( complete denture wearers with oral stomatitis). Group I treated with ozonated water while group II treated with chlorhexidine mouthwash.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Research Centre, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Nabil Elboraey, National Research Centre, Egypt
- Investigators
- Asmaa N, Elboraey, Ass,Pro, Principal investigator, National Research Centre, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06021847
- Sponsor's protocol ID
- 4447082022
- Status last verified
- Jul 2022
- First submitted
- 27 Aug 2023
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ozone Water in Treatment of Denture Inflammation
- ClinicalTrials.gov ID
- NCT06021847
- Acronym / sponsor ID
- 4447082022
- Conditions
- Denture Stomatitis
- Keywords
- Ozonated water, denture stomatitis, Chlorhexidine mouthwash
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- National Research Centre, EgyptUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 1 Sep 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.
The effect of Ozonated water on the treatment of oral stomatitis associated with complete denture wearer in comparison to Chlorhexidine mouthwash
Detailed description
Compete denture wearers having oral denture stomatitis were divided into two groups. group I used Ozonated water while group II used Chlorhexidine mouthwash. The growth of Candida albicans, the degree inflammation and pain grade were evaluated before starting the treatment then every week till one month. Also
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Two groups ( complete denture wearers with oral stomatitis). Group I treated with ozonated water while group II treated with chlorhexidine mouthwash.
| Arm | Type | Receives |
|---|---|---|
| Group I patients treated with ozonated water | Active comparator | Other: Ozonated waterThe patients were used ozonated water as mouth wash for treatment of denture associated oral stomatitis. |
| Group II patients treated with chlorhexidine mouthwash | Active comparator | Other: Chlorhexidine mouthwashThe patients were used chlorhexidine mouth wash for treatment of denture associated oral stomatitis |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Completely edentulous male patients wearing heat cured acrylic resin removable prosthesis.
- Patients having denture associated oral stomatitis.
- Healthy patients free of any systemic diseases.
Key exclusion criteria (4 listed)
- Smoker patients.
- Patients suffering from any auto immune or systemic diseases, Temporo-mandibular joint disorder ( TMJ disorders and parafunctional oral habits.
- Patients with a history of radiotherapy or chemotherapy.
- Patients having oral lesions.
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 |
|---|---|---|
| Ozonated waterozonated water was prepared with a concentration of (2-4 mg/l) ozone for 1 min. in a 25 mg of double distilled water 37o C employing an Ozone generator (Ozone generator type N 1888A, China.) | Other | Group I patients treated with ozonated water |
| Chlorhexidine mouthwashCommercial available chlorhexidine mouthwash in the market was used. | Other | Group II patients treated with chlorhexidine mouthwash |
Primary outcome
Candida albicans colonies
Time frame: day one, 7th day, 14th day and 30th day
The number of Candida albicans forming units (CFU) was used to assess the effect of two types of treatments.
1 secondary outcome
-Evaluation of inflammation and pain grade
Time frame: day 1, and 30th day
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 1 Sep 2023.
- Individual participant dataSharing planned: No
Related trials for Denture Stomatitis
Not yet recruiting
Development of a Sanitizing Tablet for Removable Partial Dentures
Denture Stomatitis
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.
Asmaa N, Elboraey, Ass,Pro principal investigator
National Research Centre, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ozonated water and Chlorhexidine mouthwash in people with Denture Stomatitis, run by National Research Centre, Egypt 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 4 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 1 Sep 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 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.
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?
Candida albicans colonies (time frame: day one, 7th day, 14th day and 30th day). 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 1 Sep 2023.