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J Contemp Dent Pract ;20 11 — Conflict of interest: There are no conflict of interest for authors of this clinical trial. The specific mode of action of Dermovitamina Aftaclin Pasquali Healthcare s. Background: Recurrent or occasional aphthous lesions represent a painful oral condition with high prevalence. Since the etiology is still unclear and most likely related to a dysfunction in the local immune system, several treatment strategies have been proposed, including systemic agents, local agents, and laser therapy, to reduce the pain and discomfort for the patient without acting on the causes. Materials and methods: The purpose of the present randomized study was to assess the clinical efficacy of a new topical gel with mucoadhesive property to reduce the pain and the dimension of the aphthosis lesions. Fifty patients presenting at least one minor ulcer were randomized to a control group placebo prescription , a first test group topical agent with laser , and a second test group topical agent only. The healing rate, the visual analog scale VAS score for pain, and the diameter reduction were monitored for 10 days. Results: Both test groups showed better results than control group, significant clinical efficacy, and a median total reduction time of 4 days with no significant adjunctive benefit from the use of laser. Conclusion: The clinical results are encouraging; nevertheless other studies are needed to valid this kind of treatment. Clinical significance: The present randomized clinical study suggested that the use of topical mucoadhesive agents could represent a valid therapy for minor aphthous lesions. Keywords: Adjuvant therapy, Laser therapy, Mucoadhesive gel, Oral aphthous ulcers, Recurrent aphthosis. The disease uses to manifest in the form of outbreaks, with a chronic and self-limiting lesion. Two clinical subtypes of aphthous lesions have been established according to size, number, and duration of the outbreaks: minor aphthous and major aphthous lesions. They are commonly located in the non-keratinized mucosa and have an average healing time between 10 days and 14 days. Pain is the most relevant symptom, but it often seems to be not even related to ulcer dimension. The onset of the lesion may be caused by a several local events, including local trauma, unfitted prothesis, stress for anesthesia injection, vitamin deficiencies B 12 , folic acid , iron deficiency, possible sensitivity to sodium lauryl-sulfate, and other iatrogenic factors. The advantages of this type of administrations are mainly related to the avoidance of stomach acidity and the prompt action to the target site. In addition to that, this type of products is well-tolerated by patients. In the last years, we are witnessing an ecological retrofit of the therapeutic approach toward several oral conditions; therefore, it is important to explore the clinical efficacy of new non-pharmaceutical agents in rigorous trial designs. The purpose of the present randomized controlled clinical study was to evaluate the clinical effectiveness of a new topical product with mucosal delivery on healing rate and reducing pain of aphthous lesions at a 10 day period when compared to no treatment and to laser therapy. This randomized clinical study followed the Declaration of Helsinki so that a written informed consent was signed by all the participants before starting the study. Sample size was computed according to the results of the study by Yilmaz et al. A total of 50 patients with recurrent aphthous stomatitis were included in the present study and completed the intended follow-up. Participants were 18 years and older with a validated history of recurrent aphthous stomatitis. The presence of at least one minor aphthous lesions in the buccal or labial non-keratinized oral mucosa with a duration of maximum 3 days was the main inclusion criterion. Exclusion criteria were as follows: traumatic ulcers, the presence of systemic diseases that predispose to oral mucosa lesions that could be misunderstood as aphthosis lesion, major herpetic lesions, and ulcers caused by systemic medications or other iatrogenic factors. The new adhesive oral gel that was put to test is called dermovitamina aftaclin Pasquali Healthcare s. This new product is an adjuvant agent that creates a protective film on the wound reducing pain and discomfort for aphthosis making a faster healing. Each subject with aphthous lesions have been randomly assigned by the toss method to three groups:. Patients were encouraged to apply the elect product as many times as required to achieve relief during the day and they were asked to report this frequency on a questionnaire. Patients scored their pain and discomfort level for each aphthous lesion by marking a point on a visual analog scale VAS score with 10 points. Visual analog scale scores have been recorded immediately and at 4 control sessions, at days 1, 3, 7, and 10 after treatment. The clinician who recorded the data at 1, 3, 7, and 10 days did not know the group of treatment as well as the patient who obviously did not know about the composition of domiciliary gel placebo or Dermovitamina Aftaclin. For these reasons, the study could be defined as double blinded: only the first clinician at T0 who performed the randomization and did the first treatment knew about the groups. The ulcer diameter was measured with a standard periodontal probe and intraoral digital photographs. Each value was recorded into an electronic database and the conversion of data into an executable file allowed statistical computing on a free software environment R Studio 3. Summary statistic was done first to obtain mean and standard deviation of each variable. At the initial visit 0 day , no differences between groups were reported regarding age, gender, ulcer size, and pain intensity. Table 1 shows the baseline data of patients enrolled in different groups. A total of 50 patients were included and 48 completed the follow-up; the anamnestic data were homogeneous in the three groups of treatment male:female in every group. The maximum reduction in diameter occurred at a 3 day evaluation. There were no significant differences in diameter reduction between the two test groups. In the intervention groups, there was a significant reduction in ulcer size on the third day of treatment in most patients, while for the placebo group, no decrease in ulcer size was observed on these days, and a size reduction was observed only after 7 days Fig. Patients were asked to answer whether the pain relief was immediate and how efficient it was. The two test groups behaved similarly: the pain was reduced immediately, and the analgesic effect sustained during the 3 days afterward. There was a significant difference with the control group in which no relief was recorded at all Fig. The efficacy onset was sensibly higher in both the test groups without adjunctive benefit from laser. Both the test groups were significantly more efficient than the placebo Fig. Figure 6 shows the frequency of distribution of patients according to the efficacy onset time recorded. Most patients from the intervention groups recorded complete ulcer healing during the first 7 days; on the contrary, no patients in the placebo group recorded healing of ulcers during the first 5 days of treatment. Level of patient satisfaction was scored on a VAS with 10 values. All patients in the intervention group recorded high scores. The clinicians reported high appreciation for the gel performance in terms of clinical efficacy and ease of use. The present analysis inquired the clinical effect of a topical agent against aphthous lesions in a randomized cohort clinical study. The new formula was compared with a placebo and with the laser therapy which is, by far, considered the most powerful method in non-respondent oral aphthous lesions. For these reasons, the laser therapy is often not used to treat minor lesions, because of the cost and the time. The results of the present study suggested that topical agents adhering to the oral mucosa might be considered as the first choice of treatment in minor ulcers. In Figures 4 to 6 is shown a minor aphthosis lesion at T0, T1, and T2 after the use of the oral gel with Dermovitamina Aftaclin. According to the clinical results of the present study and as shown in pictures, the ulcer healed in 3 days T2. The topical agent was also compared with the use of both the agent and laser therapy. In both groups, the median healing time after treatment was 4 days with no adjunctive benefit in terms of pain reduction, diameter shrinkage, or efficacy onset from the laser supplement. Despite the limitation of the present study, such as the small size sample, the present findings agreed with the results from Zand et al. On the contrary, the use of topical mucoadhesive agents is a novel, promising method against mechanical trauma and inflammation at the ulcer site. In fact, this new product is an adjuvant agent that creates a protective film on the wound reducing pain and discomfort for aphthosis making a faster healing. This kind of home-care therapy is classified as a proactive therapy because it helps the patients to defend himself and heal thanks to his own endogenous anti-inflammatory, antioxidant, and healing mechanism. Creating a mechanical film on the lesion protects the patients from pain, stabilizes the coagulum improving the healing, and prevents supra infection so that patients do not have to intake other medications antimycotics or antibiotics. Other type of local domiciliary proactive therapy could be the ozone therapy because it modulates immune response, reduces inflammation, and promotes healing of the damaged tissues. Non-pharmaceutical products are a promising source for the innovation of new therapeutic agents, also because of the fewer adversative properties or side effects than traditional medication. One other frequent oral mucosa lesion may be present in patients with prolonged antitumoral therapy. In order to treat this kind of lesions, oncologic patients are often monitored by dentists together with general doctors and oncologic to control complications and to avoid those lesions became chronic. Non-pharmaceutical products might be useful to facilitate healing process, preventing systemic complications such as dehydration, malnutrition, and interaction with other drugs and allergies. The patients in the intervention groups were greatly satisfied with the effect of the topic agent and with its effects on their quality of life, as this accelerated the onset of ulcer size reduction, prolonged the duration of pain relief, and accelerated the lesions healing time. Further studies with larger sample sizes and with the inclusion of major aphthous lesions are recommended to support these scouting findings. The present randomized clinical study suggested that the use of topical muco-adhesive agents could represent a valid therapy for minor aphthous lesions with great performance in terms of pain relief and healing rate. Treatment of recurrent aphthous stomatitis. A literature review. J Clin Exp Dent ;6 2 :e DOI: Recurrent aphthous stomatitis: a review. J Oral Pathol Med ;41 8 — Recurrent aphthous stomatitis. Dental Clin ;49 1 — Recurrent aphthous ulcers today: a review of the growing knowledge. Int J oral Maxillofac Surg ;33 3 — Barrons RW. Treatment strategies for recurrent oral aphthous ulcers. Am J Health Syst Pharm ;58 1 — Effect of laser on pain relief and wound healing of recurrent aphthous stomatitis: a systematic review. Lasers Med Sci ;32 4 — Relieving pain in minor aphthous stomatitis by a single session of non-thermal carbon dioxide laser irradiation. Lasers Med Sci ;24 4 — Treatment of recurrent aphthous stomatitis with Er,Cr:YSGG laser irradiation: a randomized controlled split mouth clinical study. J Photochem Photobiol B ;—5. Promoting wound healing in minor recurrent aphthous stomatitis by non-thermal, non-ablative CO 2 laser therapy: a pilot study. Photomed Laser Surg ;30 12 — A short-term study of the effects of ozone irrigation in an orthodontic population with fixed appliances. Eur J Paediatr Dent ;20 1 — An evaluation of the efficacy of a topical gel with triester glycerol oxide TGO in the treatment of minor recurrent aphthous stomatitis in a Turkish cohort: a randomized, double-blind, placebo-controlled clinical trial. Design, formulation and evaluation of an oral gel from punica granatum flower extract for the treatment of recurrent aphthous stomatitis. Adv Pharm Bull ;6 3 — The effect of bee propolis on recurrent aphthous stomatitis: a pilot study. Clin Oral Investig ;11 2 — Buccal films as a dressing for the treatment of aphthous lesions. J Oral Pathol Med ;46 4 — Propolis-based niosomes as oromucoadhesive films: a randomized clinical trial of a therapeutic drug delivery platform for the treatment of oral recurrent aphthous ulcers. Sci Rep ;8 1 Propolis as an adjuvant to non-surgical periodontal treatment: a clinical study with salivary anti-oxidant capacity assessment. Minerva Stomatol ;67 5 — Oral mucosal injury in oncology patients: perspectives on maturation of a field. Oral Dis ;21 2 — RESULTS At the initial visit 0 day , no differences between groups were reported regarding age, gender, ulcer size, and pain intensity.

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Account Options Anmelden. Meine Mediathek Hilfe Erweiterte Buchsuche. A Death in Tuscany. Michele Giuttari. In the picturesque Tuscan hill town of Scandicci, the body of a girl is discovered, lying by the edge of the woods. The local police investigate the case? Because toxins were discovered in the girl's body, many assumed that she died of a self-inflicted drugs overdose. But Ferrara quickly realises that the truth is darker than that: he believes that the girl was murdered. And when he delves deeper, there are many aspects to the case that convince Ferrara that the girl's death is part of a sinister conspiracy? Im Buch. Inhalt Abschnitt 1. Abschnitt 3. Autoren-Profil Michele Giuttari is former head of the Florence police force , where he was responsible for re-opening The Monster of Florence case and jailing several key Mafia figures. He is now a special adviser to the interior minister in Rome, with a special remit to monitor Mafia activity. Abschnitt 1. Abschnitt 2.

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