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

Primary Purpose

Periodontal Diseases, Periimplantitis

Status

Completed

Phase

Phase 4

Locations

Sweden

Study Type

Interventional

Intervention

Placebo

Amoxicillin Sandoz

Metronidazole Sanofi

Phenoxymethylpenicillin Meda

About this trial

This is an interventional treatment trial for Periodontal Diseases

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.

Sites / Locations

Folktandvården Skanstull
Folktandvården Kaniken

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Placebo

amoxicillin + metronidazole

phenoxymetylpencillin + metronidazol

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Probing pocket depth change and bone level stability

Secondary Outcome Measures

Change of clinical soft tissue inflammation, bleeding on probing (BOP)

Soft tissue recession (REC) and clinical attachment level gain (CAL)

• Quantitative and qualitative change in levels of the peri-implant periopathogenic microflora

• Susceptibility changes of the oral and intestinal microflora to amoxicillin, metronidazole and penicillin.

Quantitative and qualitative changes in the oral and intestinal microflora

Concentration of amoxicillin, metronidazole and PcV in saliva and feces

• Follow-up of adverse events related or unrelated to the investigated medical products

Full Information

NCT ID

NCT02185209

First Posted

June 23, 2014

Last Updated

August 17, 2022

Sponsor

Margareta Hultin

1. Study Identification

Unique Protocol Identification Number

NCT02185209

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Completed

Study Start Date

March 2015 (undefined)

Primary Completion Date

May 27, 2022 (Actual)

Study Completion Date

May 27, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Margareta Hultin

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Periodontal Diseases, Periimplantitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

77 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Experimental

Arm Description

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

Arm Title

amoxicillin + metronidazole

Arm Type

Active Comparator

Arm Description

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

Arm Title

phenoxymetylpencillin + metronidazol

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Place capsule to mimic antibiotics

Intervention Type

Drug

Intervention Name(s)

Amoxicillin Sandoz

Intervention Description

Tablet 500 mg amoxicillin Sandoz three times a day

Intervention Type

Drug

Intervention Name(s)

Metronidazole Sanofi

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Phenoxymethylpenicillin Meda

Intervention Description

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

Primary Outcome Measure Information:

Title

Probing pocket depth change and bone level stability

Time Frame

0,6 and 12 months

Secondary Outcome Measure Information:

Title

Change of clinical soft tissue inflammation, bleeding on probing (BOP)

Time Frame

0, post operative 12 month

Title

Soft tissue recession (REC) and clinical attachment level gain (CAL)

Time Frame

0,6 and 12 month

Title

• Quantitative and qualitative change in levels of the peri-implant periopathogenic microflora

Time Frame

0,6 and 12 months

Title

• Susceptibility changes of the oral and intestinal microflora to amoxicillin, metronidazole and penicillin.

Time Frame

0,6 and 12 month

Title

Quantitative and qualitative changes in the oral and intestinal microflora

Time Frame

0,6 and 12 month

Title

Concentration of amoxicillin, metronidazole and PcV in saliva and feces

Time Frame

0, 6 and 12 month

Title

• Follow-up of adverse events related or unrelated to the investigated medical products

Time Frame

0,6, and 12 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Margareta Hultin, DDSass. prof

Organizational Affiliation

Karolinska Institute, Dental medicine

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Bodil Lund, DDSass.prof

Organizational Affiliation

Karolinska Institute, Dental Medicine

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Dalia Kahlil, DDS, PhDstud

Organizational Affiliation

Karolinska Institute, Dental Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Folktandvården Skanstull

City

Stockholm

ZIP/Postal Code

SE-118 62

Country

Sweden

Facility Name

Folktandvården Kaniken

City

Uppsala

ZIP/Postal Code

SE 753 09

Country

Sweden

12. IPD Sharing Statement

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

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