Clinical trial NCT05201443: Clinical and Biochemical Evaluation of the Efficacy of Non-Surgical Treatment Approaches in the Treatment of Peri-implantitis
Official title: Clinical and Biochemical Evaluation of the Efficacy of Non-Surgical Treatment Approaches in the Treatment of Peri-implantitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peri-Implantitis
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2022-01-21
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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,
* 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.

Primary outcomes:
measure: Clinical parameter probing depth
timeFrame: Baseline, 3 months and 6 months
Secondary outcomes:
measure: Another outcome of the study is the collection of gingival crevicular fluid samples in the 3rd month.
timeFrame: Baseline, 3 months and 6 months
measure: Gingival bleeding time index
timeFrame: Baseline, 3 months and 6 months
measure: Gingival index
timeFrame: Baseline, 3 months and 6 months
measure: Plaque index
timeFrame: Baseline, 3 months and 6 months
measure: Clinical attachment level
timeFrame: Baseline, 3 months and 6 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: study director
name: Güliz Nigar GÜNCÜ, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: Principal Investigator
name: Abdullah Cevdet AKMAN, Prof Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Principal Investigator
name: Rahime Meral NOHUTCU
role: PRINCIPAL_INVESTIGATOR
affiliation: Principal Investigator
name: Ali Tuğrul GÜR, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: biochemistry
name: Aslı PINAR, Prof Dr
role: PRINCIPAL_INVESTIGATOR
References: