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

NCT02185209 | Completed Phase 4

• 1 other identifier: PERI-IMPL
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Periodontal Diseases; Periimplantitis

Outcome Measures

Primary Outcomes (1)

• Probing pocket depth change and bone level stability

  0,6 and 12 months

Secondary Outcomes (7)

• 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

Study Arms (3)

Placebo

EXPERIMENTAL

Patients with periimplantitis undergoing surgical treatment with will receive placebo three times daily (TID)

Drug: Placebo

amoxicillin + metronidazole

ACTIVE COMPARATOR

Patients with periimplantitis undergoing surgical treatment with amoxicillin (500 mg TID) + metronidazole (400 mg TID) for 7 days

Drug: Amoxicillin Sandoz; Drug: Metronidazole Sanofi

phenoxymetylpencillin + metronidazol

ACTIVE COMPARATOR

Patients with periimplantitis undergoing surgical treatment with phenoxymetylpencillin, (800mg×2 TID) + metronidazol (400 mg TID) for 7 days

Drug: Metronidazole Sanofi; Drug: Phenoxymethylpenicillin Meda

Interventions

Placebo DRUG

Place capsule to mimic antibiotics

Placebo

Amoxicillin Sandoz DRUG

Tablet 500 mg amoxicillin Sandoz three times a day

amoxicillin + metronidazole

Metronidazole Sanofi DRUG

400 mg metronidazole Sanofi administered three times a day (TID)

amoxicillin + metronidazole; phenoxymetylpencillin + metronidazol

Phenoxymethylpenicillin Meda DRUG

1600 mg phenoxymethylpenicillin Meda, three time a day (TID)

phenoxymetylpencillin + metronidazol

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female ≥18-65 year
• Patients who has been referred by a general dentist to a specialist clinic in periodontology for treatment of peri-implantitis.
• Having sign of peri-implantitis around at least one osseointegrated dental implant that has been in function for ≥ one year
• 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).
• Partially or completely edentulous subjects with healthy or treated periodontal conditions enrolled in a regular supportive program.
• Full-Mouth Plaque Score (FMPS) ≤ 25
• Signed informed consent

You may not qualify if:

• Known allergy to amoxicillin, penicillin (PcV), metronidazole or betalactamic
• 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).
• Incapability to perform basal oral hygiene measures due to physical or mental disorders.
• Received systemic antimicrobial therapy in the past three months.
• Currently on allopurinol, digoxin, disulfiram, lithium, busulfan, 5-fluorouracil, methotrexate, phenytoin, cyclosporine and warfarin.
• Known severe chronic peripheral or central disease of the nervous system
• Known alcohol abuse
• Known hepatic encephalopathy
• Known lactose intolerance, galactose intolerance
• Untreated periodontal condition.
• Implant showing sign of mobility.
• 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.
• 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.

Sponsors & Collaborators

• Margareta Hultin: lead

Study Sites (2)

Folktandvården Skanstull

Stockholm, SE-118 62, Sweden

Location

Folktandvården Kaniken

Uppsala, SE 753 09, Sweden

Location

Related Publications (1)

• Riben Grundstrom C, Lund B, Kampe J, Belibasakis GN, Hultin M. Systemic antibiotics in the surgical treatment of peri-implantitis: A randomized placebo-controlled trial. J Clin Periodontol. 2024 Aug;51(8):981-996. doi: 10.1111/jcpe.13994. Epub 2024 May 3.

  PMID: 38699828 DERIVED

MeSH Terms

Conditions

Periodontal Diseases; Peri-Implantitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Margareta Hultin, DDSass. prof

  Karolinska Institute, Dental medicine

  STUDY CHAIR

• Bodil Lund, DDSass.prof

  Karolinska Institute, Dental Medicine

  STUDY DIRECTOR

• Dalia Kahlil, DDS, PhDstud

  Karolinska Institute, Dental Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: DDS

Study Record Dates

• First Submitted: June 23, 2014
• First Posted: July 9, 2014
• Study Start: March 1, 2015
• Primary Completion: May 27, 2022
• Study Completion: May 27, 2022
• Last Updated: August 18, 2022

Record last verified: 2022-08

Locations

SE (2)