Evaluation of Fractalkine and Its Receptor in Peri-implantitis

November 11, 2024 updated by: Kubilay BARIŞ

Evaluation of Fractalkine and Its Receptor in the Non-Surgical Treatment of Peri-implantitis

In this study, mechanical debridement group, Er:YAG laser group and diode laser group will be compared in terms of reducing peri-implant sulcus depth in the treatment of peri-implantitis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Kırıkkale, Turkey, 71000
        • Recruiting
        • Kırıkkale University, Faculty of Dentistry, Department of Periodontology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Probing depth of 4-6 mm, bone loss of at least 2 mm on X-ray and presence of inflammatory symptoms in soft tissue
  • No systemic disease that may affect the outcome of the treatment
  • Patients with healthy periodontium or patients with completed periodontal treatment
  • Individuals at least 6 months after prosthesis loading on the implant
  • Individuals who do not require further surgery for the treatment of peri-implantitis
  • Implants with at least 2 mm keratised gingiva
  • Individuals aged 40-60 years

Exclusion Criteria:

  • Individuals undergoing radiation therapy
  • Individuals who smoke and drink alcohol
  • Individuals in pregnancy or lactation
  • Individuals who have received antibiotic treatment in the last three months
  • Individuals with parafunctional habits

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Group healty
Experimental: Mechanical debridement group
Procedure: Subgingival debridement
To be applied 1 times (0. days)
Experimental: Er:YAG laser applied group
Procedure: Er:YAG laser decontamination
To be applied 3 times
Experimental: Diyot laser applied group
Procedure: Diyot laser decontamination
To be applied 3 times

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Probing depth, clinical attachment loss
Time Frame: sixth month
Measurement will be made with a periodontal probe. The unit of measurement is millimetre. The primary outcome measures are interrelated.
sixth month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
gingival index, plaque index, sulcus blood index
Time Frame: sixth month
The 0,1,2,3 point system for index measurements is currently used in periodontology. These scores will be used in secondary outcome measures.
sixth month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kubilay BARIŞ

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 8, 2024

Primary Completion (Estimated)

May 8, 2025

Study Completion (Estimated)

May 15, 2025

Study Registration Dates

First Submitted

November 8, 2024

First Submitted That Met QC Criteria

November 11, 2024

First Posted (Estimated)

November 12, 2024

Study Record Updates

Last Update Posted (Estimated)

November 12, 2024

Last Update Submitted That Met QC Criteria

November 11, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KU-DHF-KB-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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