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

NCT ID: NCT05201443

Last Updated: 2022-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-12

Study Completion Date

2022-10-31

Brief Summary

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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

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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.

Conditions

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Peri-Implantitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Diode Laser

At baseline, diode laser is applied to one group.

Group Type EXPERIMENTAL

Diode laser

Intervention Type DEVICE

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

Titanium curettes

Intervention Type DEVICE

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

Titanium curettes

At baseline, titanium curettes are used to both of the groups

Group Type ACTIVE_COMPARATOR

Titanium curettes

Intervention Type DEVICE

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

Interventions

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Diode laser

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

Intervention Type DEVICE

Titanium curettes

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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Nazan Ece Erduran

Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Güliz Nigar GÜNCÜ, Prof. Dr.

Role: STUDY_DIRECTOR

study director

Abdullah Cevdet AKMAN, Prof Dr

Role: PRINCIPAL_INVESTIGATOR

Principal Investigator

Rahime Meral NOHUTCU

Role: PRINCIPAL_INVESTIGATOR

Principal Investigator

Ali Tuğrul GÜR, Phd

Role: PRINCIPAL_INVESTIGATOR

Principal Investigator

Aslı PINAR, Prof Dr

Role: PRINCIPAL_INVESTIGATOR

biochemistry

Locations

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Hacettepe University

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Nazan Ece ERDURAN

Role: CONTACT

00905541900462

Güliz Nigar Güncü

Role: CONTACT

Facility Contacts

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Nazan Ece Erduran

Role: primary

Other Identifiers

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KA-19059

Identifier Type: -

Identifier Source: org_study_id

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