Efficacy of irrigation with different antimicrobial agents on periodontal health in patients treated for chronic periodontitis: A randomized controlled clinical trial

Introduction

The periodontium is highly vulnerable to disease processes. Bacterial plaque and their biologically active products have been implicated as the primary etiologic agents of periodontal disease.[12] These microorganisms damage the tissues by releasing various toxins, enzymes, and metabolic products which are considered important in the causation of the gingivitis and periodontitis.[3]

Subgingival microbiota harbors more than 200 bacterial species.[4] Many of which have periodontal pocket as their main habitat. The appearance of subgingival pathogenic Gram-negative microbial flora is undoubtedly related to anaerobic environment inherent in pockets that facilitate proliferation of such microorganisms.[5]

Studies report that supragingival hygiene aids do not totally eliminate periodontal inflammation.[67] It has been shown to be virtually impossible to remove subgingival plaque by routine brushing and flossing. Similarly, direct irrigation with the mouthwash failed to reach in the pocket. To overcome these problems, root planning, surgery, and local and systemic antimicrobial agents have been employed to facilitate the elimination of pocket microflora.

In the recent past, attention has recently been focused on the methods of localized drug delivery. Pulsating irrigation device is very helpful in delivering the drug to the base of the pocket. Various studies have shown improved results when pulsating irrigation device is compared with mouth rinse in reducing gingival inflammation.[8910] Chlorhexidine (CHX) is considered a “gold standard” antibacterial solution and is extensively used as a mouthwash and irrigating solution. However, it has certain side effects after prolonged uses such as loss of taste sensation, staining of the teeth, calculus formation, and in some cases, parotid swelling is observed.

Recently, various herbal extracts (HEs) have been tried as mouthwash and irrigating solution with the promising result. Being herbal products, they do not cause much side effects and thus can be used safely. The results of the previous study have suggested that the dental gel containing Azadirachta indica Linn. (Neem) extract has significantly reduced the plaque index (PI) and bacterial count than that of the control group (0.2% CHX).[11] A study suggested that the herbal preparation proved more effective than a conventional mouthwash at reducing gingival inflammation.[12]

Hence, in this study, an attempt is made to assess the efficacy of different antimicrobial agents (CHX vs. HE) on periodontal health in patients who have been treated for chronic periodontitis and still have residual pocket of around 3–5 mm after scaling and root planing (SRP).

Materials and Methods

A total of 30 systemically healthy patients with chronic periodontitis (after diagnosis and before full mouth prophylaxis) were recruited from the pool of patients who visited the Department of Periodontology and Implantology. Ethical clearance has been obtained from the Institutional Ethical Committee (M.G.V. Dental College and Hospital, Maharashtra University of Health Sciences) before the commencement of the research work. Informed written consent was obtained from the patients before starting the study.

Grouping and posology

This was a controlled, single-blind, randomized study for 3 months. Patients (n = 30) were randomly assigned by simple randomization (coin test) in control group and test group.

In control group, commercially available 0.2% CHX Hexidine^® (ICPA Health Products Ltd., Maharashtra, India) was administered. Whereas in test group, HE consisting of Punica granatum Linn. (pomegranate - fruit rind), Piper nigrum Linn. (black pepper), and detoxified copper sulfate [Figure 1] was administered. Both fluids were used for the irrigation of residual pockets using pulsated irrigating device, WaterPik^® (Dentos India Private Ltd., Mumbai, Maharashtra, India) [Figure 1].

Figure 1

Raw herbal product collected from market

Patients were subjected to SRP. After 1 month, SRP patients who fulfilled the inclusion and exclusion criteria were included into the study. The irrigation was performed in each individual as a demonstration. Irrigation device was dispensed to the patient with specific group with the verbal and written instruction. Patients in both the groups were asked to irrigate with the respective solution twice daily after tooth brushing [Figure 2].

Figure 2

Irrigation device while delivering irrigating solution at gingival margin

Test drug

Initially, raw materials were collected from the market; dried peel of P. granatum Linn., edible P. nigrum Linn., crystals of copper sulfate [Figure 3]. Before preparing fine powder, copper sulfate was detoxified by roasting it at 65–70°C for 15 min. Then, the amount to be used in the single irrigating mouthwash was calculated from the previous Unani paste and powder formulation and multiplied by the dosage. Formulation for a single dose of irrigation derived from the National Formulary of Unani Medicine.[13]

• P. granatum Linn.: 3000 mg (3 g)

• P. nigrum Linn.: 1250 mg (1.25 g)

• Copper sulfate: 60 mg (0.6 g).

Figure 3

Irrigating solutions (herbal extract, chlorhexidine) with irrigating device

After that, a machined fine powder was prepared from the entire components. Aqueous extract was prepared by dissolving each component separately in distilled water for about 1 h and then filtration was done to remove any solid particles from the solution. They were then mixed to from a single solution for irrigation. WaterPik model no. WP-360 E2 with a reservoir capacity of 150 ml was used with the tip for irrigation at a pressure of 60 psi.

Observations and Results

Consort flow chart exhibiting the numbers of subject finally analyzed and those dropped out have been described [Figure 4]. Thirty patients completed the study, out of which 14 were male and 16 were female.

Figure 4

Study flow chart

The results show that SRP and CHX + irrigation and SRP with HE + irrigation are effective for treating chronic periodontitis. Irrigation with HE shows more reduction of PI when compared to irrigation with the CHX group [Table 1]. While comparing SBI, irrigation with CHX shows a better result over irrigation with HE at an interval of 30, 60, and 90 days [Table 2]. Other parameters such as probing pocket depth (PPD) and microbiological counting were same for both the groups [Tables 3 and 4]. All the parameters in both the groups show a greater reduction at 15 days which remain stable up to 90 days.

Table 1

Mean difference in plaque index

Table 2

Mean difference in sulcus bleeding index

Table 3

Mean difference in probing pocket depth

Table 4

Mean difference in number of spirochetes

Discussion

Specific bacterial plaques and their biologically active products have been implicated as the primary etiologic agents of periodontal disease.[16] Periodontal therapy centers around the removal and control of plaque and the restoration of a normal bacterial flora in the gingival sulcus.[8] Treatment of periodontal disease is routinely based on oral hygiene procedures and root debridement, which reduces the periodontal bacteria.[17]

The successful long-term management of periodontitis requires a proper maintenance of the results obtained after treatment.[17] This can be successfully done with the adjunctive use of antimicrobials.[18] Subgingival irrigation with a chemotherapeutic agent, when delivered with an irrigation device, may be a beneficial adjunctive modalit[19]

In this study, we were able to manage moderate cases, which may have needed surgical treatment, by noninvasive procedure using local drug delivery. The primary objective of clinical trial was comparison between SRP and CHX irrigation (control group) and SRP and HE irrigation (test group).

CHX was selected as control group because of its antiplaque effect, which was proved by the study.[20] HE was used because P. granatum was evaluated for its antimicrobial activity against oral pathogens, and preliminary results have shown that it has the potential to be used to prevent periodontal diseases. Likewise, P. nigrum was evaluated for antibacterial activity in various studies and it has been shown that it has good antibacterial activity against Gram-positive and Gram-negative organisms.[21] Copper sulfate is not extensively studied for periodontal disease, but various Unani and Ayurvedic formulations have used it because of its astringent and antiseptic effect.[1322]

In this study, both test and control groups showed a decrease in all the parameters when compared from baseline to 90 days. Intergroup comparison showed no significant change in all parameters except PI in which test group showed more reduction than control group when compared from baseline to 90 days.

Conclusion

Irrigation with HE is a simple, safe, and noninvasive technique and no serious adverse effects were recorded with the product. It reduces the percentage of microorganism in periodontal pocket. These short-term data reveal that the patients can be stabilized with the irrigation with both HE and CHX. Future research with large sample size and extended follow-up period should evaluate the long-term effect of regular application of HE.

In the future, mechanism of action of HE in plaque reduction and its substantivity needs to be evaluated and documented. The use of these products in oral hygiene maintenance needs to be encouraged.