Surgical treatment of peri-implantitis with and without systemically adjunctive antibioticsA prospective, open, randomized, three armed, parallel, placebo controlled clinical trial

Karolinska Institute0 个研究点目标入组 66 人开始时间: 2014年7月25日最近更新: 2020年7月6日

适应症

试验速览

暂无简介。

•1.Male or female =18 year
•2.Patients who has been referred by a general dentist to a specialist clinic in periodontology for treatment of peri-implantitis.
•3.Having sign of peri-implantitis around at least one osseointegrated dental implant that has been in function for = one year
•4.Peri-implantitis is diagnosed when; PPD of = 6mm can be found at a dental implant in association with BOP and/or suppuration together with the loss of marginal alveolar bone of more than 2 mm detected on intraoral radiographs (giving radiographic exposure of at least = 3 fixture threads).
•5.Partially or completely edentulous subjects with healthy or treated periodontal conditions enrolled in a regular supportive program.
•6.Full-Mouth Plaque Score (FMPS) = 30
•7.Signed informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 44
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 22

•1.Known allergy to amoxicillin, penicillin (PcV), metronidazole or betalactam.
•2.Contraindication for dental surgical treatment (i.e. immunocompromised, uncontrolled DM (B-GHb-A1C 8–9 %, 64–75 mmol/mol), I.V bisphosphonate treatment due to malignancy, pregnant and lactating women).
•3.Incapability to perform basal oral hygiene measures due to physical or mental disorders.
•4.Received systemic antimicrobial therapy in the past three months.
•5.Currently on allopurinol, digoxin, disulfirom, lithium, busulfan, 5-fluorouracil, methotrexate, phenytoin, cyclosporine and warfrin.
•6.Known severe chronic peripheral or central disease of the nervous system
•7.Known alcohol abuse
•8.Known hepatic encephalopathy
•9.Known lactose intolerance, galactose intolerance
•10.Untreated periodontal condition.
•11.Implant showing sign of mobility.
•12.Implants with bone loss exceeding 2/3 of the length of the implant or implants with bone loss beyond any transverse openings in hollow implants.
•13.Any medical condition or on any concomitant medication that, in the opinion of the investigator, might interfere with the evaluation of the study objectives or jeopardize patient safety
•Patients with xerostomia or having slow bowel motion will be excluded from the group of patients providing salivary and fecal samples.

发起方

Karolinska Institute