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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06128850
Other study ID # 2022/163
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 4, 2022
Est. completion date March 31, 2023

Study information

Verified date November 2023
Source Abant Izzet Baysal University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 143
Est. completion date March 31, 2023
Est. primary completion date July 4, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Exclusion Criteria: - Bruxism - Uncontrolled medical conditions

Study Design


Intervention

Other:
disease
compare to diseases

Locations

Country Name City State
Turkey Bolu Abant Izzet Baysal University Bolu

Sponsors (1)

Lead Sponsor Collaborator
Abant Izzet Baysal University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Plaque index The plaque index assesses the amount of dental plaque visible on the vestibular and lingual surfaces of all teeth Baseline
Primary Gingival index This measurement is based on the presence or absence of bleeding on gentle probing Baseline
Primary 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 Periodontal pocket depth a pathologically deepened gingival sulcus around a tooth at the gingival margin. Baseline
Secondary Clinical attachment level CAL is calculated by subtracting the gingival margin level from the probing depth. Baseline
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