Surgical Treatment of Peri-implantitis

Peri-Implantitis Clinical Trial

— STP  

Official title:

Surgical Treatment of Peri-implantitis. A Randomised Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03163602
• Other study ID #: 15-116
• Status: Completed
• Phase: N/A
• Start date: May 15, 2017
• Est. completion date: September 6, 2021

Study information

• Verified date: August 2022
• Source: The University of Western Australia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The aim of this randomized controlled study is to evaluate the possible benefit of a regenerative treatment protocol (placing a bone substitute covered by a bioresorbable collagen membrane) compared to surgical treatment alone, for peri-implantitis therapy.

The hypothesis is that there will be a greater number of patients with successful treatment of peri-implantitis following the use of a bone substitute/collagen membrane compared to surgical peri-implantitis therapy without the bone substitute/collagen membrane.

The project will be conducted as a two-armed randomized controlled clinical trial of 1-year duration. Forty systemically healthy patients with ≥1 implant diagnosed with peri-implantitis requiring surgical therapy will be enrolled.

Baseline measurements will be performed after non-surgical therapy (removal supramucosal biofilm/calculus, oral hygiene instruction and correction of prosthetic factors) and treatment of periodontitis.

Baseline measurements will include probing depth, position of mucosal margin, presence of plaque, presence of bleeding and/or suppuration on probing, PROMs and radiographs. Measurements will be recorded at 4 sites per implant.

Following the baseline measurements participants will be randomly assigned to either Control Group (Group 1): access flap and implant cleaning or Test Group (Group 2): access flap, implant cleaning and addition of a bone substitute material covered by a collagen membrane.

Participants in both treatment groups will be prescribed systemic antimicrobials (Amoxicillin 500 mg tds and Metronidazole 400 mg tds) for 7 days starting from the day of surgery.

In addition an antibacterial mouthrinse (chlorhexidine digluconate 0.2%) will be prescribed for a period of 4 weeks following surgery.

Participants will be asked to attend follow-up visits for review of healing (week 1 and 4) and maintenance care (3, 6, 9, and 12 months).

Clinical examinations will be performed by a calibrated blinded examiner at baseline and 12 months after therapy. Clinical measurements will be taken using a periodontal probe at 4 sites per implant to record presence of plaque, bleeding, probing depth and recession of the soft tissue.

PROMS will be assessed at 1 week, 4 weeks and at 12 months. Radiographic assessments Intra-oral radiographs and cone beam CT scan will be obtained prior to surgery and at 12 months. Oral-maxillofacial radiologists will. perform the radiographic analysis and will be blinded to the treatment procedure.

Primary outcome variables include (1) resolution of peri-implantitis (probing depth reduction and absence of BoP, suppuration) (2) recurrence of disease (BoP, suppuration and increase in PPD and progression of bone loss.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 6, 2021
• Est. primary completion date: September 6, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Peri-Implantitis

Intervention

Drug:
• Control group
Access flap and debridement

Device:
• Test group
Regenerative treatment

Locations

Country	Name	City	State
Australia	The University of Western Australia	Perth	Western Australia

Sponsors (2)

Lead Sponsor	Collaborator
The University of Western Australia	Osteology Foundation

Country where clinical trial is conducted

Australia, 

References & Publications (4)

Carcuac O, Derks J, Charalampakis G, Abrahamsson I, Wennström 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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	probing depth change	mm	12 months
Secondary	radiographic bone level change	mm	12 months
Secondary	change in peri-implant soft tissue level	mm	12 months
Secondary	patient reported outcomes	VAS scores	1, 6, 12 months