Comparing the Efficacy of Triclosan Coated Sutures versus Chlorhexidine Coated Sutures in Preventing Surgical Site Infection after Removal of Impacted Mandibular Third Molar

The aim of this present clinical trial study is evaluate the efficacy of triclosan coated sutures versus chlorhexidine coated sutures in preventing surgical site infection after removal of an impacted mandibular third molar. This prospective, single blind study included 30 patients divided into two groups with 15 patients each who had been referred to the Oral Surgery Clinic at Department of Oral and Maxillofacial Surgery, Saveetha Dental College, Chennai for surgical removal of impacted mandibular third molar under local anaesthesia. The patients were randomly assigned to two groups: Group 1 were treated with (3-0) antimicrobial triclosan impregnated polyglactin sutures for closure and in group 2 with (3–0) antimicrobial chlorhexidine diacetate-impregnated polyglactin sutures. Evaluation in regard to infection rate, abnormal erythema, pain and trismus between two groups was done on the 7th day postoperatively. In this study we observed that no significant difference in rates of infection between the groups. Abnormal erythema and trismus showed better Original Research Article Krishnan et al.; JPRI, 32(19): 138-148, 2020; Article no.JPRI.59829 139 results in group 2(chlorhexidine group) on 7th day postoperatively whereas incidence of pain was higher in patients treated with chlorhexidine coated sutures on the 7th day postoperatively as compared to patients treated with triclosan coated sutures. However, P value was >0.05 which was considered statistically insignificant. Within the limitations of the present study, chlorhexidine diacetate-impregnated polyglactin sutures showed reduced infection rates,erythema and trismus as compared to triclosan impregnated polyglactin sutures in healthy patients undergoing surgical removal of third molar under local anesthesia.


INTRODUCTION
Surgical site infection (SSI) remains as one of the most frequent complications after surgery [1][2][3][4] in the maxillofacial region.
Suture materials used during surgery carry risk of postoperative wound infections and associated complications like bone infection, organ abscess, bacteraemia, endocarditis, sepsis [5][6][7]. Evidence suggests that the suture knot may act as a nidus or scaffold for bacterial colonization and replication that can ultimately result in SSI [8]. It has also been hypothesized that a certain "wicking" phenomenon, occurring more frequently with braided or multifilament suture materials, could be responsible for the diffusion of the infection in the wound [9].
Various studies indicate that the incidence of postoperative infections following the surgical removal of third molar ranges from 1 to 5.8% and the routine use of antibiotics is not a necessity for the prevention of such a low incidence of infection [10]. Antibiotic resistance is currently a serious concern, and it is estimated that 6-7% of patients who are given antibiotics have some kind of adverse reaction to it [10]. But as most patients may lack confidence in their surgeon who do not prescribe antibiotics, clinicians at times are forced to prescribe antibiotics following the procedure [11].
Recent research has been focusing on avoiding bacterial colonization of sutures by using various antibacterial coating. An antibacterial coating may prevent the adherence of bacteria on medical materials but it is not possible to kill bacteria that adhere to suture materials, once a bio-film has formed [12]. The presence of antibacterial coatings on sutures is thought to prevent delay in wound healing by limiting the ability of these opportunistic microbes to adhere on the sutures [13].
Among antimicrobials, triclosan and chlorhexidine have a broad antibacterial spectrum as well as high biocompatibility indices. The search for a more appropriate suture material has resulted in various commercially available newer materials, like Triclosan, an antibacterial coated polyglactin 910 (vicryl plus*, Johnson and Johnson limited, India) and Chlorhexidine, an antibacterial coated polyglactin 910 (3-0) (PECTRYL®CS, Dolphin suture) which replace the conventional method of administering antibiotic in routine third molar surgeries and help in maximising antimicrobial benefits locally and reducing antibiotic load systemically and the complications that follow [14].
With a rich case bank established over 3 decades we have been able to publish extensively in our domain [15][16][17][18][19][20][21][22][23][24][25]. Based on this inspiration we aim to evaluate the efficacy of triclosan coated sutures versus chlorhexidine coated sutures in preventing surgical site infection after removal of an impacted mandibular third molar.

Study Setup
This randomized prospective controlled clinical study was conducted among patients reporting to the outpatient dental department of oral surgery clinic at Saveetha Dental College, Chennai during the period between June 2019-March 2020. The study population included 30 adult patients who were randomly selected and had been referred to the department of oral and maxillofacial surgery for surgical removal of impacted mandibular third molar under local anaesthesia. The sample size was divided into two groups, each consisting of 15 patients, namely: (1) Group 1: Individuals who were given antimicrobial triclosan-impregnated 3-0 polyglactin sutures in a simple interrupted fashion without any antibiotics for closure of the surgical site.
(2) Group 2: Individuals who were given antimicrobial chlorhexidine diacetateimpregnated 3-0 polyglactin sutures in a simple interrupted fashion without any antibiotics for closure of the surgical site.

Inclusion Criteria
• Patients above 18 years of age • Patients with impacted mandibular third molar with no prior signs of clinical infection or pain with adequate mouth opening • Patients with normal TMJ function • Partial or complete bony impactions of mandibular third molars.

Exclusion Criteria
• Patients who have taken antibiotics prior, in a span of 2-3 weeks for any head and neck infections or upper respiratory tract (penicillin/cephalosporin). • Patients with known allergic reactions to triclosan, chlorhexidine, beta-lactams and cephalosporins. • Patients on drugs that might alter the course of study and affect the healing of the surgical site, e.g. aspirin, NSAIDs, steroids and cytotoxic drugs. • Evidence of malnutrition or debilitation; • Coexisting conditions that may impair wound healing including acquired immunodeficiency syndrome (AIDS) • Patients lost to follow-up.
• Pregnancy and lactating mothers or oral contraceptives.
• Patients with poor oral hygiene and chronic smokers, chronic alcoholism

Procedure
All patients chosen for the study were prepared in standard aseptic conditions and the cases were operated utilising incisions and procedural steps through buccal bone guttering technique and tooth splitting as per the angulation, depth and position of the impacted mandibular third molar [26]. Following the third molar removal adequate curettage, debridement, thorough irrigation and the flaps were closed with triclosan-impregnated (3-0) polyglactin or chlorhexidine diacetate-impregnated (3-0) polyglactin.
They were given saline mouthwashes postoperatively for 7 days to be used thrice daily after the procedure.Patients were prescribed analgesics for 3 days postoperatively following which they were evaluated on 7th day after the day of surgery.

Diagnostic Criteria
Primary efficiency measure was the development of infection throughout the study period. The secondary outcome measures were abnormal erythema, trismus and pain.

Infection
Presence of purulent discharge in the extraction socket with or without swelling or pain.
Abnormal Erythema: Superficial reddening in mucosa seen as a result of injury or irritation causing dilatation of the blood capillaries. This was graded as: • 0 = absence of any signs of erythema.
• 1 = presence of redness and hyperaemia around the surgical site. • 2 = bleeding from the surgical site • 3 = ulceration of the surgical site.

Trismus
Measurement was taken before and after surgery using a ruler and assessed on 7th day postoperatively. This was graded as: • 0 = absence of any difference. • 1 = decrease, less than 10 mm compared to pre-surgery.

Pain
This was evaluated on the 7th day postoperatively using a Visual Analogue Scale(VAS).
Patients were asked to indicate their intensity of pain on a 5-level scale. The scale displayed five faces showing expressions which range from a minimum score of 1(No pain), 2 (Mild pain), 3(Moderate pain), 4(Severe pain)to score 5(Very Severe excruciating pain).This was graded as: • 0 = absence of pain.

Study Parameters
The following data were extracted for the purpose of the study:

Data Collection
The data related to the study parameters were obtained from among patients who reported to the Outpatient Department in Saveetha Dental College, Chennai from June 2019-March 2020. All assessments were done by a single examiner and the findings were reviewed and recorded by two investigators.

Statistical Analysis
The data was tabulated and analysed using IBM SPSS version 23.0 software. Non-parametric data were analysed using descriptive statistics measuring frequency and percentage.Student's t-test was used to compare variables(abnormal erythema, trismus and VAS Score 7th day post surgically) between both the groups.The significance level was set at P<0.05 with a confidence interval of 95%. Pearson's Chi Square Test was used to assess the association between incidence of wound infection between both the groups (Triclosan and Chlorhexidine) .

RESULTS AND DISCUSSION
A total of 30 patients participated in this study, with an overall 100% participation.

Age Distribution
The youngest and oldest patients were aged 18 and 50 years, respectively. The distribution of study subjects based on age revealed that most patients belonged to 21-30 years of age (46.67%) with the mean age of 25.42.

Gender Distribution
The distribution of study subjects based on gender, over a ten month period, revealed that 12 patients (40%) women and 18 patients(60%) men participated in this study.

Incidence of Infection
The incidence of infection in group 1(triclosan) was numerically 3 out of 15 cases and in group 2 (Chlorhexidine) was 2 in 15 cases as evaluated on the 7 th postoperative day. Necessary intervention was done and appropriate medications were prescribed as required. Pearson's Chi Square Test was used to assess the association between incidence of wound infection between both the groups (Triclosan and Chlorhexidine) on the 7th day postoperatively. However, this association was not statistically significant (P>0.05).

Abnormal Erythema
There was a clear difference in the values of abnormal erythema between the groups in the 7th day postoperatively with a frequency distribution of abnormal erythema(grade 1) of 20% and 6.66% in group 1 and group 2, respectively. Therefore , patients treated with triclosan coated sutures showed a higher incidence of abnormal erythema as compared to patients treated with chlorhexidine coated sutures. However, P value was 0.16 which was considered statistically insignificant.

Trismus
There was a difference between the values in case of trismus assessed 7th day postoperatively with a frequency of 73.33% of no trismus in the chlorhexidine-impregnated suture group (group 2) as compared to 66.66% in triclosanimpregnated suture group(group 1), and <10 mm difference in maximum mouth opening from preoperative values as 33.33% in group 1 and 26.66% in group 2.Therefore, patients treated with triclosan coated sutures showed a higher incidence of trismus as compared to patients treated with chlorhexidine coated sutures. However, P value was >0.05 which was considered statistically insignificant.

Pain Evaluated by VAS Score
On the 7th day postoperatively, there was amelioration of pain in either group and only one candidate(6.66%) in group 1 and two candidates(13.33%) in group 2 showed VAS score >5. Therefore, patients treated with chlorhexidine coated sutures showed a higher incidence of pain as compared to patients treated with triclosan coated sutures. However, P value was >0.05 which was considered statistically insignificant. Smart sutures are materials which are covered with temperature sensors and micro-heaters and can detect infections. If they are coated with antibacterial drugs, they might be highly effective in prevention of SSIs [27]. Inspite of many controversial results amongst different clinical studies, the antimicrobial suture have proven to be more or less effective in decreasing the risk for postoperative SSIs in the maxillofacial region.
Physical properties and configuration of suture materials influence the degree of surgical site infection [28]. Triclosan is effective in significantly reducing the bacterial adherence to suture material which can decrease the SSI and morbidity [13]. The safety of triclosan is well established proving that it doesn't possess carcinogenic or sensitization potential [29]. Triclosan is an antiseptic component with bacteriostatic action. At low concentrations, inhibits the growth of many non sporulating gram positive and gram negative bacterial species [30]. The active component in coated polyglactin 910 suture with triclosan is Irgacare MP (triclosan), a broad-spectrum antiseptic agent that has been shown to be efficacious against these putative pathogens without inducing resistance [31][32][33].
Chlorhexidine is a widely used antimicrobial in various forms. It has shown high anti-infective efficacy in several studies involving orthopaedic [34], obstetric [35], surgical [36] and dental applications [37]. Chlorhexidine diacetate is a bisbiguanide compound with a rapid bactericidal activity against both gram-positive and gramnegative organisms. The antibacterial effect of chlorhexidine is related to its action on the bacterial cell membrane and precipitation of intracellular contents configuring it with both bactericidal and bacteriostatic properties [38].
In our study, the incidence of infection in group 1(triclosan) was numerically 3 out of 15 cases and in group 2 (Chlorhexidine) was 2 in 15 cases as evaluated on the 7th postoperative day. This was in accordance with the study by Mohan et al. [14] and Gazivoda et al.
[39] and Venema et al. [40]. According to a review study by Zeitler et al., [10] the use of antibiotics tend to show little improvement in trismus. According to the study by Mohan et al. [14] follow up visits showed no statistical difference in patients treated with prophylactic antibiotics compared to those treated with chlorhexidine sutures in relation to trismus. This was in accordance with our study.
There seemed to also be a slight difference in values of abnormal erythema between the groups. According to a study Obermeier et al [41], the chlorhexidine laurate coating (CL11) molecularly similar to chlorhexidine diacetate which is chlorhexidine palmitate, best meets the medical requirements for a fast bacterial eradication. It also has a high drug release during the first clinically most relevant 48 h with a good biocompatibility. The lower incidence of erythema (6.66%)in the chlorhexidine group on the 7th day postoperatively, could be attributed to this reason which resulted in prevention of biofilm formation over the suture material. However, the difference was not statistically significant which was in accordance to the study by [14] and Ford et al. [8].
The postsurgical pain begins when the effect of the local anaesthesia subsides and reaches peak levels in 6-12 h postoperatively [42]. In our study, the patients were prescribed analgesics pain control for the next 3 days postoperatively. On the 7th day postoperatively, there be a slightly higher incidence of chlorhexidine group (13.33%) as the triclosan group which was in accordance the study by Tae et al., [43]. However,

FUTURE SCOPE
Triclosan impregnated polyglactin sutures and chlorhexidine diacetate-impregnated polyglactin sutures have both been introduced recently in the field of dentistry with no adverse effects being documented. However, the use of chlorhexidine sutures show properties closer to an ideal suture material in comparison to triclosan sutures.

LIMITATIONS
Future clinical studies with larger sample sizes are needed to accurately compare and evaluate the efficacy of triclosan impregnated sutures with chlorhexidine impregnated sutures in minor oral surgical procedures.

CONCLUSION
Within the limits of this study,it can be concluded that both triclosan and chlorhexidine impregnated polyglactin sutures have a significant ability in preventing surgical site infection. However, chlorhexidine sutures showed reduced infection rates, erythema and trismus as compared to triclosan sutures in healthy patients undergoing surgical removal of third molar under local anesthesia. Therefore, their use in various intraoral procedures for effective control of inflammatory and infectious conditions should be highlighted.

CONSENT AND ETHICAL APPROVAL
Approval for the study was obtained from the Institutional Ethical Committee of Saveetha University (SDC/SIHEC/2020/DIASDATA/0619-0320). Informed consent was obtained from the patients.