Postoperative ComplicationsPhase 1/2NCT03130933
Complications After Lower Third Molar Surgery
A Phase 1/2 study testing Lower third molar surgery and Amoxicillin 500 Mg in people with Postoperative Complications and Third Molar, run by University of Zagreb at 1 site in Croatia.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Postoperative Complications, Third Molar
- What is being tested?
- Lower third molar surgery and Amoxicillin 500 Mg
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteCroatia
- Study dates
- Apr 2010to Nov 2016
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- systematically healthy subjects between 18 to 40 years (both gender) and having semi-impacted lower third molars indicated for surgical removal
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Postoperative Complications, Third Molar
- Being tested
- Lower third molar surgery, Amoxicillin 500 Mg, Placebo
- Keywords
- third molar, oral surgical procedures, antibiotic prophylaxis, placebo effect
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lower third molar surgeryProcedure or 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.
Amoxicillin 500 MgDrug
Also called prophylaxis
The tested subgroups received a prophylactic single dose of 4 x 500 Mg Amoxicillin one hour prior the lower third molar surgery.
PlaceboOther
The control subgroups received a prophylactic single dose of placebo one hour prior the lower third molar surgery.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 . Receives: 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 . Receives: 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 . Receives: Procedure: Lower third molar surgery; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 day and 7 days after surgery
Secondary outcomes (5)
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.
Measured: 1 day and 7 days after surgery
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.
Measured: 1 day and 7 days after surgery
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).
Measured: 1 day and 7 days after surgery
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.
Measured: through 7 days
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.
Measured: through 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2017
- Study startApr 2010
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A RANDOMIZED CONTROLLED TRIAL
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zagreb
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Kotarac Knežević, University of Zagreb
- Investigators
- Marko Granić, DMD,PhD, Study chair, Second authorTihomir Kuna, DMD, PhD, Study chair, Third authorDinko Knežević, DMD, Study chair, fourth authorNino Grgić, DMD, Study chair, fifth author
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03130933
- Sponsor's protocol ID
- SCHOOL OF DENTAL MEDICINE
- Status last verified
- Jun 2017
- First submitted
- 17 Apr 2017
- Last updated
- 16 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 25191064Chuang 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.
PubMed 18940482Baqain 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.2008.06.047.
PubMed 18940492Chuang 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. doi: 10.1016/j.joms.2007.04.019.
PubMed 17719384Arteagoitia MI, Barbier L, Santamaria J, Santamaria 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 Cir Bucal. 2016 Jul 1;21(4):e494-504. doi: 10.4317/medoral.21139.
PubMed 26946211Seymour RA, Walton JG. Pain control after third molar surgery. Int J Oral Surg. 1984 Dec;13(6):457-85. doi: 10.1016/s0300-9785(84)80017-4.
PubMed 6150903Batinjan 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 Maxillofac Surg. 2014 Dec;43(12):1503-8. doi: 10.1016/j.ijom.2014.09.003. Epub 2014 Sep 29.
PubMed 25277807Dodson TB. HIV status and the risk of post-extraction complications. J Dent Res. 1997 Oct;76(10):1644-52. doi: 10.1177/00220345970760100501.
PubMed 9326896Dodson TB. Predictors of postextraction complications in HIV-positive patients. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1997 Nov;84(5):474-9. doi: 10.1016/s1079-2104(97)90260-2.
PubMed 9394376Halpern 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. doi: 10.1016/j.joms.2006.10.016.
PubMed 17236918Falconer DT, Roberts EE. Report of an audit into third molar exodontia. Br J Oral Maxillofac Surg. 1992 Jun;30(3):183-5. doi: 10.1016/0266-4356(92)90154-b.
PubMed 1622965Crincoli 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(1):e12-6. doi: 10.7471/CT.2014.1665.
PubMed 24589954Lockhart 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. doi: 10.1161/01.CIR.0000129303.90488.29. Epub 2004 Jun 1.
PubMed 15173031Hall 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. doi: 10.1093/jac/37.4.783.
PubMed 8722544Yoshii 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 prophylaxis with lenampicillin. J Infect Chemother. 2002 Mar;8(1):87-93. doi: 10.1007/s101560200012.
PubMed 11957126
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does a Single Dose of Systemic Antibiotics Prevent Postoperative Inflammatory Complications After Lower Third Molar Surgery? A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03130933
- Acronym / sponsor ID
- SCHOOL OF DENTAL MEDICINE
- Conditions
- Postoperative Complications, Third Molar
- Keywords
- third molar, oral surgical procedures, antibiotic prophylaxis, placebo effect
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University of ZagrebUniversity, hospital or other
- Study start
- Apr 2010 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 27 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- A RANDOMIZED CONTROLLED TRIAL
| Arm | Type | Receives |
|---|---|---|
| The first tested subgroup | Active comparator | Procedure: Lower third molar surgery, Drug: Amoxicillin 500 MgThe 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. |
| The first control subgroup | Placebo comparator | Procedure: Lower third molar surgery, Other: PlaceboThe control subgroup from the main group without prior inflammation received a placebo one hour prior the lower third molar surgery . |
| The second tested subgroup | Active comparator | Procedure: Lower third molar surgery, Drug: Amoxicillin 500 MgThe 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 . |
| The second control subgroup | Placebo comparator | Procedure: Lower third molar surgery, Other: PlaceboThe control subgroup from the main group with prior inflammation received a placebo one hour prior the lower third molar surgery . |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- systematically healthy subjects between 18 to 40 years (both gender) and having semi-impacted lower third molars indicated for surgical removal
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lower third molar surgeryAll 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. | Procedure or surgery | The first control subgroup, The first tested subgroup, The second control subgroup, The second tested subgroup |
| Amoxicillin 500 MgAlso: prophylaxisThe tested subgroups received a prophylactic single dose of 4 x 500 Mg Amoxicillin one hour prior the lower third molar surgery. | Drug | The first tested subgroup, The second tested subgroup |
| PlaceboThe control subgroups received a prophylactic single dose of placebo one hour prior the lower third molar surgery. | Other | The first control subgroup, The second control subgroup |
Primary outcome
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).
5 secondary outcomes
Swelling
Time frame: 1 day and 7 days after surgery
Wound healing ( AO, SSI )
Time frame: 1 day and 7 days after surgery
Maximum inter-incisal opening of mouth
Time frame: 1 day and 7 days after surgery
Increased body temperature
Time frame: through 7 days
Hemorrhage
Time frame: through 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2017.
- Results publication: PubMed 25191064Bahl 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.
- Results publication: PubMed 18940482Chuang 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.
- Results publication: PubMed 18940492Baqain 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.2008.06.047.
- Results publication: PubMed 17719384Chuang 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. doi: 10.1016/j.joms.2007.04.019.
- Results publication: PubMed 26946211Arteagoitia MI, Barbier L, Santamaria J, Santamaria 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 Cir Bucal. 2016 Jul 1;21(4):e494-504. doi: 10.4317/medoral.21139.
- Results publication: PubMed 6150903Seymour RA, Walton JG. Pain control after third molar surgery. Int J Oral Surg. 1984 Dec;13(6):457-85. doi: 10.1016/s0300-9785(84)80017-4.
- Results publication: PubMed 25277807Batinjan 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 Maxillofac Surg. 2014 Dec;43(12):1503-8. doi: 10.1016/j.ijom.2014.09.003. Epub 2014 Sep 29.
- Results publication: PubMed 9326896Dodson TB. HIV status and the risk of post-extraction complications. J Dent Res. 1997 Oct;76(10):1644-52. doi: 10.1177/00220345970760100501.
- Results publication: PubMed 9394376Dodson TB. Predictors of postextraction complications in HIV-positive patients. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1997 Nov;84(5):474-9. doi: 10.1016/s1079-2104(97)90260-2.
- Results publication: PubMed 17236918Halpern 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. doi: 10.1016/j.joms.2006.10.016.
- Results publication: PubMed 1622965Falconer DT, Roberts EE. Report of an audit into third molar exodontia. Br J Oral Maxillofac Surg. 1992 Jun;30(3):183-5. doi: 10.1016/0266-4356(92)90154-b.
- Results publication: PubMed 24589954Crincoli 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(1):e12-6. doi: 10.7471/CT.2014.1665.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marko Granić, DMD,PhD study chair
Second author
Tihomir Kuna, DMD, PhD study chair
Third author
Dinko Knežević, DMD study chair
fourth author
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Lower third molar surgery and Amoxicillin 500 Mg in people with Postoperative Complications and Third Molar, run by University of Zagreb at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (time frame: 1 day and 7 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03130933, which also lists 33 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2017.