Regenerative Surgical Treatment of Peri-implant Defects

Not Applicable

• Conditions: Implant Site Pocket Infection
• Interventions: Procedure: regenerative treatment periimplantitis

• Registration Number: NCT04440241
• Lead Sponsor: University of Santiago de Compostela

Brief Summary

Does submerged healing of implants improve clinical and radiologic outcomes for the treatment of peri-implantitis? A number of recent systematic reviews have shown that the prevalence of periimplantitisin the population is high.

Nevertheless, there appears to be no consensus on treatment standards for the management of peri-implant diseases. Also, the significant variation in the empirical use of the available therapeutic modalities seems to result in moderately effective treatment outcomes. Animal and human case series-studies have shown improved outcomes when using a submerged healing approach. However, there seems to be no randomized controlled clinical studies comparing submerged/non-submerged healing efficacy for the treatment of peri-implantitis. Since current modalities for the treatment of peri-implantitis seem to result inmoderately effective outcomes, there is an urgency to investigate treatment strategies that will result in improved patient's benefits in terms of health.

Detailed Description

The present study will be double-blinded randomized controlled clinical trial. Patients requiring surgical treatment of peri-implantitis after non-surgical therapy will beassigned to either:

Test group: submerged healing or Control group: non-submerged healing treatment of peri-implantitis using guided bone regeneration with a bone substitute and a resorbable membrane.

The primary aim of this study is to evaluate whether submerged healing of implants willsignificantly improve the changes in marginal bone levels measured on X-rays 12months post-treatment compared to a non-submerged healing approach for the treatment of peri-implantitis.

Secondary aims include changes in clinical attachment levels, changes in probing pocket depth, recession, keratinized tissue, occurrence of bleeding on probing, suppuration on probing (PUS), marginal gingival recession (REC), full mouth plaque score (FMPS), full mouth bleeding score (FMBS), type of peri-implant bone defect, frequency and type of complications and implant loss.

Study Timeline

• Study First Submitted: 2020-06-15
• Study First Submitted QC: 2020-06-18
• Study First Posted: 2020-06-19
• Study Start: 2021-04-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-28
• Last Update Posted: 2021-09-29
• Primary Completion: 2021-12-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Age ≥18 years.
• Systemically healthy patients.
• Presence of at least 1 implant diagnosed with peri-implantitis (peri-implant probing pocket depth ≥6 mm in at least 1 aspect of the implant with bleeding and/or suppuration on probing and radiographically documented marginal bone loss ≥3mm) according to Renvert et al. (2018), after non-surgical therapy of periimplantitis, and a 4mm deep intrabony component.
• Absence of mobility of the implants.
• Individual implant-supported crown or partial fixed implant supported restoration (removable prosthesis will be excluded).
• Patient's smoking ≤ 10 cigarettes/day.

Exclusion Criteria

• Non-removable prostheses

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	regenerative treatment periimplantitis	non submerged healing treatment of peri-implantitis using guided bone regeneration with a bone substitute and a resorbable membrane.
Test group	regenerative treatment periimplantitis	submerged healing treatment of peri-implantitis using guided bone regeneration with a bone substitute and a resorbable membrane.

Primary Outcome Measures

Name	Time	Method
Changes marginal bone level	baseline, 6 and 12 months	measured on periapical X-rays, from the shoulder of the implant to the bottom of the bone defect next to the implant at the mesial and distal surfaces. Mean marginal bone levels between mesial and distal measurements will be calculated.

Secondary Outcome Measures

Name	Time	Method
Change Keratinized mucosa	baseline, 6 and 12 months	distance from the gingival margin up to the mucogingival line.
Change blending on probing	baseline, 6 and 12 months	Registry of presence of bleeding by binary scale (1 bleed present / 0 bleed absent)
Change plaque score	baseline, 6 and 12 months	Registration of presence of plaque by binary scale on each surface (1 present / 0 absent), calculating the percentage of total surfaces in which plaque is detected by using a periodontal probe
Changes Clinical attachment level	baseline, 6 and 12 months	Distance from the implant shoulder or prosthetic abutment to the bottom of the peri-implant pocket.
Change Reccesion	baseline, 6 and 12 months	distance from the margin of the peri-implant mucosa to the implant / abutment interface.
Changes Probing pocket depth	baseline, 6 and 12 months	distance from the margin gingival to the bottom of the peri-implant pouch. All clinical variables will be recorded with a Hu-friedy CP15 UNC millimeter probe in six points on each implant.
Change supuration	baseline, 6 and 12 months	Pus presence register by scale binary (1 present / 0 absent)
configuration of the bone defect	baseline	Based on the classification of Schwarz et al. (2007)

Trial Locations

Locations (1)

Master Periodoncia. Facultad odontología; 🇪🇸 Santiago De Compostela, A Coruña, Spain