Anti-inflammatory and Anti-plaque Efficacies of Mouth Rinse Containing Hyaluronic Acid and Hydrogen Peroxide

NCT05787600 | Completed Phase 3

• 1 other identifier: 748622
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Plaque Induced Gingivitis; Mouth Diseases; Bleeding Gum; Periodontal Diseases

Keywords

Gingivitis; Plaque; Hyaluronic acid; hydrogen peroxide

Outcome Measures

Primary Outcomes (1)

• Change in Gingival index

  Subjects will undergo the measurement of gingival index according to Loe \& Silness, designed to assess the severity and quality of gingival inflammation in an individual or population. The gingival inflammation is assessed on the basis of color, consistency and bleeding on probing. The gingiva surrounding the tooth is assessed at four sites: mesio-facial papilla, facial marginal gingiva, disto-facial papilla and lingual marginal gingiva. Data will be collected based on four possible clinical conditions: 0=Normal gingiva1=Mild Inflammation-Slight change in color, Slight odema. No bleeding on probing2=Moderate inflammation-redness,odema and glazing. Bleeding on probing 3=Sever inflammation-marked redness and edema.Ulceration.Tendency to spontaneous bleeding.

  0, 14 days

Secondary Outcomes (4)

• Mean amount plaque between different comparators.

  14 days

• Assessment of the interventions by the participants through answering specially designed

  14 days

• Mean relative changes in Interleukin 1 beta and Interleukin 6 levels in salivary Fluid.

  14 days

• Changes in BOP score

  14 days

Study Arms (3)

Perhyal rinse

EXPERIMENTAL

Participants will be given the test interventions,Perhyal rinse, and will be asked to rinse with 10 ml of undiluted mouthwash for 60 s twice per day (30 min after tooth brushing) and will be instructed to refrain from eating and drinking for 30 min after rinsing.

Drug: Perhyal rinse

Chlorhexidine 0.12%

ACTIVE COMPARATOR

Participants will be given the positive-control, Chlorhexidine 0.12%, and will be asked to rinse with 10 ml of undiluted mouthwash for 60 s twice per day (30 min after tooth brushing) and will be instructed to refrain from eating and drinking for 30 min after rinsing.

Drug: Chlorhexidine mouthwash

Placebo Product

PLACEBO COMPARATOR

Participants will be given the nonactive control, distilled water, and will be asked to rinse with 10 ml of undiluted mouthwash for 60 s twice per day (30 min after tooth brushing) and will be instructed to refrain from eating and drinking for 30 min after rinsing.

Drug: Placebo

Interventions

Perhyal rinse DRUG

Filming mouthwash formulation, enriched with Hydrogen Peroxide and Hyaluronic Acid Subjects will then be given the test intervention, Perhyal rinse, and will be asked to rinse with 10 ml of undiluted mouthwash for 60 s twice per day (30 min after tooth brushing) and will be instructed to refrain from eating and drinking for 30 min after rinsing. participants will be received a toothbrush with medium-hardness bristles and a toothpaste (COLGATE). No modifications to the participants' tooth brushing technique will be permitted. Next, the participants will be re-evaluated after 14 days.

Also known as: BMG0703

Perhyal rinse

Chlorhexidine mouthwash DRUG

Subjects will then be given Chlorhexidine 0.12%mouthwash, as an active comparator, and will be asked to rinse with 10 ml of undiluted mouthwash for 60 s twice per day (30 min after tooth brushing) and will be instructed to refrain from eating and drinking for 30 min after rinsing. participants will be received a toothbrush with medium-hardness bristles and a toothpaste (COLGATE). No modifications to the participants' tooth brushing technique will be permitted. Next, the participants will be re-evaluated after 14 days.

Also known as: Chlorhexidine 0.12%

Chlorhexidine 0.12%

Placebo DRUG

Subjects will be given the nonactive control, distilled water, and will be asked to rinse with 10 ml of undiluted mouthwash for 60 s twice per day (30 min after tooth brushing) and will be instructed to refrain from eating and drinking for 30 min after rinsing. participants will be received a toothbrush with medium-hardness bristles and a toothpaste (COLGATE). No modifications to the participants' tooth brushing technique will be permitted. Next, the participants will be re-evaluated after 14 days.

Also known as: Placebo product

Placebo Product

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

University of Baghdad\ College of Dentistry

Baghdad, Bab Al-Moadham, 10047, Iraq

Location

MeSH Terms

Conditions

Mouth Diseases; Gingival Hemorrhage; Periodontal Diseases; Gingivitis; Plaque, Amyloid

Condition Hierarchy (Ancestors)

Stomatognathic Diseases; Oral Hemorrhage; Gingival Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections; Pathological Conditions, Anatomical

Study Officials

• Ahmed alyasari, B.D.S

  University of Baghdad

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The products will be packaged in such a way that they are not recognizable neither by the operator, nor by the patient. Each package will be assigned a number that in turn will refer to the type of the product. The association between the number and type of the product will be collected by another operator according to the association carried out by a dedicated software. The operator who will deliver the product will be informed about the type only at the end of the treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 54 subjects with plaque induced gingivitis, caused by accumulation of plaque, will be selected and enrolled in this study. Subsequently, subjects will be equally divided and randomly allocated for three groups, each group received a similar number of subjects (n=18) with a 1:1:1 allocation.

Study Record Dates

• First Submitted: March 3, 2023
• First Posted: March 28, 2023
• Study Start: March 3, 2023
• Primary Completion: April 20, 2023
• Study Completion: May 1, 2023
• Last Updated: October 4, 2023

Record last verified: 2023-10

Locations

IR (1)