NCT07750171

Brief Summary

Peri-implant diseases are inflammatory conditions affecting the gums and bone around dental implants. Peri-implant mucositis causes inflammation in the gums, while peri-implantitis can also lead to bone loss and, in severe cases, implant failure. Smoking is an important risk factor for these conditions because it may change how the immune system responds to inflammation and infection. This study will compare smokers and non-smokers with healthy dental implants, peri-implant mucositis, or peri-implantitis. Fluid samples will be collected from around the implants to measure proteins involved in inflammation, healing, and immune responses. The aim is to better understand how smoking affects the body's response to peri-implant diseases and to identify biological markers that may help assess disease risk and severity in the future.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
216

participants targeted

Target at P75+ for all trials

Timeline
4mo left

Started Jun 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress37%
Jun 2026Dec 2026

Study Start

First participant enrolled

June 1, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 6, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

August 6, 2026

Status Verified

August 1, 2026

Enrollment Period

4 months

First QC Date

August 3, 2026

Last Update Submit

August 3, 2026

Conditions

Keywords

Peri-implantitisHost immune responseSmoking

Outcome Measures

Primary Outcomes (1)

  • Peri-implant crevicular fluid levels of Th1/Th2-, M1/M2-, and B-cell-related immune markers

    Peri-implant crevicular fluid samples will be analyzed to determine the levels of IFN-γ, IL-12p70, IL-4, IL-13, IL-10, BAFF, and APRIL. These marker levels will be compared among smokers and non-smokers with peri-implant health, peri-implant mucositis, or peri-implantitis

    At a single study visit

Study Arms (6)

Non-Smokers With Peri-Implant Health

Participants who do not smoke and have clinically healthy peri-implant tissues.

Non-Smokers With Peri-Implant Mucositis

Participants who do not smoke and have peri-implant mucositis.

Non-Smokers With Peri-Implantitis

Participants who do not smoke and have peri-implantitis.

Smokers With Peri-Implant Health

Participants who smoke and have clinically healthy peri-implant tissues.

Smokers With Peri-Implant Mucositis

Participants who smoke and have peri-implant mucositis.

Smokers With Peri-Implantitis

Participants who smoke and have peri-implantitis

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will consist of adults with at least one dental implant who attend the Department of Periodontology at Gazi University Faculty of Dentistry. Eligible participants will be classified as smokers or non-smokers and further assigned to one of three groups according to their peri-implant condition: peri-implant health, peri-implant mucositis, or peri-implantitis. Participants will be consecutively recruited until the target sample size is reached.

You may qualify if:

  • willingness to participate in the study;
  • having at least one dental implant that has been in function for at least one year;
  • having an implant diagnosed with peri-implant health, peri-implant mucositis, or initial peri-implantitis according to the study definitions; for the initial peri-implantitis group, having an implant with PD of 6-7 mm.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University

Ankara, Ankara, 06510, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Peri-ImplantitisSmoking

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesBehavior

Study Officials

  • Buse Naz Büyükakçalı, DDS

    Gazi University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Buse Naz Büyükakçalı, DDS

CONTACT

Aysen Bodur, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

August 3, 2026

First Posted

August 6, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

August 6, 2026

Record last verified: 2026-08

Locations