Anti-inflammatory and Anti-plaque Efficacies of Mouth Rinse Containing Hyaluronic Acid and Hydrog… (NCT05787600) | Clinical Trial Compass
CompletedPhase 3
Anti-inflammatory and Anti-plaque Efficacies of Mouth Rinse Containing Hyaluronic Acid and Hydrogen Peroxide
Iraq54 participantsStarted 2023-03-03
Plain-language summary
The goal of this clinical trial is to test efficiency of using mouth rinse containing (H2O2 and HA) over a period of two weeks to control on gingival inflammation and plaque accumulation through measuring the clinical periodontal parameters (Gingival Index (GI), Bleeding on probing (BOP) and modified Quigley-Hein Plaque Index (mQHPI ) in comparison with Chlorhexidine (CHX) and placebo mouth rinses in patients with biofilm induced gingivitis.
Objectives:
* Evaluate the clinical efficiency of using mouth rinse containing (H2O2 and HA) over a period of 14 days to control on gingival inflammation and plaque accumulation through measuring the clinical periodontal parameters (Gingival Index, Bleeding on probing and modified Quigley-Hein Plaque Index in comparison with Chlorhexidine and placebo mouth rinses in patients with biofilm induced gingivitis.
* Measuring levels of salivary cytokines, Interleukin 1 beta (IL-1B) and Interleukin 6 (IL-6) at baseline visit before using mouth rinse and after 14 days of using the mouth rinse containing H2O2 and HA compared to chlorhexidine and placebo mouth rinses.
* Evaluate subjects' perception of a mouth rinse (H2O2 and HA), CHX and placebo mouth rinses after 14 days from using three mouth rinse
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subjects aged ≥ 18 years-old.
* participants who were apparently systemically healthy.
* Presence of ≥ 20 teeth.
* Patients with generalized gingivitis (having \>30% bleeding sites with no PPD \>3 mm, intact periodontium and no loss of periodontal attachment .
* Patients without presence of supra- or subgingival calculus
Exclusion Criteria:
* Patients who refuse to write an informed consent form.
* Extensive untreated dental caries and diseases of hard and soft palate.
* Those having periodontitis.
* Ongoing orthodontic treatment.
* History of antibiotics intake within the past 3 months.
* Pregnant or intended to and lactating mother.
* Smoker or alcoholism
* Using mouthwash within past one month.
* Those with a recent tooth extraction.
* Those having a history of hypersensitivity to any product used in the present study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.