NCT06148012

Brief Summary

Purpose: The aim of this study was to investigate the influence of surface characteristics and geometric design on marginal bone loss and bone quality in dental implants. Materials and Methods: A total of 378 implants from 114 patients were evaluated in this study using panoramic and periapical radiographs. Implants were categorized into 19 subgroups according to the jaw where they were placed, length, diameter, surface preparation, type of prosthetic superstructure, and neck design. Radiological evaluations were conducted based on radiographs obtained at the time of implant placement and 3 months after prosthetic loading. After obtaining measurements of marginal bone loss and fractal analysis data, the significance of differences between groups was statistically evaluated.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 28, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2024

Completed
Last Updated

January 28, 2025

Status Verified

November 1, 2023

Enrollment Period

3 months

First QC Date

November 13, 2023

Last Update Submit

January 24, 2025

Conditions

Keywords

dental implantmarginal bone lossperi-implantitisfractal analysis

Outcome Measures

Primary Outcomes (2)

  • Marginal Bone Loss around different dental implants

    Number of Participants: 114 Number of Dental Implants: 378 Implants will be categorized into 19 subgroups according to the jaw where they were placed, length, diameter, surface preparation, type of prosthetic superstructure, and neck design. Radiological evaluations will be conducted based on radiographs obtained at the time of implant placement and 3 months after prosthetic loading. The distance between the most coronal part of the implant neck and the most apical part of the defect caused by marginal bone loss(millimeters) will be measured. The magnification ratio will be calculated by comparing the previously recorded implant length with the length measured on the software, allowing the determination of the actual value of MBL.

    180 days

  • Fractal values around dental implant radiographs

    A total of 378 implants from 114 patients will be evaluated in this study using panoramic and periapical radiographs. Implants will be categorized into 19 subgroups according to the jaw where they were placed, length, diameter, surface preparation, type of prosthetic superstructure, and neck design. Radiological evaluations will be conducted based on radiographs obtained at the time of implant placement and 3 months after prosthetic loading. And measurement pre op post op fractal values

    180 days

Study Arms (1)

RTEU Oral and Maxillofacial Surgery

EXPERIMENTAL
Other: dental implant

Interventions

Digital panoramic radiographs taken during the patients' treatment periods (T0, T1) were used in the study. Measurements of marginal bone levels on radiographs were performed using the "Image J" software. The distance between the most coronal part of the implant neck and the most apical part of the defect caused by marginal bone loss was measured. Fractal analysis (FA) was conducted on panoramic radiographs (OPG) with a size of 2952x1435 pixels and a depth of 32 bits. FA on these radiographs at T0 and T1 times was performed using the box counting method determined by White and Rudolp with the ImageJ program(23).

RTEU Oral and Maxillofacial Surgery

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Implants with a minimum length of 8 mm
  • Implants with a minimum diameter of 3.5 mm
  • Availability of panoramic and periapical radiographs at T0 (immediately after surgery) and T1 (3 months after prosthetic loading).

You may not qualify if:

  • Presence of a systemic condition hindering dental implant treatment and routine check-ups
  • History of regular alcohol/tobacco use
  • Presence of severe parafunctional habits (bruxism, etc.)
  • Prior grafting procedures before dental implant placement
  • Implant failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Recep Tayyip Erdogan University Oral an Mazillofacial Surgery

Rize, Merkez, 53000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Peri-ImplantitisBone Diseases, Metabolic

Interventions

Dental Implants

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dental MaterialsBiomedical and Dental MaterialsDental ProsthesisProsthodonticsDentistryProstheses and ImplantsEquipment and SuppliesManufactured MaterialsTechnology, Industry, and Agriculture

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

November 13, 2023

First Posted

November 28, 2023

Study Start

April 1, 2023

Primary Completion

June 15, 2023

Study Completion

January 25, 2024

Last Updated

January 28, 2025

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations