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ORIGINAL ARTICLE
Year : 2017  |  Volume : 20  |  Issue : 9  |  Page : 1189-1194

Impact of oral antibiotics on health-related quality of life after mandibular third molar surgery: An observational study


1 Department of Dental and Maxillofacial Surgery, Usmanu Danfodio University Teaching Hospital, Sokoto, Nigeria
2 Department of Oral and Maxillofacial Surgery and Oral Pathology, Obafemi Awolowo University Teaching Hospitals Complex, Ile-Ife, Osun State, Nigeria

Date of Acceptance16-Apr-2016
Date of Web Publication26-Oct-2017

Correspondence Address:
R O Braimah
Department of Dental and Maxillofacial Surgery, Usmanu Danfodio University Teaching Hospital, Sokoto
Nigeria
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/1119-3077.183235

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   Abstract 

Aim: To compare the impact of antibiotics on health-related quality of life (QoL) outcomes following third molar surgery. Materials and Methods: The study population consisted of 135 subjects that required surgical extraction of mandibular third molar under local anesthesia and met the inclusion criteria. The subjects were randomized into three study groups of 45 subjects each: Group A - extended amoxicillin/clavulanic acid (GlaxoSmithKline Beecham England), 1 gram pre-operatively and then 625 mg BD for 5 days Group B - prophylactic amoxicillin/clavulanic acid (GlaxoSmithKline Beecham England) 1 gram pre-operatively only, and Group C - prophylactic levofloxacin 1 gram pre-operatively only. Patients were assessed pre- and post-operatively on days 1, 3, 5, 7, and 14 using the United Kingdom oral health-related QoL (OHRQoL) questionnaire. Results: This study showed that surgical removal of impacted teeth exerted a negative influence on patient's QoL across various physical, social, and psychological aspects of life. Comparing the three groups, Group A showed a slightly better QoL score; although, there was no statistically significant difference among them. Studies have shown better clinical recovery following administration of antibiotics after third molar surgery. Conclusion: There was a significant deterioration in OHRQoL in the immediate postoperative period, particularly postoperative days 1 and 3 following third molar surgery. QoL was also observed to be slightly better in Group A than Groups B and C, although this was not statistically significant.

Keywords: Amoxicillin/clavulanic acid, antibiotic prophylaxis, levofloxacin, quality of life, third molar surgery


How to cite this article:
Braimah R O, Ndukwe K C, Owotade J F, Aregbesola S B. Impact of oral antibiotics on health-related quality of life after mandibular third molar surgery: An observational study. Niger J Clin Pract 2017;20:1189-94

How to cite this URL:
Braimah R O, Ndukwe K C, Owotade J F, Aregbesola S B. Impact of oral antibiotics on health-related quality of life after mandibular third molar surgery: An observational study. Niger J Clin Pract [serial online] 2017 [cited 2020 Jan 26];20:1189-94. Available from: http://www.njcponline.com/text.asp?2017/20/9/1189/183235


   Introduction Top


The impact of oral diseases and oral procedures on quality of life (QoL) is very obvious following third molar surgery.[1] Problems created by the disturbances in postextraction wound healing and physiologic sequelae of third molar surgery can significantly affect the patient's QoL.[1],[2] Before consenting to surgery, patients are informed of the risks and benefits of having their third molars removed. Most of the information available to both clinicians and patients focuses on clinical outcomes.[3] Although this information is important, patients want to know about the surgical procedure and expectations during recovery. Interestingly, there has been increasing calls for greater understanding of the effects of third molar removal on patients' day-to-day living, as there are few such studies published.[4]

It is important to understand levels of presurgical morbidity typically experienced by patients so that clinicians can inform patients about the types of expected impacts on daily life if patients have symptoms and choose to forego or delay treatment. Furthermore, the severity of any presurgical morbidity may help clinicians and patients select treatment alternatives in circumstances where clinical indicators alone do not provide clear-cut information of whether to proceed with surgery. For example, patients whose QoL is adversely affected by presurgical conditions may elect to have surgery, even when clinical criteria suggest that surgery and conservative management could be equally effective. Finally, if there is additional information about the impact of the surgery on QoL, clinicians can advise patients about the expected levels of morbidity that can be anticipated during recovery relative to their presurgical morbidity.

The topic of preventive antibiotic administration in third molar surgery in healthy individuals is still controversial; some authors have reported the need for such method.[5],[6],[7],[8],[9] Other authors have reported a lack of efficacy.[10],[11] Merits of the appropriate use of prophylactic antibiotic include; reduction in the incidence of transient bacteremia thereby reducing postoperative patient morbidity, promptness to resume work, reduced cost of returning to the dentist, and cost effectiveness regarding buying less drugs.[12] It also reduces the total amount of antibiotics to be consumed by the population thereby minimizing the development of bacteria resistance.

More recently, a Cochrane review on the use of antibiotics in third molar removal concluded that antibiotics may be beneficial following removal of the third molar in diseased gum and severely decayed tooth.[13]

The purpose of this study was to examine the impact of oral antibiotics administered as single dose preoperative regimen and extended dose regimen using a fluoroquinolone (levofloxacin) and amoxicillin/clavulanic acid on oral health-related QoL (OHRQoL) in otherwise healthy patients.


   Materials and Methods Top


This is an observational study conducted in the Department of Oral and Maxillofacial Surgery, Obafemi Awolowo University Teaching Hospitals Complex, Ile-Ife, Osun State, Nigeria between May 2011 and February 2012. A total of 135 healthy patients, 18–35 years old, volunteered with a written document to partake in the study. The criterion for including a patient in the study was an otherwise healthy subject that presented in the Oral and Maxillofacial Surgery Clinic for the surgical extraction of an impacted lower third molar tooth under local anesthesia. The study was conducted in accordance with good clinical practice and declaration of Helsinki as amended in Somerset West, Republic of South Africa, in 1996. The protocol was approved by the hospital ethics committee, and written, dated, informed consent was obtained from all patients before study entry. Exclusion criteria included subjects with history suggestive of underlying systemic diseases, e.g., diabetes mellitus, congestive cardiac failures, chronic nephritis, chronic liver disease, systemic malignancy, sickle cell disease, presence of acute pericoronal infection, subjects that are immune-compromised, subjects that require antibiotic prophylaxis for endocarditis, subjects with history of allergy to Penicillin and fluoroquinolone, subjects with dyspeptic symptoms or who are being treated for peptic or duodenal ulcer disease, pregnant subjects and breastfeeding mothers.

Study design

One hundred and thirty-five opaque brown and sequentially numbered envelops were used for the concealment of allocation to study groups. The three medications were designated Groups A, B, and C by an independent observer without the knowledge of the investigator. Each medication was labeled with a medication code number according to the allocation sequence that was generated online before the commencement of the study.[14] The three groups of envelopes were arranged according to the allocation sequence that was generated online and kept in the custody of an independent observer (registrar) who also dispensed the drugs to the subjects.

Eligible patients were divided into three groups of 45 patients each to receive one of the following three regimens.

  1. Group A (extended amoxicillin/clavulanic acid [GlaxoSmithKline Beecham England]), 875 mg/125 mg in a single dose 1 h before surgery and after that 500/125 mg amoxicillin/clavulanic acid (GlaxoSmithKline Beecham England) 12 hourly for 5 days
  2. Group B (Prophylactic Amoxicillin/clavulanic acid [GlaxoSmithKline Beecham England]), 875 mg/125 mg in a single dose 1 h before surgery
  3. Group C (prophylactic levofloxacin (ATOZ Pharmaceuticals Pvt Ltd., India): 1000 mg levofloxacin in a single dose 1 h before surgery.


The subjects QoL was assessed preoperatively using the 16 item United Kingdom OHRQoL measure (UK-OHRQoL).[15]

All patients were placed on the same analgesic (tabs ibuprofen 400 mg 8 hourly for 3 days). Patients were instructed not to take any other medication except the ones provided. All surgery was performed by the same surgeon using a standardized procedure under local anesthesia (2% lignocaine with 1:100,000 adrenaline).

Evaluation criteria

A review appointment was scheduled for postoperative days (PODs) 1, 3, 5, 7, and 14. On each of these days subjects were asked to complete the questionnaire (UK-O HRQoL).[15] Each item was scored: Very bad effect-score – 1, Bad effect-score – 2, No effect-score – 3, Good effect-score – 4, Very good effect-score – 5. Total scores range from 16 to 80. A lower score indicates poorer QoL. Domain scores were presented in the result.

Statistical analysis

Data analysis was carried out using Stata 10 (Statacorp College Station, Texas, USA). Descriptive statistics was carried out for sociodemographic variables. For descriptive variables that are categorical, simple frequency, and percentages were determined. Statistical analysis was performed using intention-to-treat analysis.[16] The psychometric properties of the UK-OHRQoL instrument were evaluated using internal reliability (Cronbachs' α). The effect of the intervention was determined using analysis of variance (ANOVA). Statistical significance was inferred at P < 0.05.


   Results Top


Cronbach's α were calculated for all the domains of the UK-OHRQoL ix2nstrument, and high values were obtained. For the symptom level domain, it was 0.89, for the body function level domain it was 0.81, for the personality level domain, it was 0.82, and for the social function level domain, it was 0.81.

The number of patients assessed at each study visit is shown in [Table 1]. The patients' age and the sex distributions are listed in [Table 2] whereas the preoperative clinical status is shown in [Table 3]. [Table 4] shows the distribution of mean QoL score according to domains from POD through the postoperative review periods. There was statistically significant difference in the symptom level domain on POD 1 (P = 0.016; ANOVA).
Table 1: Patients assessed at each visit

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Table 2: Sex distribution by mean age of patients in the groups

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Table 3: Distribution of preoperative clinical status among patient groups

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Table 4: Distribution of mean quality of life score domains in patient groups at pre- - and post-operative days

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[Table 5] shows the distribution of mean QoL scores in patients groups at preoperative and PODs. The mean QoL was worst among the groups on POD 1, but this gradually returned to the preoperative level by day 3. On POD 14, Qol was better as compared to preoperative value. Subjects in Group C had the least mean QoL on POD 1 (41.1 ± 4.5) whereas those in Group A had the least mean QoL (44.1 ± 4.6) on the POD 3. On POD 14, subjects in Group A had the best QoL (48 ± 4.6) although no statistically significant difference was observed (P = 0.77; ANOVA).
Table 5: Distribution of mean quality of life scores in patients groups at pre- - and post-operative days

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   Discussion Top


QoL has been considered a vague and ethereal concept. However, the importance of the subjective perception of the subjects on their own health status, measured with instruments (questionnaires) that require validation before use, has been increasingly recognized.[15] Clinical researchers began, gradually to include this type of study in clinical trials and the follow-up of subjects. Recovery for health-related QoL (HRQoL) measures includes subjects' perception of recovery, which in turn includes a return to a usual lifestyle and recovery of oral function.[15]

Clinical experience shows that subjects experience certain difficulties following removal of impacted third molar teeth. However, in the past, there was a lack of data recording changes in aspects that may influence the QoL, but now, QoL assessment is regarded as an essential component for assessing outcomes.[17] Although different methods have been used to assess QoL, it can be difficult to measure as it may mean different things to different people. Thus, such measures are subjective and multidimensional.[18] Other factors such as gender, analgesic use, and duration of surgery can also affect QoL after third molar surgery.[19] However, the main focus of the current study is the influence of oral antibiotics on QoL after third molar extraction. Studies on the effect of these variables on QoL are paramount, especially in sub-Saharan Africa were such studies are still scarce.

Results from this study showed that the surgical removal of impacted teeth exerted a negative influence on patient's QoL across various physical, social, and psychological aspects of life such as limitation in daily routine, ability to chew food, ability to open mouth, ability to speak, comfort, laughing and smiling and sleep. A significant deterioration was seen among the three groups on POD 1 at the symptom level (P< 0.0155) as measured by oral health QoL-UK (OHQoL-UK-16) scores [Table 4]. This domain (symptom level) which comprised comfort and breath odor showed a significant difference among the three groups with regard to comfort after third molar surgery. Similar to this study, McGrath et al.[20] showed deterioration in QoL in the immediate postoperative period following third molar surgery as measured by Oral Health Impact Profile-14 scores and OHQoL-UK-16. Furthermore, White et al.[21] reported that the median number of days required to return to daily activity and social life after third molar surgery was 3 days with recovery for chewing and return to regular diet taking 5–7 days respectively.[21] Colorado-Bonnin et al.[19] also concluded that lower third molar surgery significantly influences patient's QoL, especially during the first 3 days of the postoperative period. Observations from this study are similar to previous studies as subject recovery started by POD3 as evident by Mean QoL returning to the preoperative period after third molar removal in the three groups and by POD7 mean QoL has increased more than the preoperative period [Table 5].

Comparing the three groups, the Augmentin (GlaxoSmithKline Beecham England) extended group showed a slightly better QoL; although, there was no statistically significant difference among the three groups [Figure 1]. This finding could not be explained, however in a study comparing the efficacy of amoxicillin treatment in preventing postoperative complications in patients undergoing third molar extraction, better recovery of subjects were observed in the extended group.[22] Furthermore, in a study on the impact of intravenous antibiotics on HRQoL outcomes and clinical recovery after third molar surgery in 116 subjects, Foy et al.,[23] noticed that incidence of delayed clinical recovery was higher in the group without antibiotics (28% of 60 subjects) as compared with the group that had antibiotics (4% of 56 subjects). They concluded that administration of intravenous antibiotics before third molar surgery might improve clinical recovery in healthy adult patients.
Figure 1: Plot showing trend in quality of life over time

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The findings in this study could not be compared to any local study as none of such comparative study on QoL after third molar surgery was found in Nigeria and sub-Saharan Africa. This study which observed that QoL was severely compromised, especially in the first three PODs after mandibular third molar surgery could serve as baseline data from this part of the world. However, further studies from other centers are needed to validate these results.


   Conclusion Top


There was a significant deterioration in QoL in the immediate postoperative period particularly POD 1 and 3 following third molar surgery, which slowly returned to preoperative level by the 7th day. QoL was also observed to be slightly better in the amoxicillin/clavulanic extended group than the single bolus levofloxacin and amoxicillin/clavulanic groups; although, this was not statistically significant and would still need further research.

Patients undergoing mandibular third molar extraction should be adequately informed of the possible sequelae of the procedure on their QoL, especially in the immediate postoperative period to know what to expect and how to cope with such when they arise.

The limitation of this study is that placebo-controlled may have aided comparison of the effects of the antibiotics on the QoL after third molar extraction; however, this was not ethically possible as supported by the 2013 Cochrane review of antibiotic prophylaxis after the third molar extraction in the diseased environment.

Acknowledgments

The authors are grateful to the residents, house officers and dental surgery assisstants for the logistic support during the period of the study.

Financial support and sponsorship

The authors are grateful to the management of Obafemi Awolowo University Teaching Hospital Complex for part sponsoring the study.

Conflicts of interest

There are no conflicts of interest.

 
   References Top

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    Figures

  [Figure 1]
 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5]


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