Clinical Trials Logo

Clinical Trial Summary

Evaluation of the efficacy of amox+clav and of a probiotic after tooth extraction. the aim is to evaluate efficacy of antibiotic therapy after tooth extractions in preventing infections as compared to no therapy, and efficacy of probiotics in preventing gastro-intestinal adverse effects during the antibiotic treatment. The number of patients to be included is 150. The study products are: Amoxicillin + Clavulanic Acid and Bifidobacterium Longum and Lactoferrin.


Clinical Trial Description

The main objective of this trial is to evaluate the efficacy of the antibiotic after tooth extraction in preventing infections and to evaluate the effect of probiotic in reducing the possible antibiotic side effects. In order to analyze the effect of the antibiotic in terms of patient's general discomfort, a tailored form was prepared (Appendix A). The local signs and symptoms to evaluate are swelling, pain (assessed by the Visual Analogic Scale), presence of abscess, fever, post-extraction dental alveolitis (dry socket) and presence of trismus assessed as maximal mouth opening variation (mm). In addition adverse post-extraction events will be evaluated as follows: chewing impairments (assessed by the Visual Analogic Scale), speaking impairments (assessed by the Visual Analogic Scale), daily oral hygiene maneuvers impairments (assessed by the Visual Analogic Scale) and daily activities alterations (days-off from job/study). Moreover, the patients will be provided with a painkiller's prescription and they are required to take note of the painkillers needed during the first 7 days, i.e. until the first time point recall. The prescribed painkillers will be Ibuprofen 600 mg or naproxen sodium 500mg for those patients who reported allergy to ibuprofen. Finally, it will be a researcher duty to ask the patients if they needed to assume painkillers beyond the 7th day. Since the post-surgical sequelae depend also on the difficulty of extraction, the Appendix A provides a table in which the surgeon can take note of the type of extraction. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04082598
Study type Interventional
Source University of Pisa
Contact
Status Completed
Phase Phase 4
Start date October 1, 2016
Completion date January 30, 2019

See also
  Status Clinical Trial Phase
Terminated NCT04117568 - The Role of Emergency Neutrophils and Glycans in Postoperative and Septic Patients
Recruiting NCT04084938 - Artery Embolization vs Operation of Benign Prostate Hyperplasia N/A
Enrolling by invitation NCT03922737 - Telehealth Following Orthopaedic Procedures N/A
Not yet recruiting NCT05248139 - Safety and Effectiveness of Drop-free Small Incision Cataract Surgery N/A
Completed NCT05596552 - Comparison of Intrathecal Dexmedetomidine Versus Fentanyl as Adjuvants to Bupivacaine on Post-operative Urinary Retention in Knee Joint Arthroscopic Surgeries Phase 4
Not yet recruiting NCT04509986 - GlobalSurg-CovidSurg Week
Completed NCT04168307 - Physiotherapy Versus Use of a New Ankle Trainer Device After Ankle Fracture Operation. N/A
Recruiting NCT02980770 - Postoperative Complications in Patients With Obesity Hypoventilation Syndrome N/A
Recruiting NCT03323619 - Impact of Anesthesia Technique on Post-operative Delirium After Transcatheter Aortic Valve Implantation
Completed NCT04268576 - Impact of an Improved Rehabilitation Program After a Scheduled Hysterectomy.
Completed NCT04620850 - Effect of Acupressure on Recovery of Bowel Function in Patients Post Cesarean Section N/A
Completed NCT05592145 - Quantifying the Venous Congestion Curve of a Tissue Oximetry Device N/A
Completed NCT03192917 - Low-energy Extracorporeal Shockwave Treatment for Patients After Radical Prostatectomy N/A
Completed NCT03036072 - Delayed Rewarming for Neuroprotection in Infants Following Cardiopulmonary Bypass Surgery N/A
Completed NCT03230474 - a Small Dose of Naloxone,Minimize Intrathecal Morphine Side Effects N/A
Recruiting NCT05269368 - Interest of Wicking for Ossicular Surgery and Myringoplasty N/A
Completed NCT04301232 - Fast-Track Eligibility and Hospital Discharge for Outpatient Lumbar Discectomy
Completed NCT04700995 - Postoperative Pain After Using NiTi Instruments N/A
Recruiting NCT06050551 - Pigtail or Chest Tube Placement After Uniportal Video-assisted Thoracoscopic Surgery N/A
Recruiting NCT04826575 - Pre-habilitation in Lung Surgery Candidates N/A