Treatment efficacy of locally delivered metronidazole combined with minocycline for nonsurgical treatment of periimplantitis
- Conditions
- Certain infectious and parasitic diseases
- Registration Number
- KCT0004557
- Lead Sponsor
- Yonsei University Health System, Dental Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 120
1) Adult patient aged 19 years or older who voluntarily agrees in writing after receiving sufficient explanation about the purpose, contents and characteristics of the study drug.
2) Patients with at least one implant that meets the criteria for diagnosis of peri-implantitis
· Diagnosis criteria of peri-implantitis: PD = 5 mm13, 14 at 1 site or more during 6-segment measurement, bleeding (BOP) or suppuration at the time of probe, inflammatory of marginal bone around the implant compared to the time of implantation Patients deemed to have had bone loss
If there is no radiograph for baseline setting at screening time, peri-implantitis was diagnosed as the progression of bone loss above the reference mark, depending on the implant system and type. Reference points for the implant system are as follows
Branemark type: first thread
Straumann type: 2.8 mm (standard) / 1.8 mm (standard plus) below implant shoulder
3.Astra tech type: 1.8 mm downward from implant shoulder
3) Those who have passed at least 1 year after the implantation of peri-implantitis at the time of screening
1) Patients who showed improvement after undergoing surgical treatment for the implant that developed peri-implantitis selected in this study
2) Those who have taken 5 or more consecutive days of drugs (phenytoin, calcium channel blocker, cyclosporin, coumarin, nonsteroidal anti-inflammatory drugs, and aspirin) that may affect the periodontal state within one month before the first dose (except If you are taking calcium channel blocker, aspirin (low doses of 100 mg or less per day), you may participate in this trial if you have been taking the dose for one month prior to the first dosing date without any changes in usage.
3) Those who have taken or administered antibiotics such as minocycline, metronidazole, doxycycline within one month before the first dose or periodontal disease treatment such as zea mays L L. extract, igatan, doxycycline within 3 weeks
4) Those who require surgery, extractions or other dental treatments due to the accompanying dental disease during the trial period.
5) Persons with a history of hypersensitivity to Tetracycline-based drugs and metronidazole
6) Those who have diseases such as uncontrolled high blood pressure and diabetes
7) A person with uncontrolled hemorrhagic history or disease.
8) Those who are taking warfarin or who cannot be prohibited during the trial
9) Those who are taking medications or who are prohibited from taking drugs containing disulfiram ingredients.
10) Clinically significant chronic infections (acquired immune deficiency syndrome (AIDS), etc.), liver, kidneys, cardiovascular system, respiratory system, endocrine system, blood and tumor, urinary system, mental system, digestive system, autoimmune diseases Have or have a medical history
11) Smokers (smoking at least 10 cigarettes a day)
12) Excessive alcohol intake (one with a regular history of alcohol intake exceeding 210 g / week within 6 months of screening (1 beer (5%) = 250 g) = 10 g, 1 glass of soju (20%) mL) = 8 g, 1 glass of wine (12%) (125 mL) = 12 g)
13) Pregnant or lactating
14) Women identified as 'positive' on pre-randomization pregnancy test
15) Physical blocking methods used with women of childbearing potential who are unable or unwilling to use appropriate contraceptive methods to avoid pregnancy during the 4 weeks of administration (appropriate contraception: intrauterine devices (eg loops, mirenas), chemical barriers (spermicides). , Subcutaneous implant contraceptives (such as implanone), fallopian surgery or laparoscopic contraception (a type of tubal ligation)
16) Those who have participated in other clinical trials within 1 month before the first dose
17) illiterate or alien (who cannot voluntarily read or understand written consent)
18) In addition to the above, the investigator (doctor) judges that he / she is not suitable for participation in this clinical trial.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pocket probing depth
- Secondary Outcome Measures
Name Time Method Bleeding on probing;Bacterial counts