Introduction
This research aimed to investigate the effect of Nano-Bio Fusion Gingival Gel ([NBFG] NanoCureTech, Gangdong-gu, Seoul, Korea) as an aid along with oral hygiene advice and routine scaling in patients with malocclusion to control treatment-induced gingivitis and periodontitis in patients undergoing fixed orthodontic treatment.
Methods
A split-mouth design, prospective analysis after application of NBFG in 32 subjects with fixed orthodontic treatment-induced gingivitis was conducted. Patients applied NBFG to their gingiva twice daily, after brushing, for 90 consecutive days. Outcomes measured included: the plaque index (PI), papillary bleeding gingival index (PBI), probing depth (PD), and clinical attachment loss using standard assessment. PI, PBI, PD, and clinical attachment loss were measured at baseline, on the seventh day of gel application, at the next visit at the orthodontic clinic (28th day), and after 90 days.
Results
From baseline to the seventh day to the 90th day, the treatment group showed significant improvement in PI, PBI, and PD over time compared with the placebo group.
Conclusions
NBFG showed positive clinical effects in patients undergoing fixed orthodontic treatment. Clinical outcomes were measured in a comparatively short period.
Highlights
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The effect of Nano-Bio Fusion Gingival Gel (NBFG) in orthodontic patients was studied.
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Gingival health improved in the NBFG group over the short study period.
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NBFG produced beneficial effects in patients with treatment-induced gingivitis.
The primary goal of fixed orthodontic treatment is to attain the ideal occlusion with function and stability using tooth movement to the optimum position by alteration of the periodontium. , Fixed orthodontic treatment has advantageous effects and also has some unfavorable effects. The literature verifies several diverse conditions accompanying fixed orthodontic treatment. These diverse conditions should not be ignored though generally, most of them, a definite cause-effect relationship has not been revealed.
In patients with fixed orthodontic treatment, the inflammatory reaction of gingival tissue can commonly be observed. Bacterial plaque is the single essential causative factor of periodontal disease, which is in agreement among researchers. Because of varieties of orthodontic attachments such as brackets, archwire, and bands in patients with fixed orthodontic treatment, plaque accumulation is inevitable on their teeth. Biological equilibrium of the mouth cavity can be altered because of the components of fixed orthodontic treatment. During fixed orthodontic treatment, the closeness of orthodontic appliances to the gingival sulcus, plaque accumulation, and the impediments they pose to oral hygiene habits further complicate the process of efficient salutary orthodontic care and discomfort. ,
Nanotechnology has taken humankind to an entirely new period of improvement in which we have new beneficial options. They comprise elements that cause numerous cellular and biochemical interactions to stimulate healing. These elements resorbed quickly and transferred to the inflamed tissues. Significance belongs to the antioxidants in the recovery process. These newer products are based on nanotechnology. In the healing of oral mucosal lesions, antioxidants can be used as exceptional adjuvants. One such product is Nano-Bio Fusion Gingival Gel (NBFG; NanoCureTech, Gangdong-gu, Seoul, Korea), containing propolis extract in the form of nanoemulsion, vitamin C, vitamin E, sodium monofluorophosphate, aloe, and green tea extract. NBFG forms a bioactive protective layer on the gingival tissues, which results in better absorption; thereby, on application, it results in improved clinical effectiveness and visible results. Nano-Bio Fusion technology of NBFG with bioactive protective layer permits the antioxidants to penetrate the moist intraoral environment, resulting in rejuvenating and revitalizing of the cells. This study is the first empirical investigation in patients that aimed to determine the effect of NBFG on plaque index (PI), papillary bleeding gingival index (PBI), probing depth (PD), and clinical attachment loss (CAL) scores.
Material and methods
The sample for this study comprised 64 patients with fixed orthodontic treatment-induced gingivitis, divided into a treatment group (NBFG) and a control group. Inclusion criteria of participants included Saudi ethnic background, aged between 15 and 25 years, diagnosed as having treatment-induced gingivitis after 6 weeks of orthodontic therapy for Angle Class I, II, or III malocclusions. Exclusion criteria included craniofacial anomalies or malformation, patient on long-term medication, temporomandibular joint dysfunction, parafunctional habits, multiple missing teeth, and periodontally compromised. NBFG or a placebo gel was applied once by a dental assistant, and training was provided to the patients so they could apply the gel themselves, regularly and on the same side, twice each day after brushing. Other details of the methodology are described in Table I .
| Characteristics | Description | |
|---|---|---|
| Study population | Patients with fixed orthodontic treatment-induced gingivitis, Saudi ethnic background, aged 15-25 y | |
| Study design | Prospective clinical intervention | |
| Intervention | Application of NBFG on the experimental side, twice a day after brushing for 90 d | |
| Comparison | Application of placebo gel on control side that contains water, thickener, preservative, sorbitol, and a small amount of peppermint | |
| Outcome | PI, PBI, PD, and CAL | |
| Sample size calculation | With 80% power, α = 0.05, and effect size ( d ) = 0.22 effect size (G∗Power software [version 3.0.10; Franz Faul Universitat, Kiel, Germany]). Hence, the appropriate total sample size for this research was 32 | |
| Randomization of patients into treatment and control group | To avoid any selection bias, a computer software program (random number generator) randomly selects numbers that will be assigned uniquely to each subject’s active and placebo control side for the NBFG and Placebo application | |
| Study groups | NBFG (experimental group) | Placebo (control group) |
| Treatment modalities | Self-ligating orthodontic bracket | Self-ligating orthodontic bracket |
| Number of subjects | 32 | 32 |
| NBFG application | First, NBFG was applied by the dental assistant, and training was provided to the patients to be applied regularly on the same side, as demonstrated. | |
| Gingival and periodontal assessment |
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| Time interval for parameters assessment | Immediately after the recruitment of samples, a trained dental assistant recorded initial baseline data for case and control groups. PI, PBI, PD, and CAL were recorded after 7, 28, and 90 d from the date of initial recruitment and assessment of baseline data | |
| Statistical analysis | SPSS Statistics (version 22.0; IBM, Armonk, NY) was used to analyze the data. Descriptive analysis was performed to obtain the mean rank values of pain among 2 groups. Series of Mann-Whitney U test was used to compare the level of PI, PBI, PD and CAL levels between 2 groups and differences between time points, that is, T1, T2, T3, and T4. Pearson correlation was used to evaluate the correlation between PI, PBI, PD, CAL, and the application of active and placebo gel | |
| Ethical statement | Written informed consent from each patient was taken; for adolescent subjects, a parent or legal guardian gave the consent. Ethical clearance was obtained from the Local Committee for Bioethics, Jouf University (reference no. 15-18-9/40) | |
The study used a split-mouth design and was triple blinded. Initially, investigators performed the coding for active and placebo gel.
For operator blinding, operators were not involved in gel application, data collection, and analysis. For patient blinding, patients were not aware of the contents of the active and placebo groups and the division of the split-mouth design. A dental assistant was involved in gel application without the knowledge of the contents. A different assistant was involved in data collection. A specialist statistician decoded the data and performed all of the relevant analyses, and the results were handed over to the investigators. Baseline (T1) data were collected immediately after the recruitment of samples for treatment and control groups. PI, PBI, PD, and CAL were recorded after 7 days (T2), 28 days (T3), and 90 days (T4).
Written informed consent was obtained from each patient; for adolescent subjects, a parent or legal guardian gave the consent. Ethical clearance was obtained from the Local Committee for Bioethics, Jouf University, Sakākā, Saudi Arabia (reference no. 5-18-9/40).
Results
Mean values of PI, PBI, PD, and CAL are presented in Table II . Mann-Whitney tests demonstrated that PI, PBI, PD, and CAL scores were not significantly different at T1 between the placebo and NBFG groups. PI scores were significantly different at T2 for the NBFG group (mean difference [Mdn] = 19) and placebo group (Mdn = 46) after 1 week of treatment ( U = 80, z = −5.840, P <0.001). After 3 months of treatment, PI scores were significantly different at T4 for the NBFG group (Mdn = 26.67) and placebo group (Mdn = 38.73), thus suggesting a reduction in PI scores for the NBFG group ( U = 312.5, z = −2.681, P <0.001) ( Fig 1 ).
| Time point | PI | PBI | PD | CAL | ||||
|---|---|---|---|---|---|---|---|---|
| Placebo | NBFG | Placebo | NBFG | Placebo | NBFG | Placebo | NBFG | |
| T1 | 0.09 ± 0.02 | 0.08 ± 0.14 | 0.29 ± 0.15 | 0.27 ± 0.03 | 3.40 ± 0.49 | 3.53 ± 0.49 | 0.41 ± 0.49 | 0.40 ± 0.49 |
| T2 | 0.29 ± 0.03 | 0.24 ± 0.02 | 0.24 ± 0.03 | 0.19 ± 0.01 | 3.28 ± 0.45 | 2.94 ± 0.55 | 0.37 ± 0.48 | 0.38 ± 0.45 |
| T3 | 0.46 ± 0.03 | 0.29 ± 0.04 | 0.33 ± 0.04 | 0.18 ± 0.02 | 3.06 ± 1.43 | 2.86 ± 0.56 | 0.38 ± 0.57 | 0.36 ± 0.47 |
| T4 | 0.49 ± 0.28 | 0.23 ± 0.15 | 0.37 ± 0.06 | 0.13 ± 0.04 | 3.12 ± 0.89 | 2.46 ± 0.88 | 0.39 ± 0.59 | 0.30 ± 0.58 |
