NCT06730568

Effect of Different Non-surgical Treatment Approaches of Peri-implantitis

Effect of Different Non-surgical Treatment Approaches of Peri-implantitis: a Multi-arm Randomized Controlled Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Yeditepe University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Peri-implantitis is a biofilm-associated pathological condition characterized by inflammation within the peri-implant mucosa, which leads to the progressive loss of the surrounding supporting bone tissue. The primary goal of managing peri-implantitis is to control the peri-implant biofilm and resolve inflammation. Nonsurgical treatment of peri-implantitis by submarginal mechanical instrumentation alone typically provides clinical improvements, particularly in non-advanced cases. However, to ensure surface decontamination and enhance treatment outcomes, alternative or adjunctive methods, such as systemic/local antibiotics, antiseptics, lasers, and air-abrasion systems, have been proposed. Therefore, the null hypothesis (H0) of the present study is that no statistically significant difference would be detected in clinical inflammation signs among patients diagnosed with early-stage peri-implantitis after undergoing one of the following treatments: nonsurgical mechanical instrumentation alone, mechanical instrumentation plus chlorhexidine (CHX), mechanical instrumentation plus gaseous ozone, mechanical instrumentation plus glycine air polishing, or glycine air polishing alone.

Conditions

• Peri-implant Inflammation
• Peri-Implantitis and Peri-implant Mucositis
• Non-surgical Treatment

Interventions

Type	Name	Description
PROCEDURE	Submarginal mechanical instrumentation	Local anesthesia was applied before the procedure. The operator performed submarginal mechanical debridement until the implant surface was deemed adequately cleaned. No adjunctive therapies were applied in this group.
PROCEDURE	Submarginal mechanical instrumentation and chlorhexidine irrigation	The participants in the mechanical instrumentation with chlorhexidine (MC) group were treated with conventional submarginal instrumentation using titanium curettes. Local anesthesia was applied before the procedure. The operator performed submarginal mechanical debridement until the implant surface was deemed adequately cleaned. Following mechanical instrumentation, the peri-implant pockets were irrigated with 0.2% chlorhexidine digluconate solution for 1 minute.
PROCEDURE	Submarginal mechanical instrumentation and ozone application	The participants in the mechanical instrumentation with ozone (MO) group were treated with conventional submarginal instrumentation using titanium curettes. Local anesthesia was applied before the procedure. The operator performed submarginal mechanical debridement until the implant surface was deemed adequately cleaned. Following mechanical instrumentation, gaseous ozone was applied to the peri-implant pockets using an ozone-generating device and a specialized glass fiber probe. The ozone gas was delivered to four sites (mesial, distal, buccal, and lingual) for 15 seconds per site, resulting in a total application time of 1 minute per implant. The device operated at a power of 3 watts and 80% oxygen concentration, as recommended by the manufacturer.
PROCEDURE	Submarginal mechanical instrumentation and air abrasion	The participants in the mechanical instrumentation with glycine powder air abrasion (MA) group were treated with conventional submarginal instrumentation using titanium curettes. Local anesthesia was applied before the procedure. The operator performed submarginal mechanical debridement until the implant surface was deemed adequately cleaned. Following mechanical instrumentation, the peri-implant pockets were treated with glycine powder-based air abrasion using an air-abrasion device (AIR-FLOW® handy 3.0 PERIO HANDPIECE, EMS, Nyon, Switzerland) and a flexible Perio-Flow® nozzle. The nozzle was inserted into the pockets and guided in a circular motion from coronal to apical, parallel to the implant surface, in a non-contact mode as recommended by the manufacturer. The air-abrasion treatment was applied to four sites (mesial, distal, buccal, and lingual) for 5 seconds per site, resulting in a total application time of 20 seconds per implant.
PROCEDURE	Air abrasion monotherapy	The participants in the glycine powder air abrasion monotherapy (A) group were treated exclusively with glycine powder-based air abrasion. Local anesthesia was applied before the procedure. The peri-implant pockets were instrumented with an air-abrasion device using glycine powder and a flexible nozzle. The nozzle was inserted into the pockets and guided in a circular motion from coronal to apical, parallel to the implant surface, in a non-contact mode as recommended by the manufacturer. The air-abrasion treatment was applied to four sites (mesial, distal, buccal, and lingual) for 5 seconds per site, resulting in a total application time of 20 seconds per implant. .

Timeline

• Start date: 2017-11-27
• Primary completion: 2018-02-27
• Completion: 2018-06-04
• First posted: 2024-12-12
• Last updated: 2024-12-12

Locations

1 site across 1 country: Turkey (Türkiye)