Flapless Surgical Treatment of Peri-implantitis

NCT06093360 | Completed

• 1 other identifier: UCM ACA 2
• Study Type: observational
• Target: 117
• Locations: 1 country
• Sites: 1

Brief Summary

Aim: To evaluate the effectiveness of a flapless surgical approach in the treatment of peri-implantitis and to explore the factors influencing disease resolution. Material and Methods: This case series involved patients with at least one implant diagnosed with peri-implantitis treated with a flapless surgical approach. Treatment consisted on mechanical debridement and chemical decontamination of the implant surface plus mucosal curettage combined with/without systemic antimicrobials and/or prostheses modification. Follow-up visits for supportive peri-implant care (SPIC) were scheduled at 6 and 12 weeks, and then every 3 months during the first 12 months. Clinical and radiographic parameters were assessed at baseline, 3 months and 12 months. Disease resolution defined as residual probing depths \< 5 mm, ≤ 1 point of BOP, absence of suppuration and absence of progressive bone loss compared to pre-treatment bone levels was the main outcome variable. Multilevel regression analyses was used to identify predictors affecting the probability of disease resolution.

Conditions

Peri-Implantitis

Keywords

treatment; systemic antimicrobials

Outcome Measures

Primary Outcomes (1)

• Disease resolution percentage

  Percentage of implants that achieve disease resolution, defined as:probing depths \< 5 mm + \< 1 point of bleeding on probing (BOP) + absence of suppuration and absence of progressive bone loss compared to pre-treatment bone levels

  12 months, 60 months

Secondary Outcomes (30)

• Probing deph

  baseline, 3 months, 12 months, 60 months

• bleeding on probing

  baseline, 3 months, 12 months, 60 months

• recession

  baseline, 3 months, 12 months, 60 months

• suppuration

  baseline, 3 months, 12 months, 60 months

• marginal bone levels

  Baseline, 12 months

Study Arms (1)

flapless group

Patients were treated in 1-2 sessions within a period of 7 days, with a minimum of 90 minutes per session. Implant-supported restorations were unscrewed and modified if they were not cleansable. After local anesthesia, a periodontal ultrasonic stainless-steel tip was used for supra- and sub-mucosal mechanical debridement . Next, a Columbia 4R/4L curette was used around the implant in a circular motion until a bone exposure of 2-3 mm was achieved. Mucosal curettage was performed. After obtaining access to the implant surface, ultrasonic instrumentation was repeated and air polishing with an erythritol powder was applied submucosally with the aim of a periodontal probe. Hydrogen peroxide 3% was used to irrigate the implant surface for 2 minutes, followed by a rinse with saline. Systemic antibiotics, when prescribed, were metronidazole or azithromycin.

Procedure: flapless surgery

Interventions

flapless surgery PROCEDURE

Implant-supported restorations were unscrewed and modified if necessary (biofilm control). All the restorations were relocated at the end of each intervention session. After local anesthesia, a periodontal ultrasonic stainless-steel tip was used for supra- and sub-mucosal mechanical debridement. Next, a Columbia 4R/4L curette was used around the implant in a circular motion until a bone exposure of 2-3 mm was achieved. Mucosal curettage was simultaneously performed to remove the granulation tissue. After obtaining access to the implant surface, ultrasonic instrumentation was repeated and air polishing with an erythritol powder was applied submucosally with the aim of a periodontal probe. Hydrogen peroxide 3% was used to irrigate the implant surface for 2 minutes, followed by a rinse with saline. Oral hygiene instructions were given. Systemic antibiotics, when prescribed, were metronidazole or azithromycin

flapless group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients diagnosed with peri-implantitis in need of treatment

You may qualify if:

• \> 18 years old
• presence before treatment of at least one implant diagnosed with peri-implantitis following the case definition of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions, defined as probing pocket depth \> 6 mm combined with bleeding on probing and/or suppuration and progressive bone loss in relation to the radiographic bone level assessment at 1 year following the delivery of the implant-supported prosthetics reconstruction. In the absence of initial radiographs, radiographic evidence of bone level ≥3 mm was considered; - follow-up period after treatment of at least 12 months

You may not qualify if:

• pregnant or breast-feeding
• had systemic contraindications to receive treatment
• had presence of implant-supported removable overdentures
• present implant mobility before treatment
• present inability or unwillingness to give informed consent.

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

Study Sites (1)

Ana Carrillo de Albornoz

Madrid, 28040, Spain

Location

Related Publications (1)

• Herrera D, Berglundh T, Schwarz F, Chapple I, Jepsen S, Sculean A, Kebschull M, Papapanou PN, Tonetti MS, Sanz M; EFP workshop participants and methodological consultant. Prevention and treatment of peri-implant diseases-The EFP S3 level clinical practice guideline. J Clin Periodontol. 2023 Jun;50 Suppl 26:4-76. doi: 10.1111/jcpe.13823. Epub 2023 Jun 4.

  PMID: 37271498 RESULT

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Flapless surgical approach in the treatment of peri-implantitis.

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: October 23, 2023
• Study Start: January 1, 2018
• Primary Completion: January 1, 2023
• Study Completion: June 1, 2023
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)