Surgical Treatment of Peri-implantitis

NCT01857804 | Completed Phase 4

• 1 other identifier: olivier1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this randomized controlled clinical trial is to evaluate the outcome of treatment of peri-implantitis with or without systemic antibiotics. Specific aims are to analyze (i) the effect of systemic antibiotics and local antiseptics on the healing process, and (ii) the risk for recurrence of disease following surgical treatment of peri-implantitis.

Conditions

Peri-Implantitis

Keywords

peri-implantitis; surgical therapy; systemic antibiotics; local antiseptics

Outcome Measures

Primary Outcomes (2)

• pocket closure

  absence of probing pocket depth \> 5 mm and no bleeding on probing

  6 months, 1 year

• bone level stability

  no further peri-implant marginal bone loss in the observation period.

  1 year

Secondary Outcomes (1)

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

  3 months, 6 months, 1 year

Study Arms (4)

antibiotics and local antiseptics

EXPERIMENTAL

systemic antibiotics (2 x 750mg amoxicillin/day) + implant surface decontamination with chlorhexidine gluconate 0,2%

Drug: Amoxicillin; Drug: Chlorhexidine gluconate

antibiotics without local antiseptics

EXPERIMENTAL

systemic antibiotics (2 x 750mg amoxicillin/day) + implant surface decontamination with saline

Drug: Amoxicillin

local antiseptics no antibiotics

EXPERIMENTAL

no systemic antibiotics + implant surface decontamination with chlorhexidine gluconate 0,2%

Drug: Chlorhexidine gluconate

no antibiotics and no local antiseptics

PLACEBO COMPARATOR

no systemic antibiotics + implant surface decontamination with saline

Drug: Saline

Interventions

Amoxicillin DRUG

In the test group a systemic antibiotic regimen will be initiated at 3 days before surgery and continued for 10 days. (2 x 750mg amoxicillin/day or 2 x 1g amoxicillin/day depending on the weight of the patient)

Also known as: systemic antibiotics

antibiotics and local antiseptics; antibiotics without local antiseptics

Chlorhexidine gluconate DRUG

The exposed implant surfaces will be cleaned 3 minutes with antiseptics (chlorhexidine gluconate 0,2%) during the surgical treatment

Also known as: chlorhexidine gluconate 0,2%

antibiotics and local antiseptics; local antiseptics no antibiotics

Saline DRUG

The exposed implant surfaces will be cleaned 3 minutes with saline during the surgical treatment

no antibiotics and no local antiseptics

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• peri-implant probing pocket depth \> 7 mm on at least one aspect of the implant, together with BOP and/or suppuration,
• marginal bone loss \> 3mm as detected in radiographs.

You may not qualify if:

• implant mobility,
• peri-implantitis associated bone defects not suitable for pocket elimination therapy,
• systemic diseases that could influence the outcome of the therapy,
• penicillin allergy.

Sponsors & Collaborators

• Göteborg University: lead
• The Swedish Research Council: collaborator

Study Sites (1)

Department of Periodontology, Institute of Odontology, Sahlgrenska Academy, University of Gothenburg

Gothenburg, 40530, Sweden

Location

Related Publications (13)

• Albouy JP, Abrahamsson I, Persson LG, Berglundh T. Implant surface characteristics influence the outcome of treatment of peri-implantitis: an experimental study in dogs. J Clin Periodontol. 2011 Jan;38(1):58-64. doi: 10.1111/j.1600-051X.2010.01631.x. Epub 2010 Nov 24.

  PMID: 21092053 BACKGROUND

• Ericsson I, Persson LG, Berglundh T, Edlund T, Lindhe J. The effect of antimicrobial therapy on periimplantitis lesions. An experimental study in the dog. Clin Oral Implants Res. 1996 Dec;7(4):320-8. doi: 10.1034/j.1600-0501.1996.070404.x.

  PMID: 9151598 BACKGROUND

• Gualini F, Berglundh T. Immunohistochemical characteristics of inflammatory lesions at implants. J Clin Periodontol. 2003 Jan;30(1):14-8. doi: 10.1034/j.1600-051x.2003.300103.x.

  PMID: 12702106 BACKGROUND

• Leonhardt A, Dahlen G, Renvert S. Five-year clinical, microbiological, and radiological outcome following treatment of peri-implantitis in man. J Periodontol. 2003 Oct;74(10):1415-22. doi: 10.1902/jop.2003.74.10.1415.

  PMID: 14653386 BACKGROUND

• Mombelli A, Feloutzis A, Bragger U, Lang NP. Treatment of peri-implantitis by local delivery of tetracycline. Clinical, microbiological and radiological results. Clin Oral Implants Res. 2001 Aug;12(4):287-94. doi: 10.1034/j.1600-0501.2001.012004287.x. English, French, German.

  PMID: 11488856 BACKGROUND

• Mombelli A, Lang NP. Antimicrobial treatment of peri-implant infections. Clin Oral Implants Res. 1992 Dec;3(4):162-8. doi: 10.1034/j.1600-0501.1992.030402.x.

  PMID: 1298430 BACKGROUND

• Persson LG, Ericsson I, Berglundh T, Lindhe J. Guided bone regeneration in the treatment of periimplantitis. Clin Oral Implants Res. 1996 Dec;7(4):366-72. doi: 10.1034/j.1600-0501.1996.070410.x.

  PMID: 9151604 BACKGROUND

• Persson LG, Ericsson I, Berglundh T, Lindhe J. Osseintegration following treatment of peri-implantitis and replacement of implant components. An experimental study in the dog. J Clin Periodontol. 2001 Mar;28(3):258-63. doi: 10.1034/j.1600-051x.2001.028003258.x.

  PMID: 11284540 BACKGROUND

• Persson LG, Mouhyi J, Berglundh T, Sennerby L, Lindhe J. Carbon dioxide laser and hydrogen peroxide conditioning in the treatment of periimplantitis: an experimental study in the dog. Clin Implant Dent Relat Res. 2004;6(4):230-8. doi: 10.1111/j.1708-8208.2004.tb00039.x.

  PMID: 15841583 BACKGROUND

• Wetzel AC, Vlassis J, Caffesse RG, Hammerle CH, Lang NP. Attempts to obtain re-osseointegration following experimental peri-implantitis in dogs. Clin Oral Implants Res. 1999 Apr;10(2):111-9. doi: 10.1034/j.1600-0501.1999.100205.x.

  PMID: 10219130 BACKGROUND

• Adly MS, Adly AS, Rasheed AM, Adly AS. CAN COMBINING LOW LEVEL LASER THERAPY WITH COMPUTER GUIDED FLAPLESS PIEZOSURGICAL OSTEOTOMY ACHIEVE A PAINLESS IMPLANT SURGERY? FINDINGS OF SPLIT MOUTH RANDOMIZED CONTROLLED TRIAL. J Evid Based Dent Pract. 2022 Sep;22(3):101730. doi: 10.1016/j.jebdp.2022.101730. Epub 2022 Apr 18.

  PMID: 36162887 DERIVED

• Graziani F, Cei S, Orlandi M, Gennai S, Gabriele M, Filice N, Nisi M, D'Aiuto F. Acute-phase response following full-mouth versus quadrant non-surgical periodontal treatment: A randomized clinical trial. J Clin Periodontol. 2015 Sep;42(9):843-852. doi: 10.1111/jcpe.12451. Epub 2015 Oct 1.

  PMID: 26309133 DERIVED

• Carcuac O, Derks J, Charalampakis G, Abrahamsson I, Wennstrom J, Berglundh T. Adjunctive Systemic and Local Antimicrobial Therapy in the Surgical Treatment of Peri-implantitis: A Randomized Controlled Clinical Trial. J Dent Res. 2016 Jan;95(1):50-7. doi: 10.1177/0022034515601961. Epub 2015 Aug 18.

  PMID: 26285807 DERIVED

MeSH Terms

Conditions

Peri-Implantitis

Interventions

Amoxicillin; chlorhexidine gluconate; Sodium Chloride

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Tord Berglundh, Professor

  Department of Periodontology, Institute of Odontology, The sahlgrenska academy, University of Gothenburg

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: May 16, 2013
• First Posted: May 20, 2013
• Study Start: January 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: November 13, 2014

Record last verified: 2014-11

Locations

SE (1)