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Clinical and patient‐centered outcomes post non‐surgical periodontal therapy with the use of a non‐injectable anesthetic product: A randomized clinical study

Abstract Aim The aim of this study was to determine the impact of different full‐mouth decontamination (FMD) protocols on the effectiveness of an intrapocket anesthetic gel in periodontal maintenance patients. Methods Patients undergoing the periodontal maintenance program and with the need for FMD participated in this study. Patients were randomly allocated to non‐surgical periodontal therapy (NSPT) with either a preparatory 15‐day decontamination phase, including chlorhexidine mouth rinse and domiciliary hygiene instructions (modified FMD: test group), or without it (FMD: control group). In both groups, NSPT was performed with the aid of a non‐injectable anesthetic gel. Clinical and patient‐related outcomes were recorded during a 6‐month follow‐up period. Results Sixty patients completed the 6‐month study. Both groups experienced relevant clinical improvements after NSPT, but the test group showed a significant change in periodontal parameters already after the initial 15‐day preparatory period, and overall significantly better results in periodontal outcomes when compared with the control group at the last 6‐month follow up: the gingival index was 2.07 ± 1.25 in the control group and 1.13 ± 0.51 in the test group. Less pain and dental‐related anxiety were perceived by patients in the test group showing a 6‐month mean visual analog scale of 2.13 ± 1.25 in the control group and 1.13 ± 0.83 in the test group. Conclusion The present study suggested that the modification of the standard FMD could improve the clinical efficacy of non‐injectable anesthetic, along with patients’ short‐ and mid‐term appreciation and compliance.

questioned, as some studies have failed to show additional benefits even after extended use. As a matter of fact, after SRP, CHX should be time-limited and soon replaced by proactive therapy. The use of CHX for longer than 15 days is unnecessary because of undesirable side-effects such as staining, taste disruption and/or local microbiome derangement. 12 Regardless of the protocol, SPT has often been associated with pain and discomfort of the patient. 13 Notably, the response to pain varies greatly from person to person and it is often modulated by the level of local inflammation and by individual patient arousal (level of anxiety and apprehension). 14 Nevertheless, local injection anesthetic for pain control before NSPT is not often welcomed by all patients, preventing actual delivery of FMD in some cases.
A large study based on an international telephone survey found that participants considered local anesthetic injection as painful, and 1/3rd would rather accept some discomfort during the periodontal procedure vs being subjected to an injection. 15 Clinical efficacy and patients' acceptance of anesthetic gels prior to SRP is described in the literature. 16 Patients claimed to be willing to pay an additional amount of money to cover the expense of the anesthetic gel. The greatest advantage of non-injectable gels is reduced postoperative numbness and discomfort when compared with injectable anesthetic. Furthermore, it is reported that patients are more willing to return for recall visits if the gel is available at the office. 17 Finally, non-injectable anesthetic is time-efficient, thus being in both the patient's and clinician's interest. However, little is known about the ideal working conditions of this medicament.
The null hypothesis of the present study would have been that there were no differences in terms of gel anesthetic effectiveness depending on the type of FMD protocol used. The aim was to investigate whether a preparatory period aiming at reducing the initial local inflammation could have influenced the perceived performance of a non-injectable anesthetic (Oraqix ® ; Dentsply, Konstanz, Germany).

| Study design
A randomized, prospective, parallel study design was adopted.
Eligible patients were recruited from those attending the Tuscan Stomatologic Institute for standard non-surgical periodontal treatment (NSPT). The local ethics committee gave the approval for this study.

| Patient selection criteria
The inclusion criteria were as follows: age of 18 years or older; patients scheduled for NSPT with injection anesthetic; and patients of good general health. Subjects exhibiting 1 of the following criteria were excluded from the study: history of hypersensitivity to lidocaine, prilocaine or local anesthetic of the amide type, or to any excipients in the preparation; severe hepatic disease; diabetes; congenital or idiopathic methemoglobinemia; pregnancy or lactation; and having received periodontitis treatment within the 6 months prior to start of the study.
Those satisfying the inclusion criteria were asked to fill out an anamnestic questionnaire, covering participants' age, gender, tobacco consumption and continuative drug intake. All eligible participants were assigned a consecutive study number. Patients were randomly allocated to 1 of 2 possible groups of treatment through a computergenerated list (see below). Sample size estimation was calculated to achieve a significant difference in the intra-and intergroup analysis in periodontal parameters and patient-related outcomes. 20

| Group 1 or test group
At baseline, patients allocated to the test group received standardized instructions regarding the home-based disinfection protocol.

| Group 2 or control group
At baseline, periodontal non-surgical treatment was performed immediately, with no attempts to reduce existing conditions prior to therapy. After SRP, patients were instructed exactly as per the test group. The standard non-surgical FMSRP was delivered following the application of Oraqix on each quadrant, as per the manufacturer's instructions, in 1 sitting,

| Follow up
Patients were evaluated at baseline, and at 15 days, 30 days, 90 days and 6 months after NSPT.

| Periodontal treatment
In this study, NSPT consisted of removal of plaque and calculus utilizing sharp mini-curettes and ultrasonic inserts until the surfaces were hard and smooth. Before SRP, patients in both groups received Oraqix, a topical anesthetic agent used in periodontal treatments for pain control. It consists of a eutectic mixture of 5% lidocaine and prilocaine (each gram contains 25 mg lidocaine and 25 mg prilocaine). The teeth were isolated with cotton rolls or lip separators and the pockets were dried with paper points in order to soak up the crevicular fluid, maximizing the substantivity of the gel applied. Oraqix was placed inside the periodontal pockets from distal to mesial using a plunger/applicator designed for such purpose. When re-anesthetic was needed, the clinician placed more Oraqix on the sensitive area (not to exceed 5 vials in total) and recorded the quantity and number of vials used.
No analgesic or anti-inflammatory drugs were prescribed in this study in order to evaluate the effects of treatments exclusively.

| Psychological assessment
Before clinical examination, 2 psychological instruments were administered to the participants. The dental anxiety score (proposed by Corah in 1969) 18 is a survey of 4 questions directly related to dental anxiety: (a) "If you were to go to the dentist tomorrow, how would you feel?"; (b) "While you wait in the office, how do you feel?"; (c) "While you are in the dentist's chair waiting for him/her to take the drill to start work on your teeth, how do you feel?"; and (d) "You are in the dentist's chair to clean your teeth. How do you feel while the dentist takes the instruments to clean your teeth?". Each question has 5 choices of answer, and the final score can range 4-20. The dental fear score (proposed by Kleinknecht and Klepac in 1973) 19 is an instrument to assess dental fear and attempts to avoid treatment. It is a Likert-like questionnaire consisting of 20 items that assess issues related to the avoidance of treatment, somatic visceral excitement and how much fear is caused by the stimuli associated with dental treatment. The score for each question ranges from 1 (little fear) to 5 (very afraid), the total range being 20-100, with positive correlation to increasing dental fear.
Within 5 minutes after treatment, patients were presented the following question: "How much pain did you feel during the SRP procedure?". Each patient received a postoperative pain sheet with a visual analog scale (VAS). 21 The VAS used was a continuous scale comprised of a horizontal line, measuring 100 mm in length, anchored by 2 verbal descriptors, 1 for each symptom extreme: "no pain" at the far left (score of 0) and "pain as bad as it could be" or "worst imaginable pain" at the far right (score of 100). The respondent was instructed to mark the point that represented the pain intensity.

| Statistical analysis
Descriptive, difference and correlation analysis was performed  Abbreviations: FMD, full-mouth decontamination; MFMD, modified full-mouth decontamination.

| Anesthetic vial proportion
The non-injectable anesthetic product quantity used was expressed in vial quarters. A mean of 2 vials were necessary for patients in the control group whereas 1 vial was sufficient for patients in the test group ( Figure 1).

| Clinical assessment
Mean and standard deviations for each parameter explored are presented in Tables 2 and 3

| Patient-related outcomes
There was a significant interaction between treatment groups and time on patient-related outcomes (VAS, DAS, DFS) demonstrated with each test within the f1.ld.f1 function. Patients in the test group showed the lowest scores for pain, dental anxiety and treatment avoidance over time when compared with the control group (P < .0001) ( Table 5).
In the kernel regression univariate analysis, postoperative pain was significantly associated with severe periodontal inflammation (r 2 = .3492695) and dental anxiety (r 2 = .6482695).

| D ISCUSS I ON
Non-surgical periodontal treatment by means of SRP is considered to be the basis of periodontal maintenance and therapy. 23 The results of the present study suggested that the MFMD is a valid way to approach SRP and that it is associated with great patient acceptance. Patient-related outcomes turned out to be better for It has been suggested by Schirmer et al that post-NSPT pain is associated with dental anxiety and baseline inflammation. 14 In their study, the prevalence of pain after NSPT with local anesthetic was higher for patients with severe periodontal inflammation, defined as the presence of at least 4 sites with a probing depth of 6 mm or more. though the microbiota is almost suppressed by CHX, the microbiota spontaneously return to that observed after mechanical means alone. 26 This reinforces the notion that the microenvironment is critical in controlling the actual bacterial composition of the local microbiome, and that the microbiota will tend to return to that characteristic of the specific individual, once antimicrobial means are withdrawn. 27 The patients' perceived experience is a fundamental component of the global effect of full-mouth NSPT. In fact, the negative experience of dental anxiety results in greater avoidance of, and delay in, dental hygiene appointments, resulting in deteriorated oral health with higher treatment needs and costs, with the potential loss of further patient attendance at the dental office. 28 The modified FMD supports the modern tendency towards patient-centered approaches with the patient becoming a proactive part of a long-term preventive therapy. Therefore, the true benefit of the 15-day preparatory period is likely the impetus of the patients' understanding of, and compliance with, therapy.
Sekino et al rejected the hypothesis that the FMD protocol could generate greater anxiety and pain, and that the severity of periodontitis increases pain, fear and anxiety scores. 25  In conclusion, this study suggested that the MFMD protocol combined with the application of an anesthetic gel immediately before SRP allows for time-efficient non-surgical therapy with overall improved clinical parameters, less use of medication, reduced dental anxiety and greater patient acceptance.

CO N FLI C T O F I NTE R E S T
None declared.