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

H

Hacettepe University

Status

Unknown

Conditions

Peri-Implantitis

Treatments

Device: Diode laser
Device: Titanium curettes

Study type

Interventional

Funder types

Other

Identifiers

NCT05201443
KA-19059

Details and patient eligibility

About

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.

Full 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.

Enrollment

46 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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,
  • Smoking,
  • 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

46 participants in 2 patient groups

Diode Laser
Experimental group
Description:
At baseline, diode laser is applied to one group.
Treatment:
Device: Diode laser
Device: Titanium curettes
Titanium curettes
Active Comparator group
Description:
At baseline, titanium curettes are used to both of the groups
Treatment:
Device: Titanium curettes

Trial contacts and locations

1

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Central trial contact

Nazan Ece ERDURAN; Güliz Nigar Güncü

Data sourced from clinicaltrials.gov

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