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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06730568
Enrollment
26
Registered
2024-12-12
Start date
2017-11-27
Completion date
2018-06-04
Last updated
2024-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief 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.

Interventions

PROCEDURESubmarginal 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.

PROCEDURESubmarginal 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.

PROCEDURESubmarginal 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.

PROCEDURESubmarginal 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.

PROCEDUREAir 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. .

Sponsors

Gazi University
CollaboratorOTHER
Yeditepe University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Probable Pocket DepthBaseline, 3 months, and 6 months after treatment

Secondary

MeasureTime frame
Bleeding on ProbingBaseline, 3 months, and 6 months after treatment
Plaque IndexBaseline, 3 months, and 6 months after treatment

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026