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NCT Number: NCT06730568

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gazi University Dentistry Faculty

Ankara, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • the presence of at least one titanium implant with clinical and radiographic signs of initial to moderate peri-implantitis
  • single-unit or partial restorations without overhangings
  • absence of occlusal overload
  • the presence of at least 2 mm of keratinized attached peri-implant mucosa
  • periodontally healthy participants with a good level of oral hygiene

Exclusion criteria

  • the presence of implant mobility
  • systemic diseases (i.e. diabetes (HbA1c <7), osteoporosis, bisphosphonate medication) which could affect the outcome of treatment
  • smoking
  • placement, and prosthetic loading of implants within the past year

Treatment and study plan

Submarginal mechanical instrumentation

Procedure

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.

Submarginal mechanical instrumentation and chlorhexidine irrigation

Procedure

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.

Submarginal mechanical instrumentation and ozone application

Procedure

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.

Submarginal mechanical instrumentation and air abrasion

Procedure

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.

Air abrasion monotherapy

Procedure

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. .

Primary outcomes

  1. Probable Pocket Depth

    Time frame: Baseline, 3 months, and 6 months after treatment

Secondary outcomes

  1. Bleeding on Probing

    Time frame: Baseline, 3 months, and 6 months after treatment

  2. Plaque Index

    Time frame: Baseline, 3 months, and 6 months after treatment

Sponsors and collaborators

Lead sponsor

Yeditepe University

Other

Collaborators

  • Gazi University

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 12, 2024
Registry last updated
Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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