Complications After Lower Third Molar Surgery

June 14, 2017 updated by: Ana Kotarac Knežević, University of Zagreb

Does a Single Dose of Systemic Antibiotics Prevent Postoperative Inflammatory Complications After Lower Third Molar Surgery? A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

400

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
      • Zagreb, Croatia, 10000
        • School of Dental Medicine, University of Zagreb

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: The first tested subgroup
The tested subgroup from the main group without prior inflammation received a prophylactic single dose of 4 x Amoxicillin 500 Mg one hour prior the lower third molar surgery.
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 Names:
  • prophylaxis
PLACEBO_COMPARATOR: The first control subgroup
The control subgroup from the main group without prior inflammation received a placebo one hour prior the lower third molar surgery .
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.

Other: Placebo
The control subgroups received a prophylactic single dose of placebo one hour prior the lower third molar surgery.
ACTIVE_COMPARATOR: The second tested subgroup
The tested subgroup from the main group with prior inflammation received a prophylactic single dose of 4 x Amoxicillin 500 Mg one hour prior the lower third molar surgery .
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 Names:
  • prophylaxis
PLACEBO_COMPARATOR: The second control subgroup
The control subgroup from the main group with prior inflammation received a placebo one hour prior the lower third molar surgery .
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.

Other: Placebo
The control subgroups received a prophylactic single dose of placebo one hour prior the lower third molar surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain
Time Frame: 1 day and 7 days after surgery
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Swelling
Time Frame: 1 day and 7 days after surgery
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
Wound healing ( AO, SSI )
Time Frame: 1 day and 7 days after surgery
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
Maximum inter-incisal opening of mouth
Time Frame: 1 day and 7 days after surgery
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
Increased body temperature
Time Frame: through 7 days
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
Hemorrhage
Time Frame: through 7 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zagreb

Investigators

  • Study Chair: Marko Granić, DMD,PhD, Second author
  • Study Chair: Tihomir Kuna, DMD, PhD, Third author
  • Study Chair: Dinko Knežević, DMD, fourth author
  • Study Chair: Nino Grgić, DMD, fifth author

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2010

Primary Completion (ACTUAL)

November 1, 2016

Study Completion (ACTUAL)

November 1, 2016

Study Registration Dates

First Submitted

April 17, 2017

First Submitted That Met QC Criteria

April 23, 2017

First Posted (ACTUAL)

April 27, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 16, 2017

Last Update Submitted That Met QC Criteria

June 14, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • School of Dental Medicine (Other Identifier: University of Zagreb)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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