NCT04440241

Regenerative Surgical Treatment of Peri-implant Defects

Regenerative Surgical Treatment of Peri-implant Defects. Submerged Versus Not Submerged

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: University of Santiago de Compostela · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Implant Site Pocket Infection

Interventions

Type	Name	Description
PROCEDURE	regenerative treatment periimplantitis	Full thickness buccal and lingual flaps will be performed. After debridement of the defect using hand and ultrasonic instruments and implant surface decontamination using titanium brushes (TiBrush®) and saline Regenerative treatment will be performed only in the intrabony component of type 1 peri-implant defects. Guided bone regeneration using a bone substitute (Bio-oss®) and a resorbable membrane (bio-gide®) will be performed in the intrabony and dehiscenses areas of the defect. The surgeon will be blinded to the assignment of treatment until it is time to close the flaps.

Timeline

• Start date: 2021-04-01
• Primary completion: 2021-12-01
• Completion: 2022-12-01
• First posted: 2020-06-19
• Last updated: 2021-09-29

Locations

1 site across 1 country: Spain