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Year : 2016  |  Volume : 12  |  Issue : 2  |  Page : 565-570

Antibiotic protocol for the prevention of osteoradionecrosis following dental extractions in irradiated head and neck cancer patients: A 10 years prospective study

1 Department of Oral and Maxillofacial Surgery, College of Dentistry, King Saud University, Riyadh, Kingdom of Saudi Arabia
2 King Faisal Specialist Hospital and Research Center, Riyadh, Kingdom of Saudi Arabia

Date of Web Publication25-Jul-2016

Correspondence Address:
Saleh A Al-Bazie
Department of Oral and Maxillofacial Surgery, College of Dentistry, King Saud University, P.O. Box 60169, Riyadh 11545
Kingdom of Saudi Arabia
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/0973-1482.159090

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 > Abstract 

Aims of Study: The aim of the study was to establish the long term efficacy of a perioperative antibiotic protocol combined with antibacterial mouthwashes in preventing osteoradionecrosis (ORN).
Materials and Methods: Irradiated head and neck cancer patients reporting for dental extractions were prospectively enrolled to the study between January 2002 and December 2009. Selection criteria for the patients included the presence of nonrestorable tooth/teeth in the field of radiation, latency period of 6 months since completion of radiotherapy, radiation dosages >60 Gy, and availability for follow-up. Starting from 10 days preextraction, the patients were prescribed 8th hourly oral amoxicillin 500 mg along with 12th hourly mouthwashes using 10 ml of undiluted chlorhexidine gluconate 0.2% solution. The same prescription was continued for 7 days postextraction. All patients were followed-up at regular intervals until December 2013.
Results: A total of 89 patients (55 male and 34 female) underwent extractions of teeth which were present in the radiation field. Mean age of the patients was 41.8 years (range 36–54 years) and extractions were done between 12 and 33 months (mean – 15 months) postradiation therapy. Altogether, 232 teeth were extracted (maxilla – 78/mandible – 154) at an average of 2.6 teeth per patients. After a mean follow-up period of 63 months (range 48–123 months) there were no reported cases of ORN.
Conclusion: Based on the results of this study, perioperative oral antibiotics in combination with antibacterial mouthwashes are effective in preventing ORN following dental extractions in irradiated patients.

Keywords: Antibiotics, dental extraction, head and neck cancer, oral cancer, radiation therapy

How to cite this article:
Al-Bazie SA, Bahatheq M, Al-Ghazi M, Al-Rajhi N, Ramalingam S. Antibiotic protocol for the prevention of osteoradionecrosis following dental extractions in irradiated head and neck cancer patients: A 10 years prospective study. J Can Res Ther 2016;12:565-70

How to cite this URL:
Al-Bazie SA, Bahatheq M, Al-Ghazi M, Al-Rajhi N, Ramalingam S. Antibiotic protocol for the prevention of osteoradionecrosis following dental extractions in irradiated head and neck cancer patients: A 10 years prospective study. J Can Res Ther [serial online] 2016 [cited 2022 Sep 28];12:565-70. Available from: https://www.cancerjournal.net/text.asp?2016/12/2/565/159090

 > Introduction Top

Head and neck cancer generally requires aggressive multimodality treatment using a combination of surgery and radiotherapy with or without adjuvant chemotherapy. More than two-thirds of the patients with head and neck cancer present with advanced stage disease which requires concomitant surgery and radiotherapy.[1],[2],[3] Furthermore, radiotherapy has also been used as a single primary therapy for early stage cancer and for palliative treatment of highly advanced stage cancer.[4] A combination of high cellular turnover, diverse microflora and susceptibility to functional trauma, results in a greater likelihood of radiation-induced adverse effects to the oral cavity and perioral structures.[2],[3] As a result of which, most radiotherapy protocols dictate radiation dose and delivery rates which can eradicate malignant tissue and concomitantly preserve normal tissue in order to avoid debility.[2] Nevertheless, an acceptable degree of normal tissue damage is certain.

Bone is relatively radioresistant compared to other soft tissues.[1] However, radiation-induced hypoxia, hypocellularity, and hypovascularity leads to diminished reparative ability of the bone.[5] Osteoradionecrosis (ORN) is defined as an area of irradiated bone which fails to heal over a long time and results in exposed and devitalized bone in the absence of any neoplasm.[2],[5],[6],[7] ORN is a devastating outcome of radiotherapy for head and neck cancer, which is not only difficult to treat but can also lead to bony deformity. Periodontal diseases, dental caries with periapical pathosis, functional trauma from dentures, and dental extraction have been implicated in the etiology of ORN.[6],[8],[9],[10],[11] Dental extractions either before or after radiotherapy are considered as the single largest cause of ORN of the jaws.[2]

Several reports in the literature suggest that elective dental extractions done prior to radiotherapy, reduce the incidence of ORN when sufficient time interval was provided between extraction and radiation exposure.[12],[13],[14] Nevertheless, dental extractions have been done postirradiation along with several adjuvant modalities to prevent ORN. Prophylactic measures such as preoperative antibiotic therapy [15],[16] and hyperbaric oxygen [17],[18],[19],[20],[21] (HBO) have been widely used. In addition, intra-operative modifications like atraumatic extractions, minimal periosteal stripping, alveoloplasty, primary closure, limiting the number of teeth extracted in a single appointment, and administration of local anesthetic without adrenaline have been proposed to reduce the incidence of ORN.[2] HBO therapy which is known for its efficiency in promoting angiogenesis and fibroblast activity,[11] is currently not popular owing to its questionable value in preventing and treating ORN,[22],[23],[24] and its prohibitive cost. While there has been a reported preference among oral and maxillofacial surgeons to use perioperative antibiotics for dental extractions postradiotherapy,[15] there is no clear protocol to guide the same.

The aim of the present study was to establish the long term efficacy of a perioperative antibiotic protocol comprising of orally administered amoxicillin in combination with chlorhexidine mouthwash in preventing ORN in irradiated head and neck cancer patients reporting for dental extractions.

 > Materials and Methods Top

Ethical approval for the present study was obtained from the institutional ethics committee at King Faisal Specialist Hospital and Research Center, Riyadh, Kingdom of Saudi Arabia.

Patient selection criteria

Irradiated head and neck cancer patients reporting to the oral and maxillofacial surgery outpatient department at King Faisal Specialist Hospital and Research Center were prospectively enrolled to the study starting from January 2002 until December 2009. The patients enrolled included all patients reporting to the clinic with previous history of radiotherapy for head and neck cancer, and presenting with dental complaints de novo and patients referred from the dental outpatient clinic and the multidisciplinary cancer clinic. It was a routine protocol to institute preradiotherapy dental prophylaxis for patients attending for radiotherapy in the institution where the study was conducted. The patients were consecutively included into the final study group based on the following inclusion criteria:

  • History of head and neck cancer treated by radiotherapy which included the maxilla, mandible or both in the field of radiation as evidenced by radiation oncology records
  • Evidence of preradiotherapy dental prophylaxis regimen comprising extraction of all teeth with poor or hopeless prognosis, oral hygiene instructions, and oral fluoride application once in 3 months
  • Presence of nonrestorable tooth/teeth in the field of radiation and indicated for extraction in the maxilla, mandible or both
  • Radiation dosage >60 Gy
  • Latency period of at least 6 months between completion of radiation therapy and extraction
  • No previous ORN, ulcers or bone exposure at the extraction site
  • A minimum follow-up time of at least 3 months for unhealed sockets to heal completely
  • Availability of the patient for long term follow-up
  • Criteria for diagnosis of ORN were based on clinical examination of the extraction site in question
  • ORN was defined as an area of the extraction socket with exposed, dead bone which does not heal within a period of 6 months.

Antibiotic protocol

All patients included to the study were educated about the study protocol, its nature, possible merits, demerits and adverse effects. After obtaining an informed consent for dental extraction, the patients were prescribed the following medication:

  • Amoxicillin 500 mg taken orally every 8th hourly starting from 10 days before the extraction and continued for 7 days after the extraction
  • In patients allergic to beta-lactam antibiotics, clindamycin 300 mg taken orally every 8th hourly starting from 10 days before the extraction and continued for 7 days after the extraction
  • Antibacterial mouthwashes with 10 ml of undiluted chlorhexidine gluconate 0.2% solution for 1 min every 12th hourly starting from 10 days before the extraction and continued for 7 days after the extraction.

All medications were provided to the patient during the preoperative visit to the clinic and instructions regarding medication usage were provided verbally to the patient and one more adult by-stander of the patient. In addition, printed instructions for medication usage in the vernacular language were also given to the patient.

Surgical protocol

All dental extractions were done under local anesthesia using lidocaine 2% solution containing vasoconstrictor adrenaline (1: 200,000) (xylocaine 2% with adrenaline 1: 200,000). In patients contraindicated for adrenaline due to systemic conditions, local anesthesia was administered using prilocaine 3% solution containing vasoconstrictor octapressin (Citanest 3% with octapressin 0.03 I.U. per ml). All extraction procedures were done as atraumatically as possible. Following extraction the socket was gently debrided to remove loose fragments, socket walls were filed to smoothen sharp bony edges, and irrigated with sterile normal saline solution. While intra-alveolar extraction sockets were not sutured, trans-alveolar extraction sockets were sutured with interrupted sutures (4-0 Chromic Catgut sutures, Ethicon, Johnson, and Johnson) which were removed on the 5th postoperative day. Extraction of impacted wisdom teeth was done using standard incision and flap designs and after bone removal under sterile saline irrigation. Following removal of impacted teeth the sockets were closed primarily with interrupted sutures (4-0 Chromic Catgut sutures, Ethicon, Johnson, and Johnson) after debridement and smoothening of socket walls and irrigation of the socket. The sutures were removed on the 7th postoperative day.

Follow-up evaluation

All patients were asked to return for weekly follow-up visits for the 1st postoperative month, followed by monthly visits up to 6 months after which the patients were seen once every 3 months for 2 years. Patients who were free from any adverse effects even after 2 years were further asked to follow-up with the oral and maxillofacial surgery clinic once every 6 months along with their scheduled follow-up with the multidisciplinary cancer team throughout their life. Follow-up information up to and until December 2013 was included for the present study.

Statistical analysis

Data collected were tabulated and analyzed using Spreadsheet software (Microsoft Excel 2010). Descriptive analysis of numeric variables for measures of central tendency and dispersion, and categorical variables for frequencies was done. Incidence of ORN was assessed individually.

 > Results Top

A total of 2232 patients with a history of head and neck cancer reported to the oral and maxillofacial surgery clinic between January 2002 and December 2009. Out of which 1521 patients had a history of radiotherapy to the maxillofacial region as either the primary treatment modality or as an adjuvant treatment modality. Among the irradiated patients, 225 patients were either referred to or reported themselves for dental extractions. A total of 89 patients presented with nonrestorable teeth in the field of radiation exposure within the maxilla, mandible or both and qualified for the inclusion criteria. In spite of a preradiotherapy dental prophylaxis protocol in place, only nine patients (10.1%) out of the 89 could not adhere to the postradiotherapy oral fluoridation appointments, due to personal circumstances. The mean age of the patients was 41.8 years (range 36–54 years) and the male to female ratio was 3:2 approximately (55 males and 34 females). Majority of the patients in the present study had a primary tumor in the nasopharynx (39.2%) [Table 1].
Table 1: Demographic characteristics of study population (n=89)

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The mean radiation dose was 65.4 Gy (range 60–72 Gy). A total of 232 teeth were extracted from the field of radiation exposure, out of which 78 were maxillary teeth and the remaining 154 were mandibular teeth. The anatomic locations of all the extracted teeth are presented in [Table 2]. On average, 2.6 teeth were extracted from each patient, with a maximum of 6 teeth in a single patient. After a mean follow-up period of 63 months (range 48–123 months), there were no reported cases of ORN. However, three patients (3.4%) reported with delayed healing, which was managed by conservative methods and healed subsequently before 3 months. The mean time period between completion of radiotherapy and dental extraction was 15 months (12–33 months).
Table 2: Sites of dental extraction

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 > Discussion Top

Dental extractions are considered as a major causative factor of ORN, as a result of which, the relationship between exodontias, radiotherapy, and irradiated bone must be considered important.[4] There have been paradigm changes in our understanding of the pathogenesis of ORN. Earliest reports by Watson and Scarborough, based on clinical findings, suggested that ORN arose as a result of a combination of three factors namely, exposure to radiation, local tissue injury, and infection.[25] This was supported by Meyer, who proposed a radiation, trauma and infection theory for pathogenesis of ORN.[26] Marx suggested a major shift in the understanding of ORN pathophysiology when he suggested his theory of hypoxic-hypocellular-hypovascular tissue as the cause for ORN.[5],[27] More recently in 2004, a radiation-induced fibroatrophic theory has also been proposed based on the cellular and molecular mechanisms involved in the pathogenesis of ORN.[10] According to this theory, bone and tissue necrosis in ORN is a result of dysregulation of fibroblastic activity involving radiation-induced free radical damage to the microvasculature, osteogenic cells, and fibroblasts.[27] Nevertheless, the contributing role of micro-organisms in ORN pathogenesis has not been discounted by any long term studies.

While ORN has been reported in patients who underwent dental extractions prior to radiotherapy,[4],[28],[29],[30] majority of ORN cases have been associated with postirradiation dental extractions.[4],[7],[11],[30],[31],[32],[33] Based on a single center, long term analysis, Koga et al.[4] reported a large series of dental extractions in irradiated patients. Out of 405 patients, they reported only 3 cases of ORN associated with dental extractions, of which only one case (out of 57 patients, 1.7%) was associated with postirradiation dental extraction. A total of 232 dental extractions were done on 89 patients in the present study and all procedures were performed postradiation therapy. None of our patients developed ORN during a mean follow-up period of 63 months. Similar results have been reported by Regezi et al.[30] (23 extractions in 10 patients), Makkonen et al.[13] (88 extractions in 25 patients), and Maxymiw et al.[34] (126 extractions in 72 patients). Nevertheless, the number of procedures per patient reported (2.6 per patient) and the extensive follow-up period, combined with the antibiotic protocol followed, makes our study unique from those reported previously.

Majority of teeth extracted in the present study were posterior teeth (premolars and molars), with the mandibular teeth more than the maxillary teeth. The mandible has been reported to be at greater risk for developing ORN following extractions compared to the maxilla.[2],[4],[35] All the cases of delayed healing reported in the present study were also in mandibular extraction sites. The pattern of mandibular blood supply, greater exposure to radiation and transection of the external maxillary artery during neck dissection are the reasons cited for impaired healing in the mandible and subsequently greater risk for ORN.[2] Nasopharyngeal cancer was the commonest primary tumor site in the present study. Incidentally, Lye et al.[36] have reported a series of 155 dental extractions in 40 patients following radiotherapy for nasopharyngeal cancer. Their protocol was similar to that of the present study except for the duration of antibiotic therapy and they reported a low complication rate of 1.9% risk of ORN and 5.8% risk of delayed healing. All the complications reported in their case series were also in the posterior maxilla and the posterior mandible. The nature of radiation therapy targeting nasopharyngeal cancer sites could explain the greater incidence of complications seen in posterior dental extraction sites.

Peri-extraction antibiotics in irradiated patients have been reported as auxiliary therapy for prevention of ORN.[4],[15],[34] While antibiotics are used routinely, there is no clear indication regarding the type and dosage of the antibiotics. Maxymiw et al.[34] used 2 g penicillin V 1 h before extraction, followed by 600 mg 4 times a day for 1 week in 72 patients and reported no ORN in their case series. Koga et al.[4] based on their series of 57 patients with postirradiation dental extraction, reported documented antibiotic usage in 86% and probable undocumented usage in the remaining 14% of patients and only one patient developed ORN. Lye et al.[36] prescribed 2 g penicillin V 1 h before extraction, followed by oral penicillin V and metronidazole for 1 week along with chlorhexidine mouthwashes for 155extractions and reported 3 cases of ORN and 9 cases of delayed healing. In the present study, all patients received antibiotics perioperatively (oral amoxicillin 500 mg 3 times a day) starting from 10 days before extraction and continued postoperatively for 7 days. Oral clindamycin was not used as none of the patients were reportedly sensitive or allergic to beta-lactam antibiotics. There were no reported adverse effects due to the antibiotic usage in the present study population. Only delayed healing was observed in three patients and none of the patients developed ORN. It is alluring to hypothesize that the extended preoperative antibiotics prescribed in the present study contributed to the better results compared to previously reported studies.

Data in the form of randomized controlled trials evaluating the use of antibiotics to prevent ORN are limited. Nevertheless, there is ample evidence in literature which supports usage of antibiotics to prevent and treat ORN.[2],[4],[15] Bacterial colonization of the affected tissues has been reported since early experimental models that were used to study pathophysiology of ORN.[37] The foundation for antibiotic prophylaxis prior to oral surgery in irradiated patients and antibiotic therapy for the treatment of ORN was based on Meyer's radiation-trauma-infection hypothesis.[26],[38] Several authors have reported that injury to the oral tissues provides an opening for entry of oral micro-organisms into the underlying irradiated bone which leads to infection.[10] Even the strongest proponent of HBO therapy, Marx believed that bacteria played a contaminating role in an already necrotic focus of bone.[27] However, Støre and Olsen [39] based on electron microscopic and molecular DNA-DNA hybridization studies, not only documented the presence of bacteria in ORN bone, but also suggested an important role for bacteria in the pathogenesis of ORN. This has been the strongest evidence so far, implicating bacteria in ORN.

The use of HBO therapy for the prevention of ORN is largely based on the results of Marx et al.[19] In their clinical trial comparing HBO therapy and antibiotics prior to extraction in irradiated mandibles, the incidence of ORN was 5.4% in the HBO group and 29.9% in the antibiotic group. The lack of further controlled trials in this realm has led to the anecdotal usage of HBO therapy.[10] In a more recent random, placebo-controlled, double blind study to assess the efficacy of HBO, the authors had to end the study midway owing to the negligible beneficial effect of HBO over placebo in preventing or treating ORN.[35] Moreover, except for cases involving resection and reconstruction surgeries postirradiation, there is no sound evidence for the routine use of HBO therapy.[35] In spite of its availability, HBO therapy was not used in the present study due to inadequate scientific basis, lengthy process and its prohibitive cost factor.

Nabil and Samman reported a decreasing trend in the incidence of postirradiation extraction.[2] According to them, the incidence of ORN prior to 1990 was 16%, while it reduced to 2% after that. Technical advances in radiation therapy, better oral health education and preventive dental prophylaxis regimens among irradiated patients have been cited as the possible reasons for the decrease. A strict preradiotherapy dental prophylaxis regimen was administered for all the patients in the present study except for nine patients who missed their postradiotherapy fluoridation appointments. Nevertheless, patients did develop dental problems postradiotherapy, which could be attributed to changes in their quality of life and disregard for oral health in comparison to general health.[2] In addition to strict oral hygiene compliance, preventive options like ultrasound and combinations of pentoxifylline and tocopherol have been reported to show beneficial results in irradiated patients undergoing dental extractions.[2],[10] However, long term studies proving their efficacy in preventing ORN are currently unavailable in the literature. As a result, physicians treating patients at risk of developing ORN have only limited options in the form of antibiotics and HBO therapy. Considering the cumbersome nature of preparation and administration for HBO therapy, and its inadequate scientific basis most oral surgeons prefer to use perioperative antibiotics in irradiated patients.[2],[4],[15],[36]

The absence of a suitable control group for comparison is a limitation of the present study. However, the study results indicate the efficacy of an antibiotic protocol, comprising perioperative oral antibiotics and antibacterial mouthwashes, in preventing ORN following dental extractions in irradiated head and neck cancer patients. While future long term multi center studies could provide further insight into the mechanisms by which antibiotics help prevent ORN, the importance of good oral hygiene maintenance following radiation therapy to prevent ORN needs to be stressed.

 > References Top

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  [Table 1], [Table 2]

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