Journal of Oral Hygiene & Health
Open Access

Gingivitis is characterized by inflammation of the gums due to the build-up of dental plaque along the gum line. Inadequate oral hygiene practices, such as insufficient brushing and flossing, contribute to the formation of plaque and the development of gingivitis. Symptoms include redness, swelling, tenderness, and bleeding of the gums [1].

Gingivitis can affect individuals of all ages and is influenced by various factors. Hormonal changes during puberty, pregnancy, and menopause can render gums more sensitive and prone to inflammation. Systemic diseases like diabetes and immunodeficiency disorders weaken the immune system, increasing susceptibility to gum infections and gingivitis. Genetic predisposition, stress, poor nutrition and substance abuse also play a role in the occurrence and progression of gingivitis [2].

Implementing proper oral hygiene practices, including regular and thorough brushing, flossing, and using antimicrobial mouth rinses or gels as advised by dental professionals, is crucial. Professional dental cleanings, known as scaling and root planning, Jul be necessary to eliminate stubborn plaque and tartar [3].

Researchers and dental professionals have explored alternative treatment modalities to enhance gingivitis management. One promising formulation is BMG0702 gel, registered as medical device by BMG Pharma SpA: it is film-forming formulation, which combines hydrogen peroxide and hyaluronic acid. Hydrogen peroxide, renowned for its antimicrobial properties, serves as an antiseptic and oxidizing agent, reducing oral bacteria associated with gingivitis. Hyaluronic acid, a natural component of connective tissues, aids in tissue healing and regeneration.

This formulation showed its efficacy against gingivitis. Its properties enable prolonged contact with gingival tissues, facilitating better penetration and sustained release of functional ingredients, thus improving outcomes in gingivitis management.

T A randomized, controlled clinical trial was conducted to compare the outcomes of individuals diagnosed with gingivitis, some receiving the BMG0702 formulation versus control groups receiving a placebo or alternative treatment.

Materials and Method

Study design

The study employed a randomized parallel double-blinded controlled 4-arm design. The purpose of the study was to evaluate the efficacy of the tested product, BMG 0702 compared to control products (BMG0702 product A, Placebo product B, Gengigel product C and Corsodyl gel product D) on different variables related to gingival health. The study assessed outcomes such as pain, bleeding (mSBI - Modified Sulcus Bleeding Index), plaque formation (Plaque Index, Volpe–Manhold index), staining index, FMBS (Full Mouth Bleeding Score), and FMPS (Full Mouth Plaque Score) in four different groups of patients using four different products.

Samples

Patients over 18 years of age of both sexes were recruited at the Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico di Milano, Italy. Before participating, patients were provided with information about the study’s purpose, aims, and risks and they signed informed consent forms. Although the distribution of age was homogeneous across each group (ANOVA for age distribution, p-value ≥ 0.05), the distribution of sex was not homogeneous, with more females recruited in each group (Chi-square test for sex distribution, p-value ≤ 0.05).

Measured outcomes

The study measured various outcomes using methods outlined in the WHO Oral Health Surveys Basic Methods 2013. The following indices were utilized:

• VAS Score: Visual Analogy Scale used to subjectively measure acute and chronic pain on a scale of 1 to 10, with 1 representing no pain and 10 representing the worst pain [4].

• Plaque Index (IP): Used to evaluate the level of plaque formation on tooth surfaces and assess the efficacy of products in plaque removal and prevention [5].

• mSBI (Modified Sulcus Bleeding Index): Measures bleeding upon probing, categorized into four scores ranging from no bleeding to heavy or profuse bleeding [6].

• Volpe–Manhold Index (VMI): Measures supragingival calculus in increments.

• Staining Index (SI): Scores the staining of teeth. FMBS (Full Mouth Bleeding Score): Assesses bleeding score across the full mouth [7].

• FMPS (Full Mouth Plaque Score): Evaluates plaque score across the full mouth.

Statistical analysis

The statistical analysis was performed using IBM SPSS software version 22.0, with a significance level set at p-value = 0.05. Normal distribution of data was tested using the Shapiro-Wilk normality test. Since the majority of the data were not normally distributed (e.g., IP, VM, SI) with p-value ≤ 0.05, non-parametric tests were utilized for the analysis [8].

Sample size power (SP)

Statistical power was calculated using G*Power software prior to patient recruitment to determine the required sample size to achieve a minimum statistical power of 0.80. A total of 30 patients per product were recruited, except for Product D, which had 31 patients, resulting in a total of 121 patients. The sample size was determined to be sufficient to achieve a statistical power of 0.80 for the selected tests [9].

Results

The study compared the efficacy of BMG0702 vs chlorhexidinebased gel and placebo in a double-blinded randomized 4-arm study conducted over 21 days with a total of 121 patients.

Measured outcomes

At the start of the study on Day 1, there were no statistically significant differences (p-value ≥ 0.05) in VAS, mSBI, plaque index, VMI, SI, FMBS, and FMPS between the four groups. Similarly, at time points T1 and T2, there were no statistically significant differences (p-value ≥ 0.05) in any of the tested variables between the four groups [10,11].

Statistical comparisons were made using the Wilcoxon signed-rank test to assess the progress over time, comparing T0 and T1, as well as T1 and T2. In all four groups, statistically significant changes (p-value ≤ 0.05) were observed in mSBI, FMBS, FMPS, and VMI at all-time points, indicating progress in these variables over time.

Overall, the study did not show statistically significant differences in the measured variables between the four groups at the start of the study or at T1 and T2. However, there were variations in the effectiveness of the products in reducing pain and plaque index over time, with product C showing slightly less effectiveness in reducing plaque formation compared to the other products.

Discussion

The present study aimed to evaluate the efficacy of BMG0702 compared to chlorhexidine, HA and placebo in the treatment of gingivitis, as measured by various variables related to gingival health. The results showed that all four groups did not exhibit statistically significant differences in VAS, mSBI, plaque index, VMI, SI, FMBS, and FMPS at the start of the study on Day 1, indicating similar baseline conditions between the groups.

Furthermore, at time points T1 and T2, there were no statistically significant differences observed in any of the tested variables between the four groups. This suggests that the different products, including BMG0702, chlorhexidine, HA and placebo, showed similar results on the measured outcomes within the study duration.

When assessing the progress over time, the statistical analysis revealed statistically significant changes in mSBI, FMBS, FMPS, and VMI within all four groups. It means that all products, including BMG0702, showed improvement in these variables over the course of the study and that BMG0702 could be considered a valid alternative to the current therapeutic approaches like chlorhexidine.

The lack of significant differences between the groups at baseline and during the study duration raises some important considerations. The tested products, including BMG0702, chlorhexidine, and HA based products have similar effects on the measured variables in the treatment of gingivitis; this finding highlights the need for further investigation and potentially larger sample sizes to discern more subtle differences between the treatments.

The effectiveness of BMG0702 in reducing pain is an interesting finding and indicates that BMG0702 has a potential advantage in managing pain associated with gingivitis compared to the other tested products, in particular against chlorhexidine which allows a limited period of use This outcome could be linked to the specific composition and mode of action of BMG0702, that combines a film forming and an antibacterial activity.

Conclusion

The study findings indicate that all four products, including BMG0702, showed comparable effectiveness across the selected variables. However, by the end of the study at T2, there were no significant differences observed in any of the variables, suggesting similar outcomes among all compared products. Therefore, the study concludes that BMG0702 demonstrates efficacy equivalent to that of established products such as Chlorhexidine and HA-based formulations.

No adverse events were reported, and patients did not report any issues or disorders following the use of the tested products. To further validate these findings, it is recommended to conduct future studies with more homogeneous groups in terms of sex. This would help confirm the results and provide a more comprehensive understanding of the effects of the tested products.

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