NCT07564687

Brief Summary

Implant patients who applied to Bolu Abant İzzet Baysal University provided anamnesis. The study included 165 people with 272 implants. The study includes implants that satisfied the inclusion criteria. Plaque index (PI) \[13\], gingival index (GI) \[14\], bleeding on probing (BOP) \[15\], periodontal pocket depth (PPD), clinical attachment level (CAL), gingival recession (GR), GP, GT, and KTW were all assessed in every implant patient. The presence of peri-implant mucositis or peri-implant health was assessed using the collected indices and radiographs. The patients were split into two groups: those with peri-implant mucositis (136 implants) and those with peri-implant health (136 implants). We investigated the relationships between each parameter and periodontal health.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
272

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2024

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

June 11, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2026

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 4, 2026

Completed
Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

1.7 years

First QC Date

April 27, 2026

Last Update Submit

April 27, 2026

Conditions

Keywords

Dental ImplantsGingivaPeri-implant tissue

Outcome Measures

Primary Outcomes (1)

  • Gingival phenotype

    If the probe was visible when placed in the sulcus, gingiva was classified as thin (≤1 mm), and if the reflection of the probe was not visible, it was classified as thick (\> 1 mm).

    Baseline

Secondary Outcomes (8)

  • Periodontal pocket depth

    Baseline

  • Bleeding on probing

    Baseline

  • Plaque index

    Baseline

  • Gingival index

    Baseline

  • Clinical attachment level

    Baseline

  • +3 more secondary outcomes

Study Arms (2)

Peri-implant mucositis

In the absence of bone loss, peri-implant mucositis refers to inflammation of the mucosa surrounding endosseous tissue

Other: Implant

Periodontal health

Peri-implant health is characterized by the absence of erythema, bleeding on probing, swelling, and suppuration, and is synonymous with implant success

Other: Implant

Interventions

ImplantOTHER

The classification of peri-implant diseases is based on clinical and radiographic criteria, distinguishing between peri-implant mucositis and peri-implantitis according to the presence of inflammation and bone loss.

Peri-implant mucositisPeriodontal health

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have received implants

You may qualify if:

  • Patients aged 18-65 years who were systemically healthy, had a controlled medical conditions, and had fixed prostheses on the implants for at least 1 year following functional prosthetic loading of the dental implants.

You may not qualify if:

  • Individuals with bruxism; those who smoke, were pregnant, or were breastfeeding; those who used anti-inflammatory drugs, immunosuppressants, or medications affecting the mucosa and bone; those who had undergone peri-implant disease treatment after implant placement; and those with residual cement residue and peri-implantitis related to prosthesis design or incorrectly placed implants.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bolu Abant İzzet Baysal University

Bolu, Turkey, 14300, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Drug Implants

Intervention Hierarchy (Ancestors)

Delayed-Action PreparationsDosage FormsPharmaceutical Preparations

Study Officials

  • TUGBA SAHIN

    Abant Izzet Baysal University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

April 27, 2026

First Posted

May 4, 2026

Study Start

June 11, 2024

Primary Completion

March 2, 2026

Study Completion

March 3, 2026

Last Updated

May 4, 2026

Record last verified: 2026-04

Locations