A randomized, double-blind, non-inferiority trial evaluating the efficacy and safety of two different mouthrinses on patients with gingival inflammation.

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2022
INTERVENTION: The following mouthrinses will be evaluated: ‐Group A: containing Propolis resin extract (1:3), Plantago lanceolata leaves extract (1:10), Salvia officinalis leaves extract (1:1) and 1.75% of essential oils from Salvia officinalis, Syzygium aromaticum buds, Mentha piperita leaves, Commiphora myrrha oleoresin and Pistacia lentiscus oleoresin (Fitomedical snc, Binasco, Milan, Italy). ‐ Group B: containing 0,09% of chlorhexidine (CHX) and CITROX® (formulation deriving from the extract of bitter orange peel) (Curaprox Italia S.r.l. , Bolzano, Italy). The patients will use the assigned mouthrinses twice a day for two weeks. At baseline a single examiner , with more than 8 years of practice, will collect the clinical parameters. All patients will receive a written instruction of the tested mouthrinses and their right dosage. The participants will be instructed to gargle 10 ml of the mouthrinse for a period of 60 seconds, after which the mouthrinse is spit out. Moreover, they will be instructed to not rinse/eat anything for 30 minutes after mouthrinse use. The patients will continue to perform their routine oral home care, adding only the assigned mouthrinse. Patient self‐report diary will be use to monitor adherence of the patient to intervention. CONDITION: Alternative and Complementary Medicine ‐ Herbal remedies Oral and Gastrointestinal ‐ Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon periodontal disease;periodontal inflammation;Gingivitis;SARS‐CoV‐2 infection; ; periodontal disease ; periodontal inflammation ; Gingivitis ; SARS‐CoV‐2 infection PRIMARY OUTCOME: The bleeding index on 6 surfaces using full mouth bleeding score.; [Baseline; 2 weeks post intervention commencement] SECONDARY OUTCOME: Detection and concentration of SARS COV‐2 [Baseline; 2 weeks post intervention commencement] The extrinsic stain using modified Lobene stain index.[Baseline; 2 weeks post intervention commencement] The patient taste appreciation using 10‐cm Visual Analogue Score (VAS). ; [Baseline; 2 weeks post intervention commencement] The plaque index on 6 surfaces using full mouth plaque score (FMPS). ; ; [Baseline; 2 weeks post intervention commencement] INCLUSION CRITERIA: minimum of 20 teeth, good physical health, gingivitis, periodontitis stages I or II
Epistemonikos ID: 7c5646a1d5b622dc4b84567e6e96c01ed7aa6c69
First added on: Aug 25, 2024