NCT06810401

Brief Summary

Peri-implantitis is a condition affecting tissues around dental implants, leading to inflammation and bone loss. Smoking is a known risk factor that increases the risk of developing peri-implantitis and reduces treatment success. Smokers often have worse outcomes after treatment compared to non-smokers. Macrophage activity is crucial for fighting infections, but smoking can impair their function, leading to tissue damage. Smoking reduces blood flow and oxygen levels in tissues, hindering healing. Specific chemokines (CCL-2, CCL-8, CXCL-9, and CCL-3) help direct immune responses by recruiting macrophages and other immune cells to infection sites. Understanding how smoking affects these chemokines is essential for improving peri-implantitis treatment outcomes. Peri-implantitis is a complex condition caused by various factors, which makes it challenging to study how smoking affects the immune response in advanced stages of the disease. This study aims to investigate how smoking influences specific chemical signals associated with the immune response (CCL-2, CCL-8, CCL-3, and CXCL-9) in the fluid around dental implants, both before and after non-surgical treatment. The research will compare smokers to non-smokers during the early stages of peri-implantitis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 28, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 14, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 14, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 5, 2025

Completed
Last Updated

February 5, 2025

Status Verified

January 1, 2025

Enrollment Period

6 months

First QC Date

January 22, 2025

Last Update Submit

January 31, 2025

Conditions

Keywords

Peri-implantitisSmokingChemokines

Outcome Measures

Primary Outcomes (1)

  • Biochemical Outcomes

    Analysis and comparison of peri-implant crevicular fluid levels of CCL-2, CCL-3, and CXCL-9 before and after non-surgical treatment of initial peri-implantitis in smokers and non-smokers.

    Assessment and comparison of peri-implant crevicular fluid chemokine levels before and four months after non-surgical treatment of initial peri-implantitis in smoking and non-smoking individuals

Secondary Outcomes (3)

  • Probing Pocket Depth (mm)

    Assessment and comparison of clinical outcomes for non-surgical treatment of peri-implantitis before and after four months.

  • Bleeding on Probing

    Assessment and comparison of clinical outcomes for non-surgical treatment of peri-implantitis before and after four months.

  • Visible Plaque Score

    Assessment and comparison of clinical outcomes for non-surgical treatment of peri-implantitis before and after four months.

Study Arms (1)

Peri-implantitis patients

EXPERIMENTAL

All peri-implantitis patients in both smoking and non-smoking groups received full-mouth non-surgical periodontal treatment using sterile ultrasonic scalers (Woodpecker Piezo Cavitron Ultrasonic Scaler Handpiece (HW-5L), EMS, Switzerland)), currets (Lsh6-h7, Osung MND, Korea), and sterile saline irrigations. Non-surgical treatment of peri-implantitis involves the debridement of hard- and soft accumulations on implant surfaces using titanium curettes (Titanium Implant Scaler 204SD, Hu-Friedy) for 15 minutes, followed by irrigation with sterile saline solution

Procedure: Debridement of implant surface with titanium curettes and irrigation with sterile saline solution

Interventions

All patients in both groups received non-surgical treatment of peri-implantitis involving the debridement of hard- and soft accumulations on implant surfaces using titanium curettes (Titanium Implant Scaler 204SD, Hu-Friedy) for 15 minutes, followed by irrigation with sterile saline solution

Also known as: Non-surgical treatment of peri-implantitis
Peri-implantitis patients

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • willingness to participate in the study
  • having a dental implant that was loaded at least one year before the initiation of the study, that was diagnosed with peri-implantitis, and that has PD of 6-7 mm, 3) the implants had been in function for at least 1 year.

You may not qualify if:

  • having received periodontal therapy or any oral decontamination treatment or received antibiotics or steroids in the last six months before the initiation of the study,
  • being pregnant or breastfeeding,
  • being diagnosed with rheumatoid arthritis, lupus erythematosus, poorly controlled systemic diseases (such as diabetes or hypertension),
  • having a medical history of radiation or cancer therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University

Ankara, Çankaya, 06490, Turkey (Türkiye)

Location

Related Publications (1)

  • Altay BNB, Cankaya ZT, Yilmaz M, Gursoy M, Bodur A, Gursoy UK. Impact of Smoking on Macrophage-Related Chemokines During Initial Peri-Implantitis: A Prospective Cohort Study. Clin Implant Dent Relat Res. 2025 Jun;27(3):e70052. doi: 10.1111/cid.70052.

MeSH Terms

Conditions

Peri-ImplantitisSmoking

Interventions

Therapeutic Irrigation

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesBehavior

Intervention Hierarchy (Ancestors)

HydrotherapyPhysical Therapy ModalitiesTherapeuticsRehabilitationInvestigative Techniques

Study Officials

  • Ulvi K GURSOY, Prof.

    University of Turku

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator, Research Assistant

Study Record Dates

First Submitted

January 22, 2025

First Posted

February 5, 2025

Study Start

April 28, 2024

Primary Completion

October 14, 2024

Study Completion

October 14, 2024

Last Updated

February 5, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations