Surgical Treatment of Peri-implantitis With and Without Systemically Adjunctive Antibiotics

Surgical Treatment of Peri-implantitis With and Without Systemically Adjunctive Antibiotics A Prospective, Double Blind, Randomized, Three Armed, Parallel, Placebo Controlled Clinical Trial

The purpose of this study is to investigate if the use of systemic adjunctive antibiotics in the treatment of periimplantitis is needed.

Study Overview

• Status: Completed
• Conditions: Periodontal Diseases; Periimplantitis
• Intervention / Treatment: Drug: Placebo; Drug: Amoxicillin Sandoz; Drug: Metronidazole Sanofi; Drug: Phenoxymethylpenicillin Meda

Detailed Description

This study will give the opportunity to draw scientifically based conclusions on the recommendations of the use of adjunctive systemic antibiotics in the treatment of peri-implantitis. This study will also be able to determine the ecological impact on the oropharyngeal and intestinal microflora between different antibiotic treatments. The lack of knowledge in this area has been highlighted by the Food and Drug Administration and The Swedish Council on Health Technology Assessment (SBU)

• Study Type: Interventional
• Enrollment (Actual): 77
• Phase: Phase 4

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, SE-118 62
    • Folktandvården Skanstull
  • Uppsala, Sweden, SE 753 09
    • Folktandvården Kaniken

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female ≥18-65 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) ≤ 25
7. Signed informed consent

Exclusion Criteria:

1. Known allergy to amoxicillin, penicillin (PcV), metronidazole or betalactamic
2. Contraindication for dental surgical treatment (i.e. immunocompromised, uncontrolled DM (B-GHb-A1C 8-9 %, 64-75 mmol/mol), osteoporosis, 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, disulfiram, lithium, busulfan, 5-fluorouracil, methotrexate, phenytoin, cyclosporine and warfarin.
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Placebo; Patients with periimplantitis undergoing surgical treatment with will receive placebo three times daily (TID)	Drug: Placebo; Place capsule to mimic antibiotics
Active Comparator: amoxicillin + metronidazole; Patients with periimplantitis undergoing surgical treatment with amoxicillin (500 mg TID) + metronidazole (400 mg TID) for 7 days	Drug: Amoxicillin Sandoz; Tablet 500 mg amoxicillin Sandoz three times a day; Drug: Metronidazole Sanofi; 400 mg metronidazole Sanofi administered three times a day (TID)
Active Comparator: phenoxymetylpencillin + metronidazol; Patients with periimplantitis undergoing surgical treatment with phenoxymetylpencillin, (800mg×2 TID) + metronidazol (400 mg TID) for 7 days	Drug: Metronidazole Sanofi; 400 mg metronidazole Sanofi administered three times a day (TID); Drug: Phenoxymethylpenicillin Meda; 1600 mg phenoxymethylpenicillin Meda, three time a day (TID)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Probing pocket depth change and bone level stability	0,6 and 12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Change of clinical soft tissue inflammation, bleeding on probing (BOP)	0, post operative 12 month
Soft tissue recession (REC) and clinical attachment level gain (CAL)	0,6 and 12 month
• Quantitative and qualitative change in levels of the peri-implant periopathogenic microflora	0,6 and 12 months
• Susceptibility changes of the oral and intestinal microflora to amoxicillin, metronidazole and penicillin.	0,6 and 12 month
Quantitative and qualitative changes in the oral and intestinal microflora	0,6 and 12 month
Concentration of amoxicillin, metronidazole and PcV in saliva and feces	0, 6 and 12 month
• Follow-up of adverse events related or unrelated to the investigated medical products	0,6, and 12 month

Collaborators and Investigators

• Sponsor: Margareta Hultin
• Investigators: Study Chair: Margareta Hultin, DDSass. prof, Karolinska Institute, Dental Medicine; Study Director: Bodil Lund, DDSass.prof, Karolinska Institute, Dental Medicine; Principal Investigator: Dalia Kahlil, DDS, PhDstud, Karolinska Institute, Dental Medicine

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): May 27, 2022
• Study Completion (Actual): May 27, 2022

Study Registration Dates

• First Submitted: June 23, 2014
• First Submitted That Met QC Criteria: July 6, 2014
• First Posted (Estimate): July 9, 2014

Study Record Updates

• Last Update Posted (Actual): August 18, 2022
• Last Update Submitted That Met QC Criteria: August 17, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontal Diseases; Peri-Implantitis; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Metronidazole; Amoxicillin; Penicillin V
• Other Study ID Numbers: PERI-IMPL