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Clinical Trials/NCT05201443
NCT05201443
Unknown
Not Applicable

Clinical and Biochemical Evaluation of the Efficacy of Non-Surgical Treatment Approaches in the Treatment of Peri-implantitis

Hacettepe University1 site in 1 country46 target enrollmentNovember 12, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Peri-Implantitis
Sponsor
Hacettepe University
Enrollment
46
Locations
1
Primary Endpoint
Clinical parameter probing depth
Last Updated
4 years ago

Overview

Brief Summary

Peri-implantitis is a pathological condition associated with plaque that develops around dental implants, characterized by inflammation and progressive bone loss in the peri-implant area. Bleeding on probing, suppuration, increased pathological pocket depths and/or mucosal recessions are seen with radiographic bone loss in peri-implantitis. When evaluated histologically, the lesion extends to the apical part of the pocket epithelium and contains a large amount of plasma cells, macrophages and neutrophils. In the Peri-implant crevicular fluid analysis, which is one of the most important parameters that enable the biochemical and immunological evaluation of the inflammatory state in the peri-implant region, information about the current inflammatory situation can be obtained by evaluating the content of an osmotic inflammatory exudate originating from the vessels in the gingival plexus. Many surgical and non-surgical methods have been proposed for the treatment of peri-implantitis. Mechanical surface debridement, laser application and air abrasives are a part of non-surgical treatment of peri-implantitis. In this study, we examined the effectiveness of diode laser in addition to mechanical debridement with titanium curettes. In our study, we aimed to compare these two treatments biochemically by determining the changes in interleukin-1β, Interleukin-10, Interleukin-17, RANKL, osteoprotegerin, TWEAK and sclerostin biomarkers in Peri-implant crevicular fluid and clinically.

Detailed Description

Primary outcome measures (probing depth as clinical parameter) and secondary outcome measures ( collection of gingival crevicular fluid, gingival bleeding time index, gingival index, plaque index and clinical attachment level) asre recorded in baseline, third and sixth month. The change between these parameters is observed.

Registry
clinicaltrials.gov
Start Date
November 12, 2018
End Date
October 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nazan Ece Erduran

Research Assistant

Hacettepe University

Eligibility Criteria

Inclusion Criteria

  • Presence of 5mm or more peri-implant pockets
  • Not having periodontal treatment in the last 3 months,
  • The informed consent form must be approved,
  • At least 18 years old.

Exclusion Criteria

  • Presence of systemic disease,
  • Regular use of non-steroidal anti inflammatory drugs,
  • Having been treated with antibiotics in the last 3 months,
  • Individuals in need of pre-treatment antibiotic prophylaxis,
  • Pregnancy and lactation,
  • Not approving the informed consent form,
  • Patients with known allergies.

Outcomes

Primary Outcomes

Clinical parameter probing depth

Time Frame: Baseline, 3 months and 6 months

The primary outcome of the study was the control examination performed 3 months after the first examination. Probing depth was measured with a periodontal probe by the distance between gingival margin and the base of the pocket. The change between these time frames are recorded.

Secondary Outcomes

  • Another outcome of the study is the collection of gingival crevicular fluid samples in the 3rd month.(Baseline, 3 months and 6 months)
  • Gingival bleeding time index(Baseline, 3 months and 6 months)
  • Gingival index(Baseline, 3 months and 6 months)
  • Plaque index(Baseline, 3 months and 6 months)
  • Clinical attachment level(Baseline, 3 months and 6 months)

Study Sites (1)

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