A Phase 3 interventional study of Filming mouthwash formulation, enriched with Hydrogen Peroxide and Hyaluronic Acid and Chlorhexidine mouthwash in Gingivitis and Bleeding Gum, sponsored by University of Milan. Status unknown at 1 site in Italy. Open to participants aged 12 Years to 50 Years. Per ClinicalTrials.gov, last updated 2020-06-18.
Sponsored by University of Milan · Phase 3, Interventional, and Treatment
A clinical study to evaluate the efficacy and safety of a mouthwash containing Hydrogen Peroxide, Sodium Hyaluronate and Glycine in the prevention and management of complications associated gingivitis by film forming action.
50 subjects will be enrolled, who show with gingivitis caused by accumulation of plaque and/or tartar selected consecutively. Subsequently, subjects will be equally divided and randomized into the test group or control group.
During the three examinations, the subjects will undergo the collection of bleeding and plaque indices according to Silness J \& Loe H 3,4. Four surfaces per tooth (vestibular, lingual/palatal, mesial, distal) will be considered.
609 studies on the registry are indexed under Gingivitis; 107 are open to participants now.
This study's planned enrollment of 50 is below the median of 63 across 494 interventional studies indexed under Gingivitis.
Browse Gingivitis studies →University of Milan is the lead sponsor of 182 studies on the registry; 28 are open to participants now.
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Subjects will then be given the test product, BMG0703, to be used twice a day after meals and after normal oral hygiene procedures. Next, the subjects will be re-evaluated after 3 days and after one month.
Drug: Filming mouthwash formulation, enriched with Hydrogen Peroxide and Hyaluronic Acid
Subjects will then be given a 0.2% Chlorhexidine product, to be used twice a day after meals and after normal oral hygiene procedures. Next, the subjects will be reevaluated after 3 days and after one month.
Drug: Chlorhexidine mouthwash
Subjects will then be given a placebo product, to be used twice a day after meals and after normal oral hygiene procedures. Next, the subjects will be reevaluated after 3 days and after one month.
Drug: Placebo
Subjects will then be given the test product, BMG0703, to be used twice a day after meals and after normal oral hygiene procedures. Next, the subjects will be re-evaluated after 3 days and after one month.
Also known as: BMG0703
Subjects will then be given Chlorhexidine 0.2%mouthwash, as an active comparator, to be used twice a day after meals and after normal oral hygiene procedures. Next, the subjects will be re-evaluated after 3 days and after one month.
Also known as: Chlorhexidine 0.2%
Subjects will then be given a placebo product to be used twice a day after meals and after normal oral hygiene procedures. Next, the subjects will be re-evaluated after 3 days and after one month.
Also known as: Placebo product
Change in Bleeding index
Subjects will undergo the measurement of bleeding index according to Silness J \& Loe. Four surfaces per tooth (vestibular, lingual/palatal, mesial, distal) will be considered. Data will be collected based on four possible clinical conditions: Code 0: absence of bleeding during probing depth measurement; Code 1: absence of bleeding during probing depth measurement, presence of redness and oedema; Code 2: presence of bleeding during probing depth measurement with redness and oedema; Code 3: spontaneous bleeding Higher score means worse outcome.
Time frame: 0, 3, 30 days
Change in Plaque index
Subjects will undergo the measurement of plaque index according to Silness J \& Loe. Four surfaces per tooth (vestibular, lingual/palatal, mesial, distal) will be considered. Data will be collected based on four possible clinical conditions: Code 0: absence of plaque; Code 1: presence of plaque not visible to the naked eye but evidenced by the periodontal probe passage; Code 2: presence of plaque at the level of the gingival margin; Code 3: abundant presence of plaque at the level of the gingival margin and/or the rest of the dental surface. The sum of the values of the four surfaces examined, divided by the very number of surfaces, will give the plaque and bleeding index value for each individual tooth. The sum of the indices of each examined tooth divided by the total number of teeth examined will indicate the overall plaque and bleeding index of the subject at that time.
Time frame: 0, 3, 30 days
Plan to share: No — Protocol data available in PDF format upon request
Start is estimated for Jun 2020; primary completion for Jul 2020, 1 month later.
Of 33 phase 3 interventional studies under Gingivitis, half reached primary completion within 3 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 6. This study's planned 1 month is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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