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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05201443
Enrollment
46
Registered
2022-01-21
Start date
2018-11-12
Completion date
2022-10-31
Last updated
2022-03-02

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

Conditions

Peri-Implantitis

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.

Interventions

DEVICEDiode laser

Diode Laser is applied to one group as an adjunctive therapy.

Non-surgical treatment with titanium curettes were administrated to both groups.

Sponsors

Hacettepe University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

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

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.

Design outcomes

Primary

MeasureTime frameDescription
Clinical parameter probing depthBaseline, 3 months and 6 monthsThe 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

MeasureTime frameDescription
Another outcome of the study is the collection of gingival crevicular fluid samples in the 3rd month.Baseline, 3 months and 6 monthsSamples are obtained by means of paper strips placed gently in the gingival groove. These samples are stored at -20 ° C for later analysis by ELISA method. The change between these time frames are recorded.
Gingival bleeding time indexBaseline, 3 months and 6 monthsBleeding on probing according to the time is recorded. The change between these time frames are recorded.
Gingival indexBaseline, 3 months and 6 monthsThe gingival index is graded as follows: 0 = Normal gingiva 1. Mild inflammation, slight change in color, slight oedema. No bleeding on probing 2. Moderate inflammation redness, oedema and glazing. Bleeding on probing 3. Severe inflammation marked redness and oedema. Ulceration. Tendency to spontaneous bleeding.
Clinical attachment levelBaseline, 3 months and 6 monthsThe distance in millimeters from the cemento-enamel junction to the bottom of the pocket.
Plaque indexBaseline, 3 months and 6 months0 = No plaque in the gingival area. 1. A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may only be recognized by running a probe across the tooth surface. 2. Moderate accumulation of soft deposits within the gingival pocket, on the gingival margin and/or adjacent tooth surface, which can be seen by the naked eye. 3. Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface.

Countries

Turkey (Türkiye)

Contacts

Primary ContactNazan Ece ERDURAN
nazaneceerduran@gmail.com00905541900462
Backup ContactGüliz Nigar Güncü
gngun1@gmail.com

Outcome results

None listed

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