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Clinical Trials/NCT05823038
NCT05823038
Completed
Not Applicable

Evaluation of Implant Patients by Peri-implant Disease Risk Analysis and Aesthetic Score

Abant Izzet Baysal University1 site in 1 country298 target enrollmentJuly 4, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Implant Assesment
Sponsor
Abant Izzet Baysal University
Enrollment
298
Locations
1
Primary Endpoint
Implant disease risk assesment
Status
Completed
Last Updated
last year

Overview

Brief Summary

This study examines the peri-implant risk assessment diagram and the aesthetic, peri-implant health status, and gingival level around the implant in patients with implants by comparing them in smokers and non-smokers.

: After completion of the examination, 298 dental implants for at least three months after functional prosthesis loading, except for patients with bruxism and uncontrolled diabetes, were included in the study. Patients are primarily divided into smokers and non-smokers. In all implant patients, plaque, gingival index, bleeding on probing, pocket depth, clinical attachment loss, gingival recession, keratinized thickness, keratinized width, vestibule depth, pink aesthetic score, and peri-implant disease risk analysis are evaluated in sequence.

Registry
clinicaltrials.gov
Start Date
July 4, 2022
End Date
January 5, 2023
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Tuğba ŞAHİN

Assistant professor

Abant Izzet Baysal University

Eligibility Criteria

Inclusion Criteria

  • 18-70 years old patients
  • Patients who are systemically healthy and have a controlled medical condition
  • Patients with fixed prosthesis on the implant at least 6 months after the functional prosthetic loading of the dental implant

Exclusion Criteria

  • Patients with uncontrolled systemic diseases
  • Those who have the habit of bruxism

Outcomes

Primary Outcomes

Implant disease risk assesment

Time Frame: baseline

The IDRA algorithm is a promising tool to assess patients at moderate or high risk of developing peri-implantitis. The eight vectors of the diagram include: an assessment of a history of periodontitis, the percentage of sites with bleeding on probing (BOP), the number of teeth/implants with probing depths (PD) ≥5 mm, the ratio of periodontal bone loss (evaluated from a radiograph) divided by the patient's age, periodontitis susceptibility as described by the staging and grading categories from the 2017 World Workshop on the Classification of Periodontal and Peri-implant Diseases , the frequency/compliance with supportive periodontal therapy, the distance from the restorative margin of the implant-supported prosthesis to the marginal bone crest, and prosthesis related factors including cleanability and fit of the implant-supported prosthesis.

Pink esthetic scale

Time Frame: baseline

With the pink aesthetic score, the post-implant process is scored according to the papilla, tissue contours, gingival level, alveolar process, color, and tissue condition. The thresholds for clinical acceptance, which was currently set at values of 8/14 for the PES. The thresholds for clinical acceptance are currently set at values of 8 to 14 for the PES.

Dental implant health scale

Time Frame: baseline

The Implant Quality of The Health Scale allows the dentist to evaluate an implant using the listed criteria, place it in the appropriate category of health or disease, and then treat the implant accordingly. Three primary classes were established by the Consensus: success, survival, and failure. The success category describes optimum conditions, the survival category describes implants still in function but not with ideal conditions, and the loss of an implant represents an the implant that should be or already has been removed. Implant Quality Scale Group Clinical Conditions 1. Success (optimum health) a) No pain or tenderness upon function b) 0 mobility c) \<2 mm radiographic bone loss from initial surgery d) No exudates history 2. Satisfactory survival a) No pain on function b) 0 mobility c) 2-4 mm radiographic bone loss d) No exudates history 3. Compromised survival a) May have sensitivity on function b) No mobility c) Radiographic bone loss\> 4 mm(less than ½ of implant

Keratinized tissue thickness

Time Frame: baseline

It is advanced to the bone with a canal file. The distance between the stopper and the tip of the file is measured.

Keratinized tissue width

Time Frame: baseline

Keratinized mucosa width was defined as the distance between the gingival margin and mucogingival junction at the mid-buccal area

Periodontal depth

Time Frame: baseline

Measuring the distance from the gingival margin to the mucogingival line with a periodontal probe.

Vestibular depth

Time Frame: baseline

Vestibular depth is measured either from crest of lip or from coronal border of the attached gingiva to depth of mucobuccal fold.

Bleeding on probing

Time Frame: baseline

To determine the bleeding index on probing, the pocket floor, and the inflammatory state of the pocket epithelium, an evaluation is made according to whether there is bleeding in the sulcus 30 seconds after the pocket depth measurement from 6 regions of all the teeth of the patients: mesiobuccal, mid-buccal, distobuccal, mesiolingual, mid-lingual and distolingual.

Secondary Outcomes

  • Clinical attachment level(baseline)
  • Plaque index(baseline)
  • Gingival index(baseline)
  • Gingival recession(baseline)

Study Sites (1)

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