Methods
bleeding, gingivitis, diabetes
PLAQUE, BLEEDING, GINGIVITIS, DIABETES
This multicenter, parallel-group, double-blind, placebo-controlled randomized clinical trial recruited patients from two primary healthcare centers (Loja and Huetor Tajar) in the province of Granada (Southern Spain) and from the Clinic of the School of Dentistry of Granada University from July 2021 until September 2022. The study complied with the principles of the 2013 revision of the Declaration of Helsinki and was approved by the Biomedical Research Ethics Committee of Andalusia (ref.2184-N-20.). Written informed consent was obtained from all participant at the time of being enrolled in the study. The trial is registered on the ClinicalTrials.gov webpage (Study on the effects of a toothpaste in the microbiome and clinical parameters in patients with oral dysbiosis. ref. NCT05463484, 19/07/2022) and reported in accordance with CONSORT guidelinesInclusion criteria were age between 18 and 70 years, the presence of at least 20 teeth without counting third molars, a diagnosis of gingivitis (index of bleeding on probing ≥ 10%) according to the 2017 World WorkshopPatients were randomly assigned by Mucosal Innovations S.L to one of the following three toothpaste groups using a random number generator (The researcher gave the corresponding toothpaste to each patient, with both being blinded to the type of toothpaste, which was labeled with a code. Patients were instructed to brush their teeth with the assigned toothpaste for 4 min three times a day for 4 months and to use no other oral hygiene product. Clinical evaluations were performed at baseline (T0), 2 months (T2), and 4 months (T4) with the exception of the pH measurement (at T0 and T4). Patients were asked not to eat or smoke and to drink only water during the four hours before appointmentsData were gathered on patient age, sex, schooling level (compulsory schooling, high school, vocational training, and university education), tobacco consumption (cigarettes/day), alcohol consumption (standard drink units [SDUs]/day), and diabetes (yes/no). Scores were also collected for the plaque index proposed by TonettiSalivary pH was determined in saliva gathered at rest at T0 and T4 using PH 60 DHS equipment (XS Instruments, Carpi [MO], Italy) and an electrode (ref. H-238150) with diameter of 6 mm and minimum immersion of 15 mm that scales the pH from 0 to 14.