Complications After Lower Third Molar Surgery

NCT03130933 | Completed Phase 1 DMC

• 1 other identifier: SCHOOL OF DENTAL MEDICINE
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Complications; Third Molar

Keywords

third molar; oral surgical procedures; antibiotic prophylaxis; placebo effect

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Swelling

  1 day and 7 days after surgery

• Wound healing ( AO, SSI )

  1 day and 7 days after surgery

• Maximum inter-incisal opening of mouth

  1 day and 7 days after surgery

• Increased body temperature

  through 7 days

• Hemorrhage

  through 7 days

Study Arms (4)

The first tested subgroup

ACTIVE COMPARATOR

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; Drug: Amoxicillin 500 Mg

The first control subgroup

PLACEBO COMPARATOR

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; Other: Placebo

The second tested subgroup

ACTIVE COMPARATOR

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; Drug: Amoxicillin 500 Mg

The second control subgroup

PLACEBO COMPARATOR

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; Other: Placebo

Interventions

Lower third molar surgery PROCEDURE

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 first control subgroup; The first tested subgroup; The second control subgroup; The second tested subgroup

Amoxicillin 500 Mg DRUG

The tested subgroups received a prophylactic single dose of 4 x 500 Mg Amoxicillin one hour prior the lower third molar surgery.

Also known as: prophylaxis

The first tested subgroup; The second tested subgroup

Placebo OTHER

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

The first control subgroup; The second control subgroup

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

Sponsors & Collaborators

• University of Zagreb: lead

Study Sites (1)

School of dental medicine, University of Zagreb

Zagreb, 10000, Croatia

Location

Related Publications (33)

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Related Links

• Conaty S, Hoang H, Kirshen D, Kwong C, Schroeder E, Stromme A: Pre and post-operative antibiotic prophylaxis in the prevention of complications following third molars surgery

MeSH Terms

Conditions

Postoperative Complications

Interventions

Amoxicillin

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: There was 400 participiants, patients and the same oral surgeon
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: A RANDOMIZED CONTROLLED TRIAL

Study Record Dates

• First Submitted: April 17, 2017
• First Posted: April 27, 2017
• Study Start: April 1, 2010
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: June 16, 2017

Record last verified: 2017-06

Locations

CR (1)