Postoperative Complications Clinical Trial
Official title:
Does a Single Dose of Systemic Antibiotics Prevent Postoperative Inflammatory Complications After Lower Third Molar Surgery? A Randomized Controlled Trial
Verified date | June 2017 |
Source | University of Zagreb |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Croatia | School of dental medicine, University of Zagreb | Zagreb |
Lead Sponsor | Collaborator |
---|---|
University of Zagreb |
Croatia,
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* Note: There are 33 references in all — Click here to view all references
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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