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

Conditions

None listed

Brief summary

Dental plaque is a biofilm of microorganisms found on a tooth surface, embedded in a matrix of polymers of host and bacterial origin. The presence of dental plaque can provoke gingivitis and periodontitis. This work aims to evaluate the non-inferiority of two different mouthrinses, one synthetic and one natural, respect on a mouthrinse gold standard as an aid for home oral hygiene.

Vitiello F, Monterubbianesi R, Sparabombe S, Bourgeois D, Tosco V, Alshehri FA, Carrouel F, Putignano A, Orsini G.

2024-01-163 citations

10.1186/s12903-023-03779-1

Interventions

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 ora

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Healthy volunteers

No

Inclusion criteria

minimum of 20 teeth, good physical health, gingivitis, periodontitis stages I or II

Exclusion criteria

1) active caries 2) wearers of dentures and of orthodontic appliances; 3) severe malocclusion; 4) use of oral antiseptics in the previous three months; 5) subjects with medical disorders; 6) undergoing antibiotic or other antimicrobial therapy in the previous 3 months; 7) the presence of any systemic disease that could alter the production or composition of the saliva or dental plaque; 8) individuals with an allergy to any ingredients used in the study; 9) pregnant women.

Outcome results