A comparative evaluation of effect of nano-bio fusion gel and chlorhexidine Gel in patients with chronic periodontitis: A clinical study

Introduction

Inflammatory reaction in the periodontium causes periodontitis which may lead loss of the supporting structure around the tooth. Interaction between bacteria and gingival lining results in inflammation and destruction of the connective tissue attachment of the disease which leads to the migration of the epithelial lining, deepening of pockets and loosening of teeth due to loss of alveolar bone.1

Treatment of periodontal diseases includes open flap debridement but not every patient undergo surgical therapy. Studies have shown effective results with systemic delivery of antibiotics. These systemic antibiotics can lead to further harm to overall health of the patient, antibiotic resistance, gastrointestinal intolerance are some of the complication. To overcome this, application of local drug delivery came into existence.2

One such local drug delivery agent is chlorhexidine which is an effective antimicrobial agent. It was firstly used by Friedman and Golomb,3 as a topical agent in sustained released dosage form. This form of CHX gel had shown effective results in reducing the PPD, CAL and BOP.4

Even though traditional antimicrobial agents have produced results that are similar, researchers are constantly looking for alternative treatments for chronic periodontitis. For the therapy of periodontitis, a variety of agents with antibacterial, antioxidant, and anti-inflammatory properties have been used up until now. The use of herbal and natural goods are safer than synthetic ones. Periodontal diseases have been effectively treated with the adjunctive use of herbal and animal-based products.5

Nano-Bio Fusion (NBF) gingival gel is an antioxidant gel composed of propolis, vitamin C and E. Its mechanism of action is based on its nano antioxidant particles.6 Propolis present in the gel is a natural material produced by honey bee and is available in different formulation for use in different filed of medicines. Vitamin C present in the gel helps in repair and rejuvenating the tissue.7 Vitamin E in the gel plays an important role to eradicate free radical and to protect cells from lipid peroxidation. All these materials work in synergy to maintain the integrity of the cell.8

Aims and Objectives

The aim and objectives of this clinical study is to compare the clinical effectiveness of Nano Bio Fusion gingival gel and Chlorhexidine gel as an adjunct to SRP in chronic periodontitis patients.

Materials and Methods

The study was done in the Department of Periodontology, Seema Dental College and Hospital, Rishikesh, Uttarakhand, with the approval of the ethical committee. The subjects were selected from out-patient department and each patient was given detailed verbal and written description of the risk and benefit of the treatment with the consent to treatment agreement. Systemically healthy patients, age 25-60 years, with no history of any periodontal therapy within the last 6 months were selected for the study. Patients with moderate to severe periodontitis with PPD of ≥ 5mm and clinical attachment loss were included. All the patients were instructed to follow standard oral hygiene measures. Pregnant female patients or lactating mothers, patients having history of consuming tobacco in any form and/or smoking, patients having allergic reaction or hypersensitivity to any product used in the study and patients on any antibiotic therapy/ antimicrobial mouth rinses were excluded from the study.

Figure 1

Nano bio fusion gel

Figure 2

Chlorhexidine gel

Study design

A total of 45 study subjects were randomly assigned into three groups. In Group A (15): application of NBG gingival gel (Fig 1) after phase 1 periodontal therapy. Group B (15): application of chlorhexidine gel (Fig 2) in pockets site after NSPT and in group C only scaling and root planning was done. Plaque index (PI), gingival index (GI), modified sulcular bleeding index (mSBI), probing pocket depth (PPD) and clinical attachment level (CAL) were recorded at baseline, 1 month and 3 months.

Figure 3

NBF gel (Group A); A): Pre-operative picture, B): Application of NBF gel, C): After 1 month, D): After 3 months

Figure 4

Chlorhexidine Gel (Group B); A): Pre-operative picture, B): Application of Chlor-X gel, C): After 1 month, D): After 3 months

Figure 5

Group C (only SRP); A): Pre-operative picture, B): After 1 month, C): After 3 months

Results

The demographic details of the participants enrolled for the study in group A, B, and C are summarized in Figure 6, Figure 7, Figure 8. Group A consists of 15 patients (9 males and 6 females). Group B consists of 15 patients (6 males and 9 females). Group C consists of 15 patients (9 males and 6 females). The overall mean age was 36.4±0.87 with 53.3% males and 46.7% females.

Intergroup comparison of plaque index showed statistically significant difference at baseline and at 1 month between group A and B. On intergroup comparison of gingival index all the groups showed statistically significant results at baseline. Intragroup comparison of group A, B and C showed statistically significant results at 1 month and 3 months. Intergroup comparison of modified sulcular bleeding index showed statistically significant difference among group A and B at baseline, 1 and 3 months. Group A and C showed significant difference at 1 month. Intergroup comparison of probing pocket depth showed significant difference between group A and C at 1 month only. (Table 1, Table 2, Table 3, Table 4, Table 5)

Intragroup comparison of plaque index scores differed significantly across three time points for Group A (F=20.808, p=.000), Group B (F=21.563, p=0.000), Group C (F=16.657, p=0.000), Gingival Index for Group A (F=5.269, p=.009), Group B (F=5.260, p=0.009), Group C (F=4.307, p=0.020), Modified Sulcus Bleeding Index scores for Group A (F=14.825, p=.000), Group B (F=1.525, p=0.229), Group C (F=2.494, p=0.095). Probing Pocket Depth scores differed non significantly across three time points for Group A (F=1.277, p=0.289), Group B (F=0.307, p=0.737), Group C (F=0.609, p=0.549) and Clinical Attachment Loss scores differed significantly across three time points for Group A (F=0.450, p=.641), Group B (F=3.846, p=0.029), Group C (F=1.295, p=0.285). A post hoc analysis using Tukeys HSD test was done to assess the significant difference between different time interval for all the parameters. (Table 6, Table 7, Table 8, Table 9, Table 10)

Graph 1

Total number of patients

Graph 2

Gender wise distribution of patients

Graph 3

Mean age of patients

Discussion

CHX have both bacteriostatic as well as bactericidal activity. It is effective against gram-positive, gram-negative bacteria, fungi and yeast. It is a gold standard and have shown decrease in bacterial count when subgingival application is done in periodontal pockets.9

Nano bio fusion gel is an antioxidant gel which has beneficial effects on regulation of fibroblasts proliferation during gingival and periodontal healing. NBF gel is the first product that contains nano-oxidants and is produced using nano-bio fusion technology. The gel is characterized with its instant absorption by gums. It is a high functional paste comprising of 3 main ingredients: Vitamin C, E and propolis extract in a nano-emulsion state. The gel is biocompatible patented nano-emulsion form having antibacterial, anti-inflammatory and anti-oxidative effect.10

On intergroup comparison a statistically significant result was observed between Group A and Group B at 1 month. This reduced plaque score could be due to patient’s compliance towards oral hygiene instructions, maintenance and thoroughness of SRP.11

Intragroup comparisons of gingival index from baseline to 1 month showed a statistically significant result, whereas a statistically non-significant result was observed from 1 month to 3 months for all the groups. This was similar with the findings by Srivastava V et al (2019)12 and Goswami V et al. (2022).13

The possible mechanism behind this can be the presence of caffeic acid phenethylester in propolis. Propolis has shown to activate thymus gland and aids the immune system by activating phagocytic activity, and enhances the healing effects of epithelial tissues.14

Intergroup comparison showed significant difference between Group A and Group B and Group A and Group C at baseline, 1 month and 3 months. Modified sulcus bleeding index on intra group comparison showed statistically significant results from baseline to 1 month and 3 months only for test group.

This was similar to the study done by Debnath K et al (2016)15 in which the evaluation NBF gel as an adjunctive therapy to SRP for treatment of chronic periodontitis was done on clinical and microbiological findings. This can be because propolis has as anti-inflammatory agent which inhibit the synthesis of prostaglandins and facilitate healing effect on epithelial tissues.16

Intergroup comparison showed statistically significant difference between groups A and B at baseline, 1 month and 3 months. Group A and group C showed statistically significant result only at 1 month. PPD showed statistically significant result between group A and C at 1 and 3 months when intergroup comparison was made.

This was similar to the study done by Srivastava V et al. (2019),12 Patil AV et al. (2020)17 in which they compared the clinical effectiveness of NBF gel as an adjunct to phase 1 periodontal therapy. NBF gel uses nano dimensions between 1 to 100 nanometres to deliver the properties of the drugs into the target site with better penetration. This property of NBF gel have been effective against gingival and periodontal diaseases.18

The intergroup comparison between group B and group C was non significant. However, a study done by Jain M et al (2013)19 reported a significant difference at 3 and 6 months when chlorhexidine was administered into the periodontal pockets.

Intragroup comparison of group B showed statistically significant result for CAL at baseline and 1 month only. This was similar to the results found by Ahmad BZ (2020)20 in which the effectiveness of locally delivered chlorhexidine gel was compared as an adjunct to SRP for the treatment of chronic periodontitis.

Chlorhexidine in gel form has mucoadhesive properties; therefore, it adheres to the pocket lining and is not eliminated by oral fluids. That’s why they are more effective that in irrigation form.21

The intergroup comparison between group B and group C was found non significant. This was in accordance with the study done by Sivadas A et al. (2021)22 in which they compared topical chlorhexidine gluconate gel and povidine-iodine ointment as an adjunct to phase 1 therapy. The results of this study were statistically non significant when SRP was compared with CHX group in terms of clinical attachment gain.

Conclusion

It can be concluded that, nano bio fusion gingival gel and chlorhexidine gel can be a good adjunct to SRP for the treating chronic periodontitis. All the clinical parameters measured were reduced from baseline to 1 month and 3 months.

However, more studies with a larger sample size may be used to evaluate the potential of these local drug delivery agents. Also, a longer follow up can be done to evaluate the outcomes with respect to periodontal tissues. Microbiological assessment can also be done to access the action of periodontopathogens.

Source of Funding

None.

Conflict of Interest

None.