Risk and Aesthetic Assesment in Implant Patient

Completed

• Conditions: Implant Assesment

• Registration Number: NCT05823038
• Lead Sponsor: Abant Izzet Baysal University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-04
• Primary Completion: 2023-01-05
• Study Completion: 2023-01-05
• Study First Submitted: 2023-04-08
• Study First Submitted QC: 2023-04-08
• Study First Posted: 2023-04-21
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-02
• Last Update Posted: 2025-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 298

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Implant disease risk assesment	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	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	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	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	baseline	Keratinized mucosa width was defined as the distance between the gingival margin and mucogingival junction at the mid-buccal area
Periodontal depth	baseline	Measuring the distance from the gingival margin to the mucogingival line with a periodontal probe.
Bleeding on probing	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.
Vestibular depth	baseline	Vestibular depth is measured either from crest of lip or from coronal border of the attached gingiva to depth of mucobuccal fold.

Secondary Outcome Measures

Name	Time	Method
Gingival recession	baseline	Gingival recession is the exposure of the root surface resulting from migration of the gingival margin apical to the cementoenamel junction.
Clinical attachment level	baseline	Clinical attachment level/loss measured in mm as distance from the CEJ to the gingival margin.
Plaque index	baseline	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.
Gingival index	baseline	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.

Trial Locations

Locations (1)

Bolu Abant İzzet Baysal University; 🇹🇷 Bolu, Turkey