Surgical Treatment of Peri-implantitis

NCT03163602 | Completed

• 1 other identifier: 15-116
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this randomized controlled study is to evaluate the outcome of surgical treatment of peri-implantitis with and without the use of a bone substitute graft covered by a collagen membrane. There will be a follow up period of 12 months. Outcome measures will include assessments of inflammation, probing depth, recession, radiological parameters and PROMs.

Conditions

Peri-Implantitis

Keywords

Peri-Implantitis; Infection; Bone substitutes

Outcome Measures

Primary Outcomes (1)

• Composite Success Outcome

  Number of participants with treated implant with successful outcome: no bleeding or suppuration on probing, no further bone loss, PD ≤ 5 mm

  12 months

Secondary Outcomes (4)

• probing depth change

  12 months

• radiographic bone level change

  12 months

• change in peri-implant soft tissue level

  12 months

• patient reported outcomes

  1, 6, 12 months

Study Arms (2)

Control Group 1

ACTIVE COMPARATOR

Access flap, implant surface decontamination (saline), systemic antibiotics (amoxicillin 500 mg and metronidazole 400 g, 3 x day for 7 days)

Drug: Control group

Test Group 2

ACTIVE COMPARATOR

Access flap, implant surface debridement, systemic antibiotics (amoxicillin 500 mg, metronidazole 400 g, 3 x day for 7 days), bovine bone substitute material (BioOss®) and collagen membrane (BioGide®)

Device: Test group

Interventions

Control group DRUG

Access flap and debridement

Also known as: Access flap and debridement

Control Group 1

Test group DEVICE

Regenerative treatment

Also known as: BioOss®, BioGide® collagen membrane

Test Group 2

Eligibility Criteria

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

You may qualify if:

• Presence of ≥ 1 implant with a probing depth (PD) ≥ 5 mm with bleeding and/or suppuration (SUP) on probing, and peri-implant bone loss ≥ 3mm with an intraosseous defect component

You may not qualify if:

• Smokers \> 10 cigarettes per day
• Patients with uncontrolled diabetes mellitus
• Pregnant or lactating women (self reported)
• Patients with a systemic illness that preclude them from oral surgery
• Patients with an allergy to amoxicillin or metronidazole or chlorhexidine.
• Patients requiring antibiotic prophylaxis and Patients who have taken antibiotics in the past 3 months

Sponsors & Collaborators

• The University of Western Australia: lead
• Osteology Foundation: collaborator

Study Sites (1)

The University of Western Australia

Perth, Western Australia, 6009, Australia

Location

Related Publications (5)

• Esposito M, Grusovin MG, Worthington HV. Treatment of peri-implantitis: what interventions are effective? A Cochrane systematic review. Eur J Oral Implantol. 2012;5 Suppl:S21-41.

  PMID: 22834392 BACKGROUND

• Heitz-Mayfield LJ, Mombelli A. The therapy of peri-implantitis: a systematic review. Int J Oral Maxillofac Implants. 2014;29 Suppl:325-45. doi: 10.11607/jomi.2014suppl.g5.3.

  PMID: 24660207 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

• Heitz-Mayfield LJA, Salvi GE, Mombelli A, Loup PJ, Heitz F, Kruger E, Lang NP. Supportive peri-implant therapy following anti-infective surgical peri-implantitis treatment: 5-year survival and success. Clin Oral Implants Res. 2018 Jan;29(1):1-6. doi: 10.1111/clr.12910. Epub 2016 Jun 23.

  PMID: 27335316 BACKGROUND

• Heitz-Mayfield LJA, Heitz F, Koong B, Huang T, Chivers P. Surgical peri-implantitis treatment with and without guided bone regeneration. A randomized controlled trial. Clin Oral Implants Res. 2023 Sep;34(9):892-910. doi: 10.1111/clr.14116. Epub 2023 Jun 29.

  PMID: 37382408 DERIVED

MeSH Terms

Conditions

Peri-Implantitis; Infections

Interventions

Control Groups; Debridement

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Surgical Procedures, Operative

Study Officials

• Lisa Heitz-Mayfield, OdontDr

  The University of Western Australia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adj Professor

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: April 14, 2017
• First Posted: May 23, 2017
• Study Start: May 15, 2017
• Primary Completion: September 6, 2021
• Study Completion: September 6, 2021
• Last Updated: August 5, 2022

Record last verified: 2022-08

Locations

AU (1)