Clinical and side effects evaluation of a Chlorhexidine Mouthwash associated with an antimicrobial substance found in citrus fruit and Hyaluronic Acid

Clinical and side effect evaluation of Chlorhexidine mouthwash in combination with Citrox and Hyaluronic Acid

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

REBEC

Registry ID

RBR-7sfkbgw

Enrollment

Unknown

Registered

2025-10-13

Start date

2019-04-26

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral and Dental Hygiene Products

Interventions

Seventy-five participants were randomly allocated into three groups: Group 1, 0.12% Chlorhexidine CHX + 1% Citrox (PerioPlus Protect) 10 ml every 12 hours for 5 days

Group 2, 0.09% Chlorhexidine CHX + 1% Citrox + 0.2% Hyaluronic acid HA (PerioPlus Regenerate) 10 ml every 12 hours for 5 days

Control, 0.12% Chlorhexidine CHX (Periogard)10 ml every 12 hours for 5 days Gingival Bleeding Index (GBI), Visible Plaque Index (VPI), and Tooth Staining (TS) were objectively measured by the examiner

1 = presence) Subjective data on side effects (pain, burning, xerostomia, altered taste, pigmentation, bitterness) were collected via a questionnaire Following T1, participants received oral hygiene i

E05.318.308.980.438.300.675

Eligibility

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: subjects of both genders;aged 18 to be 60 years;good general health without systemic diseases;a minimum of 20 teeth;no periodontal sites with a probing depth greater than 3 mm;and no dental caries or restorations with infiltrations

Exclusion criteria

Exclusion criteria: sistemic diseases;periodontal diseases and dental cavities

Design outcomes

Primary

Measure	Time frame
Evaluate clinically the efficacy of 3 Chlorhexidine mouthwashes with different formula and concentrations, 0,12% Chlorhexidine control group, 0,12% Chlorhexidine with Citrox Group 1 and 0,09% Chlorhexidine with Citrox and Hyaluronic Acid group 2 through the Gingival Bleeding Index (GBI)parameter It was expected to find a significant reduction in the GBI in the 2 groups where the citrox was associated A significant reduction was observed in the all 3 groups from baseline to T1 (P=0.003; p=0.004; p=0,04) There were no significant differences between the groups at baseline and T1 (p=0.5, p=0.6)	—

Measure

Time frame

Evaluate clinically the efficacy of 3 Chlorhexidine mouthwashes with different formula and concentrations, 0,12% Chlorhexidine control group, 0,12% Chlorhexidine with Citrox Group 1 and 0,09% Chlorhexidine with Citrox and Hyaluronic Acid group 2 through the Gingival Bleeding Index (GBI)parameter It was expected to find a significant reduction in the GBI in the 2 groups where the citrox was associated A significant reduction was observed in the all 3 groups from baseline to T1 (P=0.003; p=0.004; p=0,04) There were no significant differences between the groups at baseline and T1 (p=0.5, p=0.6)

—

Secondary

Measure	Time frame
Evaluate, through a questionnaire, Side Effects perceived by the patients after using 3 Chlorhexidine mouthwashes with different formula and concentration, 0,12% Chlorhexidine control group, 0,12% Chlorhexidine with Citrox group 1 and 0,09% Chlorhexidine with Citrox and Hyaluronic Acid group 2 It was expected to find a fewer side effects perceived by the patients in the 2 group where the Citrox was associated A statistically significant difference in side effect responses was observed between the groups (p = 0.00018) Based on this difference, the post hoc Mann-Whitney test was performed, revealing a significant difference between the Group 2 and Control group (p= 0,000022), as well as between group 1 and group 2 (p= 0,00032) No significant difference was found between the control group and group 1 (p=0,42) A total of 19 side effects were reported in the control group, 11 in group 1, and 7 in group 2	—

Measure

Time frame

Evaluate, through a questionnaire, Side Effects perceived by the patients after using 3 Chlorhexidine mouthwashes with different formula and concentration, 0,12% Chlorhexidine control group, 0,12% Chlorhexidine with Citrox group 1 and 0,09% Chlorhexidine with Citrox and Hyaluronic Acid group 2 It was expected to find a fewer side effects perceived by the patients in the 2 group where the Citrox was associated A statistically significant difference in side effect responses was observed between the groups (p = 0.00018) Based on this difference, the post hoc Mann-Whitney test was performed, revealing a significant difference between the Group 2 and Control group (p= 0,000022), as well as between group 1 and group 2 (p= 0,00032) No significant difference was found between the control group and group 1 (p=0,42) A total of 19 side effects were reported in the control group, 11 in group 1, and 7 in group 2

—

Countries

Brazil

Contacts

Public ContactRafael Dias

Universidade de Mogi das Cruzes

rafaeldias@umc.br+55 (11)47987139

Outcome results

None listed

Source: REBEC (via WHO ICTRP)