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CONTROLLED CLINICAL TRIAL TO UNDERSTAND THE NEED FORANTIBIOTICS DURING ROUTINE DENTAL EXTRACTIONS1Murali R 2Satish Kumaran 3Vinay KN1Professor and Head, Department of Public Health Dentistry, Krishnadevaraya College of Dental Sciences, Bengaluru,

India.

2Reader, Department of Oral and Maxillofacial Surgery, Institute of Dental Sciences, Barielly, UP, India.

3Senior Lecturer, Department of Oral and Maxillofacial Surgery, Institute of Dental Sciences, Barielly, UP, India.

Correspondence: Murali R, Professor and Head, Department of Public Health Dentistry, Krishnadevaraya College of Dental Sciences,

Bengaluru ,India. Email: iyemurali@gmail.com

Received Nov 15, 2011; Revised Dec 8, 2011; Accepted Dec 24, 2011

ABSTRACTIntroduction: Antibiotics are the most potent tools available for health care professionals to combat the myriadinfections affecting the humans. However, improper and rampant use of antibiotics over the years had led to resistantorganisms causing antibiotic resistant diseases. Antibiotic use in dentistry is also reaching epidemic proportions andquite a few prescriptions are not warranted.Aim: The purpose of this study was to better understand the need for antibiotics during routine dental extractions. Thehypothesis at the start of the study was that antibiotics are essential for routine dental extractions.Materials and methods: A randomized control trial was designed to understand the need for prescribing antibioticspost extraction.Results: The results showed that contrary to expectations, subjects who did not take antibiotics had event free healingexperience as compared to those who were administered antibiotics.Conclusion: This study suggests that prescription of antibiotics after routine extractions are not required and thusone of the most common practices of abusing antibiotics can be avoided.Keywords: Antibiotics, extraction, bacteria, infection.

INTRODUCTION

The abuse of antibiotics among dental healthprofessionals is reaching alarming proportions and we maysoon reach a day when the most powerful tool available tocombat microbial attack may become less effective.Remedial measures have to be initiated to prevent furtherdeterioration of the problem and we should stop theindiscriminate use of antibiotics. Antibiotics have to beprescribed in those patients who are having underlyingsystemic problems like diabetes mellitus, immuno-deficiencies, etc. Antibiotics are indicated for myriadconditions among which some of the more common aredentoalveolar abcesses, pericoronitis and fascial spaceinfections secondary to a dental causes1.

It is generally observed that most dentistsprescribe antibiotics post extraction assuming that thehealing will be uneventful, patients would not complain ofpain and recall visits could be minimized. However, recentstudies show that antibiotics are not recommended forroutine extractions1,2,3. The common practice of prescribingantibiotics post extraction has minimal effect as bacteremia

has already occurred as a result of extraction and thedefense mechanism can cope with the healing process. Fordifferent reasons, most dentists prescribe antibiotics postextraction and this has become such a common feature thatthe patients themselves request a prescription.

MATERIALS AND METHODS

A randomized, controlled trial was designed to determine ifantibiotics were necessary post extraction to aid in healingprocess with the hypothesis that antibiotics are requiredfor routine dental extractions. Patients who needed routineextractions only were included based on inclusion andexclusion criteria. The study group consisted of individualswho were prescribed antibiotics post extraction (amoxicillin500mg, TID for 3 days) while the participants in the controlgroup were not prescribed antibiotics post extraction. Thescientific proven regimen is amoxicillin 500mg, TID for 5-7days. The standard protocol used in the department of oralsurgery of the college, was amoxicillin 500mg, eight hourlyfor a minimum of three days4,5,6. The study was designed tofollow the protocol being practiced in the department tomimic the real life situation. It is important to maintain

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internal validity of the study rather than alter the protocolspecifically for the study. The final year students and internswere routinely allotted patients on a rotation basis and theprocedure was carried out under supervision by the facultymembers. The purpose of the study was to evaluate whetherthere was any difference in the healing process postextraction among the two groups. In order to promote patientcompliance and eliminate bias, both the groups wereadministered an across the counter multivitamin (Vitamin Bcomplex) table. The usual time taken for extraction was about20 minutes and there were no reported complications.

In order to evaluate the healing process, pain anddiscomfort post extraction among the two groups, it wasimperative that the patient returns for evaluation after aweek. In an effort to improve patient compliance and tomake sure all the cases were evaluated, a single suture wasplaced after extraction and specific instructions given tothe patient to return after a week to get the suture removed.

RANDOMIZATION AND BLINDING

Randomization was done by allotting cases andcontrols on a lottery basis with odd numbers favoringantibiotic administration and for even numbers, no antibioticwas administered. The cases and controls were recalledafter one week for evaluation and to determine the healingprocess. The participants, the primary investigator and theevaluator were blinded to which group they belonged. Theevaluation was done based on standard criteria of oralexamination and checking for classical symptoms ofinfection and the healing process recorded for both thegroups. We were looking for no evidence of post extractionswelling, edema, pain and any localized pus discharge fromthe extraction site.

SAMPLE SIZE

A total of one hundred subjects were includedequally dividing them between the two groups and adecision to keep the sample size at one hundred was madeto eliminate bias and improve the validity of the study.

Inclusion Criteria:

1. Healthy individuals who visit the department oforal and maxillofacial surgery as outpatients forroutine extractions.

2. Males and females between the ages of 15 and 60years. (Most patients in the lower age group hadvery few indications for extractions the emphasisbeing on preservation as also they required a muchlower dose as compared to adults(Young’s

Formula).The patients in the age groups over 60were more likely to be medically compromised andfirm teeth were a rarity in this age group.)

3. Patients with teeth that could not be salvaged orthose who preferred extraction only.

Exclusion Criteria:

1. Chronic oral infections.

2. Immune compromised patients.

3. Patients on specific drugs.

4. Tobacco users in any form.

5. Chronic alcoholics

6. Pregnant and lactating mothers.

7. Patients receiving chemotherapy or radiationtherapy.

8. Patients already on antibiotics before seeking careat our hospital.

9. Patients needing total extraction or with severeperiodontitis.

10. Patients suffering from trauma or otherpathologies.

STATISTICAL ANALYSIS

The data were reviewed for completeness and todevelop a coding scheme. Then the data was entered onMicrosoft Excel after assigning specific codes for all thevariables. The data was analyzed using SPSS Version 13statistical package. Descriptive analyses includingpercentages, averages and measures of central tendencywere used.

RESULTS

Of the 100 subjects enrolled, 99 patients reportedback for suture removal and thus evaluation was possible(fig-1). Fifteen subjects had pain and possible infectionpost extraction.

The interesting feature, contrary to expectations,was that, of these fifteen subjects, twelve patientsbelonged to the group that took antibiotics and only threepatients who did not take antibiotics developed pain andlocalized infection (purulent drainage or dry socket).

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Looking at the sex distribution of the fifteenpatients who developed pain and possible infection, sixwere females and nine males. Further, four female patientsand eight male patients who were on antibiotic coverdeveloped pain and infection (there was calor, rubor, dolorand swelling) (fig-2a, b). Comparing the age of the patientswho developed inflammation, there was no particular trend.A teenager who underwent extraction of premolars fororthodontic treatment and an elderly patient with chronicgeneralized periodontitis developed infection / dry socket.However, almost 50% of patients who developedinflammation were diagnosed to have chronic irreversiblepulpitis, followed by 25% with chronic generalizedperiodontitis (fig-3). Looking at teeth distribution,mandibular extractions (73%) had more predilection forinflammation compared to the maxillary teeth. Mandibularmolar extraction followed by mandibular premolars seemedto contribute most for the inflammation.

DISCUSSION

Our study clearly shows that for routineextractions, the body’s defence mechanism is able to takecare of the healing process without having to administerantibiotics. Antibiotics are often employed as “drugs offear”7, 8 used to “cover” for errors of omission or commissionand thereby “prevent” claims of negligence. Approximatelyone-half of all antibiotics employed in hospitals are inpatients without signs or symptoms of infection, and inmany cases are used to prevent infections or to ensure that“all was done” to prevent later criticism9.

The use of antibiotics to prevent post-treatmentinfections by giving the drugs after any dental procedure(loading dose, drug in the system before surgery begins,only against a single pathogen, only as long as bacteremiapersists, proper risk-cost/benefit ratio) completely violatesall the principles of antibiotic prophylaxis10. Antibioticprophylaxis for the prevention of surgical infections is onlyeffective if the drug is in the system before the procedurebegins and then only in clean/clean or clean/contaminatedsurgery where the drug is discontinued shortly after thesurgery is completed11. The mouth is one of the most heavilycontaminated areas of the body and may not qualify underthis scenario. The pharmacokinetics of antibiotics ensuresthat an antibiotic begun sometime after the dental procedureand without a loading dose may achieve significant bloodlevels six to twelve hours after the procedure or sometimethe next day when the issue of whether an infection occurshas already been decided (in the vast majority of casesagainst a postoperative infection).8,12,13

Although no clinical trials have demonstrated theefficacy of antibiotics in managing acute apical abscessesthat spread into fascial spaces, their use is reasonable. 14-18

Controlled Clinical Trial To Understand The Need For Antibiotics During Routine Dental Extractions

Fig: 1— Proportion of Females and Males in the study

Fig: 2a—Distribution of subjects who developedinfection with administration of antibiotics.

Fig: 2b—Distribution of subjects who developedinfection without antibiotic administration.

Fig: 3—Distribution of patients who developed infectionpost antibiotic administration (ORTHO-Orthodontictreatment, IM-Infected Molar, GP-Grossly Destructed tooth,CIP-Chronic Infective Pulpitis, CGP-Chronic GeneralizedPeriodontitis, CAP-Chronic Apical Periodontitis, AIP-AcuteInfective Pulpitis, AAP-Acute Apicial Periodontitis).

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7. I. R. Blum: Contemporary views on dry socket (alveolar osteitis): a clinicalappraisal of standardization, aetiopathogenesis and management: a critical review.Int. J. Oral Maxillofac. Surg. 2002; 31: 309–317.

8. Thomas J. Pallasch, DDS, MS.Global Antibiotic Resistance and Its Impact onthe Dental Community, J Calif Dent Assoc. 2000 Mar;28(3):215-33.

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The choice of antibiotic is empirical because no definitiveinformation on the causative pathogenic microorganismsis available. However, it is known that oral infections areusually of mixed bacteria with a predominance of obligateanaerobes19-22. It has been theorized that this diffuseinfection is mediated by streptococci, which elicit factorsthat facilitate the rapid spread of bacteria and the infectionthrough the tissues.23 The antibiotic of choice is penicillin,administered orally and with aggressive dosages24.

Contrary to the common expectation that patientson antibiotics will have event free healing, this studyshowed that maximum patients with dry sockets were onantibiotic cover (80%). However, no attempt was made tovalidate whether the intervention group completed thecourse of antibiotics. The results are an eye opener forgeneral dentists to shun the rampant use of antibiotics forroutine procedures and be selective in prescribing basedon need. Nature can help heal in most cases without havingto resort to the use of antibiotics.

There could be some inherent flaws in the studywhich could have contributed to the results. There was nocheck/ verification done on whether the patients who wereprescribed antibiotics completed the course or not. Strictnorms were followed and sterilization and asepsis wasmaintained for all patients. However, the technique ofextraction could have varied among the patients.

CONCLUSION

This study suggests that prescription of antibioticsafter routine extractions are not required and thus one ofthe most common practices of abusing antibiotics can beavoided. However, antibiotics are one of the most importanttools in preventing morbidity and mortality and extremecare and discretion should be used while prescribing thesedrugs.