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

Periodontal Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02185209
• Other study ID #: PERI-IMPL
• Status: Completed
• Phase: Phase 4
• Start date: March 2015
• Est. completion date: May 27, 2022

Study information

• Verified date: August 2022
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: May 27, 2022
• Est. primary completion date: May 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Peri-Implantitis
• Periimplantitis
• Periodontal Diseases

Intervention

Drug:
• Placebo
Place capsule to mimic antibiotics
• Amoxicillin Sandoz
Tablet 500 mg amoxicillin Sandoz three times a day
• Metronidazole Sanofi
400 mg metronidazole Sanofi administered three times a day (TID)
• Phenoxymethylpenicillin Meda
1600 mg phenoxymethylpenicillin Meda, three time a day (TID)

Locations

Country	Name	City	State
Sweden	Folktandvården Skanstull	Stockholm
Sweden	Folktandvården Kaniken	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Margareta Hultin

Country where clinical trial is conducted

Sweden, 

Outcome

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