NCT06128850

Brief Summary

Except for patients with referred clinical bruxism and uncontrolled medical conditions, the study included 123 implants with implanted fixed prostheses that had lasted at least six months after functional prosthetic loading. In all implant patients, the health scale ranged from implants and natural teeth to plaque, gingival index, bleeding in the probe, mouth depth, loss of clinical attachment, and dental implants. The health and illness of the implants have been determined. Patients were divided into three groups: peri-implantitis, peri-implant mucositis, and peri-implant health. Inclusion Criteria:

  • Patients between the ages of 18- 70
  • Drugs that have a systemically healthy and controlled treatment situation
  • Drivers who have implant-supported fixed prostheses that have been at least six months after functional prosthetic loading Among these groups, it was checked whether periodontitis was seen in patients with peri-implantitis, gingivitis in patients with peri-implant mucositis, and whether healthy gums were seen in individuals with peri-implant health. To determine the health and disease status of individuals' implants, plaque index (Silness Loe 1964), gingival index (Loe Silness 1963), bleeding on probing (Ainoma Bay 1975), pocket depth measurements, and clinical attachment level were collected.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
143

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2022

Shorter than P25 for all trials

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

July 4, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 4, 2022

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 13, 2023

Completed
Last Updated

July 24, 2024

Status Verified

July 1, 2024

Enrollment Period

Same day

First QC Date

November 8, 2023

Last Update Submit

July 23, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Plaque index

    The plaque index assesses the amount of dental plaque visible on the vestibular and lingual surfaces of all teeth

    Baseline

  • Gingival index

    This measurement is based on the presence or absence of bleeding on gentle probing

    Baseline

  • Bleeding on probing

    Bleeding, leading sign of inflammation inside the connective tissue, is a critical factor for pocket depth measurements, and with other variable factors prevents making reproducible measurements.

    Baseline

Secondary Outcomes (2)

  • Periodontal pocket depth

    Baseline

  • Clinical attachment level

    Baseline

Study Arms (3)

Peri-implantitis

Other: disease

Peri-implant mucositis

Other: disease

Peri-implant health

Other: disease

Interventions

diseaseOTHER

compare to diseases

Peri-implant healthPeri-implant mucositisPeri-implantitis

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The health and illness of the implants have been determined. Patients were divided into three groups: peri-implantitis, peri-implant mucositis, and peri-implant health.

You may qualify if:

  • Patients between the ages of 18- 70
  • Drugs that have a systemically healthy and controlled treatment situation
  • Drivers who have implant-supported fixed prostheses that have been at least six months after functional prosthetic loading

You may not qualify if:

  • Bruxism
  • Uncontrolled medical conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bolu Abant İzzet Baysal University

Bolu, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Peri-ImplantitisPeriodontitisGingivitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesInfectionsGingival Diseases

Study Design

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

Study Record Dates

First Submitted

November 8, 2023

First Posted

November 13, 2023

Study Start

July 4, 2022

Primary Completion

July 4, 2022

Study Completion

March 31, 2023

Last Updated

July 24, 2024

Record last verified: 2024-07

Locations