Abstract
This double-blind, randomized controlled study was done to assess the necessity of systemic antibiotics in the prevention of wound healing complications after intra-alveolar dental extraction. A consecutive recruitment method was used to allocate participants to two treatment groups. Subjects in group A (antibiotics group, n = 75) received amoxicillin and metronidazole for 5 days postoperatively, while those in group B (placebo group, n = 75) were given identical-looking placebo drugs in place of the antibiotics. Postoperative socket healing complications, pain, and compliance with postoperative instructions were assessed postoperatively. Healing was uneventful in 129 patients (86%). Twenty-one patients (14%) developed wound healing complications. Dry socket was the most common complication in the antibiotics group (six subjects), while acutely inflamed sockets was the most common in the placebo group (five subjects). Non-adherence to postoperative instructions and postoperative pain were found to be significantly associated with the development of wound healing complications. The prescription of antibiotics after routine intra-alveolar dental extraction in healthy patients may not play any significant role in preventing wound healing complications. However, non-compliance with postoperative instructions might be associated with increased wound healing complications.
Tooth extraction is the most common procedure in oral surgical practice. In an ideal situation, it entails the painless removal of the whole tooth or its root, with minimal trauma to the surrounding soft tissues. Successful tooth extractions are based on an understanding of the basic surgical principles of the procedure. In spite of this understanding, complications still arise, although their frequency is reported to have reduced following advancements in knowledge and techniques. In clinical practice, antibiotics are sometimes prescribed post-extraction to prevent these complications. This practice is, however, controversial. The prescription of antibiotics post-extraction is supported by those who believe that extraction wounds require antibiotics to heal unevenfully. Others hold a dissenting view and claim that the risk of developing infectious complications following tooth extraction is too small to warrant antibiotic use, even with surgical extractions. This latter group further argues that the defence mechanisms of the body enable the healing process to ensue without the need for antibiotics.
Guidelines for the use of antibiotics are generally available for most surgical procedures. These principles are well established and are related to the procedure being performed, the type of wound, and the health of the patient. However, they are reportedly not always followed. Statistics even show that approximately half of the total antibiotic prescriptions in many hospitals across the globe are administered with neither signs nor symptoms of an ongoing infection, and a proportion of this misuse is attributed to prescription by dental experts. In addition, the literature also reveals that antibiotics are sometimes used as ‘drugs of fear’ to cover negligence and errors committed during surgical procedures.
Justification for the use of antibiotics, especially after dental extractions, comes from the vast information in text books, dental school instructions, and even continuing education lectures. This justification, coupled with anecdotal evidence that patients tend to get better whenever antibiotic drugs are prescribed, has resulted in their continual use. The worry is that this trend, if unabated, could culminate in multiple microbial resistance, thus reducing the effectiveness of antibiotics, which to date remain the most powerful tools available in combating microbial attacks.
This double-blind, randomized controlled study aimed to determine the role of postoperative antibiotic medication in the prevention of infectious complications following routine intra-alveolar dental extractions in a hospital in Lagos, Nigeria.
Materials and methods
This study was conducted in the dental outpatient department of a general hospital in Lagos, Nigeria. All consecutive patients who met the inclusion criteria and agreed to participate were included in the study. Inclusion criteria encompassed male and female subjects, aged between 20 and 50 years, who required a routine intra-alveolar extraction. Patients with chronic oral infections, immune-compromised patients, and pregnant and lactating women were excluded from the study. Also excluded were patients receiving chemotherapy or radiation therapy, patients already on antibiotics before seeking care at the hospital, patients needing total extraction or with severe periodontitis, and patients who had any other oral pathology. Ethical clearance was obtained for the study and written informed consent was also obtained from each patient after they were assured of the confidentiality of the findings of the study.
A consecutive recruitment method was used to enrol patents in the study. After their dental extraction, eligible patients were allocated randomly to the antibiotics or placebo group by picking tallies from a box that was pre-marked A or B. The letter picked by the patient determined the treatment group the patient was assigned to. Neither the patient nor the postoperative assessor knew the treatment assigned to the group they had picked. The grouping was known only to the chief pharmacist of the hospital, through whom the drugs for the study were supplied. The antibiotics and placebo drugs were identical in appearance and were supplied by the same company (Emzor Pharmaceutical Industries Ltd, Lagos, Nigeria).
For all recruited patients, the extraction was performed with dental forceps and/or elevators by surgeons of a similar level of experience, with as little trauma as possible to the surrounding soft tissues. A preoperative oral rinse with 0.12% chlorhexidine mouthwash was done 1–2 min prior to the commencement of each procedure. The dental extractions were done after injection of lidocaine (2%) with adrenaline (1:80,000). Following the extraction, the socket was packed with gauze and the patient was asked to bite hard on it, to apply pressure to the socket wound; the socket was checked for haemostasis after about 20 min.
All patients were given the same post-extraction instructions, both verbally and in written form, as follows: (1) do not rinse vigorously, suck on straws, for 24 h; (2) do not smoke or drink alcohol for 72 h; (3) commence warm saline mouth wash/bath after 24 h, six times daily for 1 week; (4) commence the use of analgesics and antibiotics immediately after removal of the pack from the mouth, as directed.
Patients in the antibiotic group (group A) received the following drugs from the pharmacy: amoxicillin 500 mg every 8 h for 5 days, metronidazole 400 mg every 8 h for 5 days, paracetamol 1000 mg every 8 h for 3 days, and vitamin C 100 mg every 8 h for 2 weeks. Patients in the placebo group (group B) were given placebo tablets in place of amoxicillin and metronidazole for the same durations, paracetamol 1000 mg every 8 h for 3 days, and vitamin C 100 mg every 8 h for 2 weeks.
To promote patient compliance and eliminate bias, both groups were given drugs directly from the hospital pharmacy. All patients were reviewed on days 1, 3, and 7 postoperatively for the assessment of socket wounds and compliance with both the postoperative instructions and use of medications. All postoperative assessments were done by one of the investigators (IMD) to prevent inter-examiner variability.
Patients who did not show up for review and those who took any other medication during the period of assessment apart from the drugs prescribed were withdrawn from the study. Patients who developed socket healing complications were also withdrawn from the study and transferred to the oral surgery department for management of the complications; however, their data were included in the analysis. Patients were also instructed to report any case of increased persistent pain or other unusual experience.
Clinical evaluation of the extraction sockets was done based on the following criteria : (1) normal healing alveolus: a healing alveolus with decreasing pain or without pain, with evidence of gradual or complete socket closure. (2) Dry socket: persistent or increased postoperative pain in and around the extraction site, accompanied by a partially or totally disintegrated blood clot or an empty socket, with or without halitosis; the diagnosis is confirmed when extremely sensitive bare bone is encountered when passing a small curette into the extraction wound. (3) Acutely inflamed socket: painful socket with inflamed tissue, but without pus or systemic fever. (4) Acutely infected socket: painful socket with suppuration, erythema, and oedema, with or without systemic fever.
Pain was assessed using a four-point verbal rating scale (VRS) and categorized as follows: 1 = no pain (no pain experienced); 2 = mild pain (pain almost unnoticeable); 3 = moderate pain (noticeable pain, but does not disturb daily activities); 4 = severe pain (very noticeable pain that disturbs daily activities).
Patients were questioned regarding compliance with both antibiotic use and the postoperative instructions, and their responses were recorded as either ‘followed instructions’ or ‘did not follow instructions’.
Data were recorded and analyzed using SPSS version 17.0 software (SPSS Inc., Chicago, IL, USA). Percentages and mean and standard deviations of numerical variables were determined. The χ 2 test or Fisher’s exact test (as appropriate) was used to compare categorical variables, while the Student t -test was used to compare numerical variables. The confidence interval was set at 95% for all statistical tests.
Results
A total of 171 patients were enrolled in the study. Twenty-one patients – 11 in group A and 10 in group B – were lost to follow-up and were thus excluded from the analysis. This gave a response rate of 87.7%. The recruited patients ranged in age from 20 to 50 years (mean age 30.6 ± 9.3 years). The majority of the subjects (46.7%) were in the age group 20–29 years ( Table 1 ). There were 68 males and 82 females (male-to-female ratio 1:1.2).
| Variable | Group A Antibiotics n = 75 (100%) |
Group B No antibiotics n = 75 (100%) |
χ 2 | P -value |
|---|---|---|---|---|
| Age group, years | 0.113 | 0.945 | ||
| <30 | 36 (48) | 34 (45.3) | ||
| 30–39 | 26 (34.7) | 27 (36) | ||
| ≥40 | 13 (17.3) | 14 (18.7) | ||
| Mean age | 30.1 ± 9.1 | 31.8 ± 9.4 | ||
| Sex | 0.108 | 0.743 | ||
| Male | 35 (46.7) | 33 (44) | ||
| Female | 40 (53.3) | 42 (56) | ||
| Ethnic group | 1.52 | 0.461 | ||
| Yoruba | 41 (54.7) | 34 (45.3) | ||
| Igbo | 25 (33.3) | 28 (37.3) | ||
| Other | 9 (12) | 13 (17.3) | ||
| Cigarette smoker | 0.000 | 1.000 | ||
| Yes | 3 (4) | 3 (4) | ||
| No | 72 (96) | 72 (96) | ||
| Alcohol drinker | 0.074 | 0.785 | ||
| Yes | 8 (10.7) | 7 (9.3) | ||
| No | 67 (89.3) | 68 (90.7) | ||
| Tooth extracted | 1.798 | 0.407 | ||
| Anterior | 4 (5.3) | 8 (10.7) | ||
| Premolar | 15 (20) | 17 (22.7) | ||
| Molar | 56 (74.7) | 50 (66.7) | ||
| Location of extracted tooth | 0.96 | 0.327 | ||
| Maxilla | 35 (46.7) | 41 (54.7) | ||
| Mandible | 40 (53.3) | 34 (45.3) | ||
| Indication for tooth extraction | 0.07 | 0.797 | ||
| Caries | 67 (89.3) | 69 (92) | ||
| Other | 8 (10.7) | 6 (8) | ||
| Preoperative pain | 0.03 | 0.864 | ||
| Mild/moderate | 27 (36) | 26 (34.7) | ||
| Severe | 48 (64) | 49 (65.3) |
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