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Clinical Trials/NCT06730568
NCT06730568
Completed
Not Applicable

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

Yeditepe University1 site in 1 country26 target enrollmentNovember 27, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Peri-implant Inflammation
Sponsor
Yeditepe University
Enrollment
26
Locations
1
Primary Endpoint
Probable Pocket Depth
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 27, 2017
End Date
June 4, 2018
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nihal ERAYDIN

Assistant Professor

Yeditepe University

Eligibility Criteria

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
  • placement, and prosthetic loading of implants within the past year

Outcomes

Primary Outcomes

Probable Pocket Depth

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

Secondary Outcomes

  • Bleeding on Probing(Baseline, 3 months, and 6 months after treatment)
  • Plaque Index(Baseline, 3 months, and 6 months after treatment)

Study Sites (1)

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