Complications After Lower Third Molar Surgery
Condition: Postoperative Complications; Third Molar
MeSH terms: Postoperative Complications
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    

Detailed 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.
    

Intervention name(s): Lower third molar surgery; Amoxicillin 500 Mg; Placebo
Intervention type(s): Procedure; Drug; Other
Intervention description(s): 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.; The tested subgroups received a prophylactic single dose of 4 x 500 Mg Amoxicillin one hour prior the lower third molar surgery.; The control subgroups received a prophylactic single dose of placebo one hour prior the lower third molar surgery.
Other intervention name(s): prophylaxis
Intervention MeSH terms: Amoxicillin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A RANDOMIZED CONTROLLED TRIAL
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: third molar; oral surgical procedures; antibiotic prophylaxis; placebo effect