Study Directors: Dr. med. Werner Voss, Dr. Frauke Behrens, Dr. Sigird Brune, Dr. Vanessa Gomes

1. Aim of the Study

The aim of the study was to measure and evaluate the efficacy of a photodynamic solution in the oral cavity based on a newly developed system. The product system "manadental" to be tested was conceived, developed, and brought to market readiness by Mana Health Technologies GmbH. The study (No: 2310251797) was conducted by the German testing institute Dermatest GmbH.

The product to be tested, "manadental," is not subject to the German Medicinal Products Act or the Medical Devices Act. The multi-component system (measuring glass, electronic charging station, electronic emitter) is a consumer product within the meaning of the Product Safety Act. The photodynamic liquid required as a photosensitizer is classified as a cosmetic product.

In a group of subjects, clinically objective parameters of efficacy on the gingiva, such as Bleeding-on-Probing (BoP), Plaque Index (PI), and changes in tooth color, were investigated. Part of the study also included the assessment of potential intolerances or irritations during the 4-week application.

2. Subjects, Material, and Methods

50 subjects participated in the study. The product system to be tested and the photodynamic liquid were provided free of charge by Mana Health Technologies GmbH. Participation for each subject was limited to 4 weeks.

The subject group consisted of healthy individuals in good general condition between 18 and 75 years of age. Participation in the study was voluntary and could be terminated at any time without giving reasons. All subjects maintained their existing oral hygiene routine unchanged. Subjects in the application group additionally used the "manadental" product system every other day (A2G).

It was a 2-arm, randomized study.

• 25 subjects were assigned to the control group. (CG)

• 25 subjects were assigned to the application group every other day. (A2G)

The manadental product system, including packaging, was handed over to the subjects in the application groups. A detailed instruction manual was enclosed with the product packaging. In addition, subjects received thorough training on product application at the practice.

 

2.1 Measurement Parameters

The measurement parameters were collected for each subject on the first day (T=0) and after 4 weeks (T=28). The level of significance for the parameters Bleeding-on-Probing (BoP) and Plaque Index (PI) was p < 0.05.

 

2.1.1 Bleeding-on-Probing (BoP)

To assess gum condition, Bleeding-on-Probing (BoP) according to Ainamo & Bay (1975) was used. A blunt-tipped probe is pressed against defined measurement points at the gingival margin. It is dichotomously recorded (yes/no) whether the probe manipulation causes bleeding. Six sites, distributed over the entire sulcular circumference of the tooth (in a fully developed dentition, this corresponds to 32 x 6 = 192 measurement points), are recorded dichotomously (yes/no). The unadapted BoP according to Ainamo & Bay (1975) represents the total number of bleeding probing points as a percentage of the total number of probing points. [4], [5]

In the present study, a common modification of BoP according to Ainamo & Bay was used to increase the robustness of the test. The result given in this modification expresses the total number of bleeding tooth circumferences in relation to the total number of probed teeth, and not, as in the conventional calculation, the number of bleeding tooth circumferences in relation to the total number of all probed sites. Accordingly, in this modification, a tooth whose circumoral bleeding, for example, has been reduced from 5 sites to one site, is still recorded as "bleeding". This further increases the robustness of the parameter. To further reduce the risk of bias by the examining dentist, a periodontic probe (WHO probe) calibrated to 0.2N was used in accordance with "good scientific practice."

 

2.1.2 Plaque Index (PI)

Plaque is dental biofilm consisting of several complex layers containing proteins, carbohydrates, phosphates, and microorganisms. It particularly forms where tooth surfaces are not kept clean by natural or artificial cleaning and can lead to tooth decay, periodontitis, and gingivitis. The Plaque Index (PI) was used as a quantitative assessment method to evaluate the occurrence and extent of plaque on the teeth. [4]

 

In the present study, plaque was stained with Revelator Mira-2-Ton® (Hager & Werken GmbH & Co.KG; disclosing tablets). After thorough rinsing with water, a qualified study nurse determined the extent of plaque according to the scale shown above (Figure 1) for each tooth buccally (= on the cheek-side tooth surface). The mean value of all plaque intensities determined in this way per subject represents the Plaque Index. It was calculated from the sum of all plaque intensity values divided by the number of all existing and accordingly evaluated teeth.

 

2.1.3 Tooth Shade Matching

The "Classical" shade guide from the manufacturer VITA® was used to determine tooth shade. The shades range from A1-D4®. The three-dimensional tooth replicas with corresponding shades from A1-D4 are held directly against the tooth and matched during the assessment. [6]

 

2.1.4 Clinical-Dental Medical Findings

In addition to quantitative and qualitative determinations, clinical-dental medical assessment criteria were also applied by medical staff. All subjects were examined for pathological tooth, gum, and mucous membrane changes before, during, and after the application study.

 

2.2 Study Endpoints

The endpoints of the study were the assessment of the product's efficacy on gum health measured by Bleeding-on-Probing (BoP), the product's influence on the Plaque Index (PI), and on tooth color measured using tooth shade guides. Additionally, clinical-dental medical findings were documented.

 

4. Results

4. 1 Results of Bleeding-on-Probing (BoP)

In the control group (CG), a reduction in bleeding tendency (BoP) of an average of 19.50% was recorded over the observation period. In the application group (A2G), which used the product every 2 days, a reduction in the BoP parameter of an average of 49.39% was documented over the same period.

 

The reduction in bleeding tendency in the application group (A2G), which used the product every 2 days, was highly significant compared to the control group (CG) (two-sample t-test, p = 0.0053).

 

4. 2 Results of the Plaque Index (PI)

In the control group (CG), an average reduction in the Plaque Index (PI) of 52.07% was recorded during the observation period. In the application group (A2G), which used the product every 2 days, an average reduction in the PI parameter of 63.79% was observed during the observation period.

 

The reduction in the Plaque Index in the application group (A2G), which used the product every 2 days, was not significant compared to the control group (CG) (two-sample t-test, p = 0.454).

 

4.3 Results of Tooth Shade Matching

No change in tooth color was observed in any of the 3 subject groups.

 

4.4 Results of Clinical-Dental Medical Findings

All subjects showed healthy gums and oral mucosa before, during, and after the application study. Pathological changes in gums or oral mucosa were not observed in any form. Discontinuations of the test or dental medical treatments were not carried out in any case, nor were the latter necessary. The mentioned preparation was very well tolerated and did not cause any dental medically relevant changes in gums or oral mucosa in any test person.

 

5. Interpretation and Summary

The present study with 50 subjects demonstrates that bleeding tendency (or gum bleeding) in the application group decreased by 49.39% (A2G) over the 4-week observation period. This reduction in bleeding tendency (Bleeding-on-Probing, BoP) compared to the control group (CG) is highly significant (A2G: p = 0.0053). Thus, the current analysis confirms the results of the previous in-vivo pilot study, which also showed a significant reduction in bleeding tendency in the gums after applying the photodynamic care system.

In the examination of plaque accumulation (Plaque Index) on the teeth, a strong reduction was observed in both groups within the observation period (CG = 52.07%, A2G = 63.79%). The reduction in the application group is not significant compared to the control group (A2G: p = 0.454).

The results of the Plaque Index (PI) suggest that an improved brushing performance by all subjects during the observation period led to a reduction in current plaque accumulation. In the context of the highly significant reduction in bleeding tendency among product users, it can therefore be stated that the improved brushing performance observed in the Plaque Index is not causally responsible for the high efficacy on gum health. This observation underscores the effectiveness of the new product system.

The tooth color of the subjects did not change over the entire test period.

Thus, a significant effect of the photodynamic care system "manadental" on gum health, measured by bleeding tendency, can be assumed. Based on the clinical-dental medical observation of the subjects, it can also be stated that the product is very well tolerated and does not cause any pathological changes in the teeth, gums, or oral mucosa.