Risk and Aesthetic Assesment in Implant Patient

NCT05823038 | Completed

• 1 other identifier: 2022/160
• Study Type: observational
• Target: 298
• Locations: 1 country
• Sites: 1

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.

Conditions

Implant Assesment

Keywords

Implant disease risk assesment; Pink esthetic score; Implant quality scale; Periodontal health; Periodontal disease

Outcome Measures

Primary Outcomes (8)

• 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 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

  baseline

• 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

Secondary Outcomes (4)

• Plaque index

  baseline

• Gingival index

  baseline

• Clinical attachment level

  baseline

• Gingival recession

  baseline

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

Bolu Abant İzzet Baysal University

Bolu, Turkey, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Ramazan Kurul, Ass. Prof

  Abant Izzet Baysal University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: April 8, 2023
• First Posted: April 21, 2023
• Study Start: July 4, 2022
• Primary Completion: January 5, 2023
• Study Completion: January 5, 2023
• Last Updated: February 4, 2025

Record last verified: 2025-02

Locations

TU (1)