Risk and Aesthetic Assesment in Implant Patient (EIPPDRAAS)

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

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.

Study Overview

• Status: Completed
• Conditions: Implant Assesment

• Study Type: Observational
• Enrollment (Actual): 298

Contacts and Locations

Study Locations

• Turkey
  • Bolu, Turkey
    • Bolu abant Izzet Baysal University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

298 dental implants for at least 6 months after functional prosthetic loading were included in the study. Patients are primarily divided into smokers and non-smokers.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Keratinized tissue thickness	It is advanced to the bone with a canal file. The distance between the stopper and the tip of the file is measured.	baseline
Keratinized tissue width	Keratinized mucosa width was defined as the distance between the gingival margin and mucogingival junction at the mid-buccal area	baseline
Periodontal depth	Measuring the distance from the gingival margin to the mucogingival line with a periodontal probe.	baseline
Bleeding on probing	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.	baseline
Vestibular depth	Vestibular depth is measured either from crest of lip or from coronal border of the attached gingiva to depth of mucobuccal fold.	baseline
Implant disease risk assesment	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.	baseline
Pink esthetic scale	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.	baseline
Dental implant health scale	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; 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; Satisfactory survival a) No pain on function b) 0 mobility c) 2-4 mm radiographic bone loss d) No exudates history; Compromised survival a) May have sensitivity on function b) No mobility c) Radiographic bone loss> 4 mm(less than ½ of implant	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plaque index	In the plaque index, the mesiobuccal, mid-buccal, distobuccal, mesiolingual, mid-lingual, and distolingual regions of the implant or implants and dental plaque thickness to the gingiva are evaluated by probing.	baseline
Gingival index	The gingival index evaluates bleeding, the most basic sign of inflammation. The implants' mesiobuccal, mid-buccal, distobuccal, mesiolingual, mid-lingual, and distolingual surfaces are measured.	baseline
Clinical attachment level	Clinical attachment level/loss measured in mm as distance from the CEJ to the gingival margin.	baseline
Gingival recession	Gingival recession is the exposure of the root surface resulting from migration of the gingival margin apical to the cementoenamel junction.	baseline

Collaborators and Investigators

• Sponsor: Abant Izzet Baysal University
• Investigators: Principal Investigator: Ramazan Kurul, Ass. Prof, Abant Izzet Baysal University

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2022
• Primary Completion (Actual): January 5, 2023
• Study Completion (Actual): January 5, 2023

Study Registration Dates

• First Submitted: April 8, 2023
• First Submitted That Met QC Criteria: April 8, 2023
• First Posted (Actual): April 21, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 2, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Periodontal disease; Periodontal health; Implant disease risk assesment; Pink esthetic score; Implant quality scale
• Other Study ID Numbers: 2022/160

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No