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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03130933
Other study ID # SCHOOL OF DENTAL MEDICINE
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received April 17, 2017
Last updated June 14, 2017
Start date April 2010
Est. completion date November 2016

Study information

Verified date June 2017
Source University of Zagreb
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Objectives: The objective of the study was to evaluate the effectiveness of a prophylactic single preoperative dose of amoxicillin in decreasing complications after lower third molar surgery.

Materials and methods: The sample consisted of 400 patients randomly divided in two groups consisting of 200 patients per each group. The patients underwent third molar surgery at the Department of Oral Surgery, Clinical Hospital Dubrava, Croatia, in the period between April 2010. and November 2016. Unlike the patients from the second group, the first group of patients had never been diagnosed inflammation prior the surgical procedure. The main tested groups were further divided in two subgroups (control and tested): the tested subgroup (100 patients) received a prophylactic single dose of 2 g amoxicillin an hour prior the procedure, while the second control subgroup (100 patients) received a placebo. Complications, including swelling, alveolar osteitis (AO), infection at the surgical site (SSI), limited mouth opening, pain, bleeding, and increased body temperature, were evaluated postoperatively. Evaluation was done on the first postoperative day and 7 days after surgery.


Description:

Study design and sample description This prospective study was performed at the Department of Oral Surgery of Clinical Hospital Dubrava, Zagreb, Croatia, in the period from April 2010. through November 2016. All patients voluntarily agreed and written consent to participate in the study was obtained from each participant. The study was approved by Ethics Committee of the School of Dental Medicine, Zagreb, Croatia (81-2009). The identity of the subjects was protected in all phases of the study.

The exclusion criteria in this study were systematic diseases, with developing local infections, current smokers, pregnant women, lactating females, patients using oral contraceptive drugs and those under any antibiotic coverage.

The sample consisted of systematically healthy subjects between 18 to 40 years (both gender) and having semi-impacted lower third molars indicated for surgical removal randomly divided into two main groups of patients. Unlike the patients from the second group, the first group of patients had never been diagnosed inflammation prior the surgical procedure. The main tested groups were further divided in two subgroups (control and tested): the tested subgroup (100 patients) received a prophylactic single dose of 2 g amoxicillin an hour prior the procedure, while the second control subgroup (100 patients) received a placebo. The selection of third molars for control and study subgroup was made according to Pederson difficulty index (9). According to this index (Table 1), the patients are classified into 3 groups: easy, moderate and difficult. The patients from this study who were classified into a difficult group were excluded from the study due to a longer and complicated surgical procedure with an expected prolonged recovery period and possible postoperative complications.

The patients were recalled for follow-up on post-operative days one and seven. In all tested groups data had been obtained by using identical questionnaire. The following symptoms were assessed: pain, swelling, wound healing (AO, SSI), maximum inter-incisal opening of mouth, increased body temperature and hemorrhage. A postoperative follow-up was done always by the single experienced therapist. Patients evaluated their postoperative pain with grades from 0-10 using according to visual analogue scale (VAS) where the end points were marked as "no pain" (0) and "unbearable pain" (10). Surgeon evaluated the type of post-extraction alveolus healing as following normal healing, acute inflammation followed by infected alveolus and dry socket. The surgeon who assessed wound swelling did not know to which group the patient was allocated. The method of assessing the swelling was described in our previous study (10). The post-operative swelling was assessed on postoperative days 1 and 7, using four-point scale as 0=no swelling, 1=mild swelling, 2=moderate swelling, 3=severe swelling.

The maximum inter-incisal opening of the mouth was calculated from the mesioincisal angle of the ipsilateral mandibular central incisor to the mesioincisal angle of the ipsilateral mandibular central incisor using digital calliper (Caliper-Digital; Salvin Dental Specialties, Inc, Charlotte, NC).

Increased body temperature was measured by patient at home during postoperative period of seven days. Body temperature within 36.0ºC and 37.5ºC was evaluated as normal. The body temperature under 37.5 ºC was evaluated as increased. All temperatures were measured at the same time of the day, between 9:00 and 11:00 a.m.

Hemorrhage was observed by patient during next seven days after the surgical procedure. It was classified as absent or present through following days. Present hemorrhage was classified as light or intense.

The outcome variable was the presence or absence of an inflammatory complication after third molar surgery (SSI or AO). A diagnosis of SSI was identified by purulent discharge from the surgical site at any point postoperatively, fever, lymphadenopathy, or pain and edema warranting surgical intervention and/or systematic antibiotics. Alveolar osteitis was diagnosed in cases of an empty alveolar socket, increasing pain lasting more than 2 days after surgery, and exposed alveolar bone tissue.


Recruitment information / eligibility

Status Completed
Enrollment 400
Est. completion date November 2016
Est. primary completion date November 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

- systematically healthy subjects between 18 to 40 years (both gender) and having semi-impacted lower third molars indicated for surgical removal

Exclusion Criteria:

- The exclusion criteria in this study were systematic diseases, with developing local infections, current smokers, pregnant women, lactating females, patients using oral contraceptive drugs and those under any antibiotic coverage.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Lower third molar surgery
All surgical procedures were performed under local anaesthesia (alveolar nerve block) with 2% lidocaine chloride. The full-thickness mucoperiosteal flap was raised using buccal approach, adequate osteotomy was done using micromotor handpiece and bur, and third molar removal was finished using elevating instruments in the appropriate direction. Removal of bone dust, granulation tissue and broken tooth fragments were done in order to wound toileting. Gentle, sterile saline irrigation was done on the end. Primary closure of the surgical area was done using 3-0 silk sutures.
Drug:
Amoxicillin 500 Mg
The tested subgroups received a prophylactic single dose of 4 x 500 Mg Amoxicillin one hour prior the lower third molar surgery.
Other:
Placebo
The control subgroups received a prophylactic single dose of placebo one hour prior the lower third molar surgery.

Locations

Country Name City State
Croatia School of dental medicine, University of Zagreb Zagreb

Sponsors (1)

Lead Sponsor Collaborator
University of Zagreb

Country where clinical trial is conducted

Croatia, 

References & Publications (33)

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Arteagoitia MI, Barbier L, Santamaría J, Santamaría G, Ramos E. Efficacy of amoxicillin and amoxicillin/clavulanic acid in the prevention of infection and dry socket after third molar extraction. A systematic review and meta-analysis. Med Oral Patol Oral — View Citation

Bahl R, Sandhu S, Singh K, Sahai N, Gupta M. Odontogenic infections: Microbiology and management. Contemp Clin Dent. 2014 Jul;5(3):307-11. doi: 10.4103/0976-237X.137921. — View Citation

Baqain ZH, Karaky AA, Sawair F, Khraisat A, Duaibis R, Rajab LD. Frequency estimates and risk factors for postoperative morbidity after third molar removal: a prospective cohort study. J Oral Maxillofac Surg. 2008 Nov;66(11):2276-83. doi: 10.1016/j.joms.2 — View Citation

Batinjan G, Zore Z, Celebic A, Papic M, Gabric Panduric D, Filipovic Zore I. Thermographic monitoring of wound healing and oral health-related quality of life in patients treated with laser (aPDT) after impacted mandibular third molar removal. Int J Oral — View Citation

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Bortoluzzi MC, Capella DL, Barbieri T, Pagliarini M, Cavalieri T, Manfro R. A single dose of amoxicillin and dexamethasone for prevention of postoperative complications in third molar surgery: a randomized, double-blind, placebo controlled clinical trial. — View Citation

Chuang SK, Perrott DH, Susarla SM, Dodson TB. Age as a risk factor for third molar surgery complications. J Oral Maxillofac Surg. 2007 Sep;65(9):1685-92. — View Citation

Chuang SK, Perrott DH, Susarla SM, Dodson TB. Risk factors for inflammatory complications following third molar surgery in adults. J Oral Maxillofac Surg. 2008 Nov;66(11):2213-8. doi: 10.1016/j.joms.2008.06.067. — View Citation

Conrad SM, Blakey GH, Shugars DA, Marciani RD, Phillips C, White RP Jr. Patients' perception of recovery after third molar surgery. J Oral Maxillofac Surg. 1999 Nov;57(11):1288-94; discussion 1295-6. — View Citation

Crincoli V, Di Comite M, Di Bisceglie MB, Petruzzi M, Fatone L, De Biase C, Tecco S, Festa F. Which route of antibiotic administration should be used for third molar surgery? A split-mouth study to compare intramuscular and oral intake. Clin Ter. 2014;165 — View Citation

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Dodson TB. Predictors of postextraction complications in HIV-positive patients. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1997 Nov;84(5):474-9. — View Citation

Esposito S, Novelli A, de Lalla F. [Antibiotic prophylaxis in surgery: news and controversies]. Infez Med. 2002 Sep;10(3):131-44. Review. Italian. — View Citation

Falconer DT, Roberts EE. Report of an audit into third molar exodontia. Br J Oral Maxillofac Surg. 1992 Jun;30(3):183-5. — View Citation

Hall G, Nord CE, Heimdahl A. Elimination of bacteraemia after dental extraction: comparison of erythromycin and clindamycin for prophylaxis of infective endocarditis. J Antimicrob Chemother. 1996 Apr;37(4):783-95. — View Citation

Halpern LR, Dodson TB. Does prophylactic administration of systemic antibiotics prevent postoperative inflammatory complications after third molar surgery? J Oral Maxillofac Surg. 2007 Feb;65(2):177-85. — View Citation

Hawkey PM, Patel BC, Trees AJ. UK antimicrobial resistance strategy must be set in a wider context. BMJ. 2013 May 15;346:f2999. doi: 10.1136/bmj.f2999. — View Citation

Isiordia-Espinoza MA, Aragon-Martinez OH, Martínez-Morales JF, Zapata-Morales JR. Risk of wound infection and safety profile of amoxicillin in healthy patients which required third molar surgery: a systematic review and meta-analysis. Br J Oral Maxillofac — View Citation

Lee JY, Do HS, Lim JH, Jang HS, Rim JS, Kwon JJ, Lee ES. Correlation of antibiotic prophylaxis and difficulty of extraction with postoperative inflammatory complications in the lower third molar surgery. Br J Oral Maxillofac Surg. 2014 Jan;52(1):54-7. doi — View Citation

Lockhart PB, Brennan MT, Kent ML, Norton HJ, Weinrib DA. Impact of amoxicillin prophylaxis on the incidence, nature, and duration of bacteremia in children after intubation and dental procedures. Circulation. 2004 Jun 15;109(23):2878-84. Epub 2004 Jun 1. — View Citation

Lodi G, Figini L, Sardella A, Carrassi A, Del Fabbro M, Furness S. Antibiotics to prevent complications following tooth extractions. Cochrane Database Syst Rev. 2012 Nov 14;11:CD003811. doi: 10.1002/14651858.CD003811.pub2. Review. — View Citation

López-Cedrún JL, Pijoan JI, Fernández S, Santamaria J, Hernandez G. Efficacy of amoxicillin treatment in preventing postoperative complications in patients undergoing third molar surgery: a prospective, randomized, double-blind controlled study. J Oral Ma — View Citation

Marcussen KB, Laulund AS, Jørgensen HL, Pinholt EM. A Systematic Review on Effect of Single-Dose Preoperative Antibiotics at Surgical Osteotomy Extraction of Lower Third Molars. J Oral Maxillofac Surg. 2016 Apr;74(4):693-703. doi: 10.1016/j.joms.2015.11.0 — View Citation

Monaco G, Tavernese L, Agostini R, Marchetti C. Evaluation of antibiotic prophylaxis in reducing postoperative infection after mandibular third molar extraction in young patients. J Oral Maxillofac Surg. 2009 Jul;67(7):1467-72. doi: 10.1016/j.joms.2008.12 — View Citation

Ong CK, Seymour RA. Pathogenesis of postoperative oral surgical pain. Anesth Prog. 2003 Winter;50(1):5-17. Review. — View Citation

Pasupathy S, Alexander M. Antibiotic prophylaxis in third molar surgery. J Craniofac Surg. 2011 Mar;22(2):551-3. doi: 10.1097/SCS.0b013e31820745c7. — View Citation

Phillips C, Gelesko S, Proffit WR, White RP Jr. Recovery after third-molar surgery: the effects of age and sex. Am J Orthod Dentofacial Orthop. 2010 Dec;138(6):700.e1-8; discussion 700-1. doi: 10.1016/j.ajodo.2010.06.013. — View Citation

Phillips C, White RP Jr, Shugars DA, Zhou X. Risk factors associated with prolonged recovery and delayed healing after third molar surgery. J Oral Maxillofac Surg. 2003 Dec;61(12):1436-48. — View Citation

Ren YF, Malmstrom HS. Effectiveness of antibiotic prophylaxis in third molar surgery: a meta-analysis of randomized controlled clinical trials. J Oral Maxillofac Surg. 2007 Oct;65(10):1909-21. — View Citation

Seymour RA, Walton JG. Pain control after third molar surgery. Int J Oral Surg. 1984 Dec;13(6):457-85. Review. — View Citation

Waite PD, Cherala S. Surgical outcomes for suture-less surgery in 366 impacted third molar patients. J Oral Maxillofac Surg. 2006 Apr;64(4):669-73. — View Citation

Yoshii T, Hamamoto Y, Muraoka S, Furudoi S, Komori T. Differences in postoperative morbidity rates, including infection and dry socket, and differences in the healing process after mandibular third molar surgery in patients receiving 1-day or 3-day prophy — View Citation

* Note: There are 33 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Pain Patients evaluated their postoperative pain with grades from 0-10 using according to visual analogue scale (VAS) where the end points were marked as "no pain" (0) and "unbearable pain"(10). 1 day and 7 days after surgery
Secondary Swelling The post-operative swelling was assessed on postoperative days 1 and 7, using four-point scale as 0=no swelling, 1=mild swelling, 2=moderate swelling, 3=severe swelling. 1 day and 7 days after surgery
Secondary Wound healing ( AO, SSI ) Surgeon evaluated the type of post-extraction alveolus healing as following normal healing, acute inflammation followed by infected alveolus and dry socket. 1 day and 7 days after surgery
Secondary Maximum inter-incisal opening of mouth The maximum inter-incisal opening of the mouth was calculated from the mesioincisal angle of the ipsilateral mandibular central incisor to the mesioincisal angle of the ipsilateral mandibular central incisor using digital calliper (Caliper-Digital; Salvin Dental Specialties, Inc, Charlotte, NC). 1 day and 7 days after surgery
Secondary Increased body temperature Increased body temperature was measured by patient at home during postoperative period of seven days. Body temperature within 36.0ºC and 37.5ºC was evaluated as normal. The body temperature under 37.5 ºC was evaluated as increased. All temperatures were measured at the same time of the day, between 9:00 and 11:00 a.m. through 7 days
Secondary Hemorrhage Hemorrhage was observed by patient during next seven days after the surgical procedure. It was classified as absent or present through following days. Present hemorrhage was classified as light or intense. through 7 days
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