# Comparative Effectiveness of a Commercial Mouthwash and an Herbal Infusion in Oral Health Care
## 11 A BSTS Method
### Clinical Trial of a Commercial Mouthwash and an Herbal Infusion  
The randomized multicenter comparative clinical study was conducted in accordance with the ethical standards, according to good practice and ethical principles. The study comparatively evaluated the effectiveness of a commonly used mouthwash and of an infusion of herbs that was created in the Faculty of Medicine and Pharmacy Oradea, University of Oradea. The clinical trial was conducted in the Faculty of Medicine and Pharmacy of Oradea University, the Dental Medicine Faculty of George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Targu Mures, and the Dental Medicine Faculty of Titu Maiorescu University of Bucharest. The null hypothesis of the clinical trial was started from the premise that the efficacy of the used methods in decreasing plaque index (PI) and gingival index (GI) is not different. The participants included in this study were randomly assigned to one of the two groups, CM group, which rinsed with the commercial mouthwash, and the IM group, which used the herbal infusion, using an algorithm [22] that generated a random number for every patient (odd for the CM group, even for the IM group). The participants were informed about procedures, agreed to voluntarily participate in the study, and signed their consent forms for participation in the study (Ethics Committee number 21/23.07.2018). The inclusion criteria were represented by the patients who voluntarily registered in the study program: cooperating patients with good oral hygiene who did not use mouthwashes in the last six months; systemically healthy patients without acute or chronic diseases; patients without dental, periodontal, mucosal lesions of the oral cavity; no antibiotic therapy and no other therapies or professional cleaning at least six months prior to the start of this study; minimum number of teeth 24; and age range between 20-29 years old. The exclusion criteria were represented by patients with dental, mucosal, or/and periodontal diseases/treatments within the period of research; anti-inflammatory and antibiotic therapy within the period of research; adverse effects or allergic reactions after the use of substances contained by the researched mouthwash and/or infusion; history with general chronic diseases; pregnancy; and lactation. All examinations of this clinical trial were performed by dentists who realized an inter-examiner calibration before the beginning of the study to ensure the coherence of examinations and diagnosis. They used the same bacterial plaque-disclosing agent (erythrosine tablets) and the same examination instruments. The working protocol received by all examiners from the coordinators of the Oracle center included the assessment of the Silness-Loe plaque index (PI) and the Loe-Silness gingival index (GI). The Silness-Loe plaque index (PI) was imagined by authors in 1964 [8] and estimates the presence of dental plaque deposits on the cervical area of the 4 coronal surfaces of the teeth. The arithmetic mean of the values represents the plaque index that follows the stages of plaque formation at the level of the dento-periodontal junction: 0 = absence of plaque; 1 = plaque that can be evidentiated with the probe; 2 = visible plaque; 3 = abundant plaque deposits. PI = sum of all areas/no. of examined surfaces. From the average of the 4 values (labial/buccal, mesial, oral, and distal), the specific index of each tooth resulted. The plaque indices for the six teeth (1.6, 1.2, 2.4, 3.6, 3.2, 4.4) were added and then divided by six in order to obtain the PI for each patient [8]. The Loe-Silness gingival index (GI) quantifies the state/severity of gingival inflammation, determined at the level of the same four cervical areas of a dental crown as in the PI. The GI was assessed by inserting a periodontal probe in the gingival sulcus or in the gingival recessions.