Peri-implantitis - Reconstructive Surgical Therapy

NCT03077061 | Active Not Recruiting

• 1 other identifier: 1192-16
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

The project will evaluate the potential benefit of the use of bone replacement graft as an adjunct to surgical therapy of peri-implantitis. The project will be conducted as a two-armed randomized controlled clinical trial of 5-year duration in 7 clinical centers. 140 systemically healthy patients diagnosed with peri-implantitis will randomly assigned to be treated with or without bone replacement graft. Outcome measures include assessments of inflammation, probing depth, recession, radiological parameters and PROMs.

Conditions

Peri-Implantitis

Outcome Measures

Primary Outcomes (3)

• Treatment success (year 1)

  Absence of bleeding/suppuration on probing, probing depth ≤5 mm and ≤1 mm recession of mucosal margin

  Assessed at year 1

• Treatment success (year 3)

  Absence of bleeding/suppuration on probing, probing depth ≤5 mm and ≤1 mm recession of mucosal margin

  Assessed at year 3

• Treatment success (year 5)

  Absence of bleeding/suppuration on probing, probing depth ≤5 mm and ≤1 mm

  Assessed at year 5

Secondary Outcomes (2)

• Radiographic outcomes

  Assessed at 1, 3 and 5 years

• Patient-reported outcomes

  Prior to intervention and at 1, 3 and 5 years

Study Arms (2)

Control - Open flap debridement

ACTIVE COMPARATOR

The surgical procedure includes flap elevation, debridement of the peri-implant defect and decontamination of the implant surfaces using saline for irrigation. Flaps are replaced in their original position and carefully sutured. Patients are provided with post-surgical information and thereafter called in for regular follow-up visits.

Procedure: Open flap debridement

Test - Bone replacement graft

EXPERIMENTAL

The surgical procedure is identical to the control procedure with the exception of the application of the bone replacement graft. Following decontamination, Bio-Oss Collagen® is placed into the peri-implant bony defect. Flaps are carefully sutured and patients are provided with the same information and follow-up as patients in the control group.

Procedure: Open flap debridement; Device: Bone replacement graft

Interventions

Open flap debridement PROCEDURE

Open flap debridement using saline as irrigation

Control - Open flap debridement; Test - Bone replacement graft

Bone replacement graft DEVICE

Open flap debridement using saline as irrigation including a grafting procedure withBio-Oss Collagen®.

Also known as: Bio-Oss Collagen®

Test - Bone replacement graft

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years
• ≥1 implant (≥1 year of function) presenting with PPD ≥7 mm and BoP/Pus.
• Confirmed bone loss ≥3 mm at same implant(s)

You may not qualify if:

• Treated for peri-implantitis during previous 6 months
• Intake of systemic or local antibiotics during previous 6 months
• Systemic conditions affecting peri-implant tissues
• Systemic conditions impeding surgical intervention

Sponsors & Collaborators

• Göteborg University: lead
• Osteology Foundation: collaborator

Study Sites (1)

Department of Periodontology, Institute of Odontology

Gothenburg, 40530, Sweden

Location

Related Publications (8)

• 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

• Carcuac O, Abrahamsson I, Charalampakis G, Berglundh T. The effect of the local use of chlorhexidine in surgical treatment of experimental peri-implantitis in dogs. J Clin Periodontol. 2015 Feb;42(2):196-203. doi: 10.1111/jcpe.12332. Epub 2015 Jan 20.

  PMID: 25385434 BACKGROUND

• 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 BACKGROUND

• Derks J, Schaller D, Hakansson J, Wennstrom JL, Tomasi C, Berglundh T. Effectiveness of Implant Therapy Analyzed in a Swedish Population: Prevalence of Peri-implantitis. J Dent Res. 2016 Jan;95(1):43-9. doi: 10.1177/0022034515608832.

  PMID: 26701919 BACKGROUND

• Jepsen K, Jepsen S, Laine ML, Anssari Moin D, Pilloni A, Zeza B, Sanz M, Ortiz-Vigon A, Roos-Jansaker AM, Renvert S. Reconstruction of Peri-implant Osseous Defects: A Multicenter Randomized Trial. J Dent Res. 2016 Jan;95(1):58-66. doi: 10.1177/0022034515610056. Epub 2015 Oct 8.

  PMID: 26450511 BACKGROUND

• Khoshkam V, Chan HL, Lin GH, MacEachern MP, Monje A, Suarez F, Giannobile WV, Wang HL. Reconstructive procedures for treating peri-implantitis: a systematic review. J Dent Res. 2013 Dec;92(12 Suppl):131S-8S. doi: 10.1177/0022034513509279. Epub 2013 Oct 24.

  PMID: 24158331 BACKGROUND

• Roccuzzo M, Gaudioso L, Lungo M, Dalmasso P. Surgical therapy of single peri-implantitis intrabony defects, by means of deproteinized bovine bone mineral with 10% collagen. J Clin Periodontol. 2016 Mar;43(3):311-8. doi: 10.1111/jcpe.12516. Epub 2016 Mar 9.

  PMID: 26800389 BACKGROUND

• Wohlfahrt JC, Lyngstadaas SP, Ronold HJ, Saxegaard E, Ellingsen JE, Karlsson S, Aass AM. Porous titanium granules in the surgical treatment of peri-implant osseous defects: a randomized clinical trial. Int J Oral Maxillofac Implants. 2012 Mar-Apr;27(2):401-10.

  PMID: 22442781 BACKGROUND

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Tord Berglundh, Professor

  Göteborg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Individuals assessing radiographic parameters will be masked to the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is designed as a two-arm randomized clinical trial.

Study Record Dates

• First Submitted: February 24, 2017
• First Posted: March 10, 2017
• Study Start: April 1, 2017
• Primary Completion: March 14, 2022
• Study Completion: March 14, 2026
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)