Association Between Restorative Emergence Profiles and Peri-implant Bone Loss in Different Implant Systems:

NCT06544746 | Completed

• 1 other identifier: USJ-2023-63
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is evaluate the association between different emergence profile angulation on marginal bone loss progression around different implant systems (bone level, tissue level and switching platform). Does different emergence profile angulation have the same effect on peri-implant marginal bone loss? Standardized periapical radiograph that were captured after crown placement on implants will be compared with the new radiographs done after recalling the patient.

Conditions

Dental Implant-Abutment Designs

Keywords

Bone loss; Emergence profile; Platform switching

Outcome Measures

Primary Outcomes (3)

• Compare Marginal Bone Loss (MBL):

  measured mesially and distally from the implant platform until the first coronal contact of the bone with the implant. Then the total bone loss on each implant is calculated. This is achieved on the software in millimeters.

  Minimum of 3 years post loading

• Compare Emergence angulation assessment

  The EA was calculated as the angle between the implant's long axis and a line tangent to the restoration. First, a line parallel to the implant's long axis was drawn at the outer collar of the implant. Then, another line tangential to the restoration from the platform was drawn. The angle of intersection was measured as the emergence angle. Measured in degree

  Minimum of 3 years post loading

• Compare Emergence profile assessment:

  Each EP was categorized as either concave, straight, or convex.

  Minimum of 3 years post loading

Secondary Outcomes (2)

• Number of Platform switching

  Minimum of 3 years post loading

• Height of Abutments

  Minimum of 3 years post loading

Study Arms (2)

Bone level Implants

Marginal bone loss will be assessed according to the emergence profile in each system of implants. Standardized periapical radiograph that were captured after crown placement on implants will be compared with the new radiographs done after recalling the patient.

Radiation: Periapical radiographs

Tissue Level Implants

Marginal bone loss will be assessed according to the emergence profile in each system of implants. Standardized periapical radiograph that were captured after crown placement on implants will be compared with the new radiographs done after recalling the patient.

Radiation: Periapical radiographs

Interventions

Periapical radiographs RADIATION

oral radiographs taken with the paralleling technique and film holders at 1- and 3-years post-prosthesis insertion with an X-ray apparatus equipped with a long cone and a Rinn Universal Collimator (Dentsply RINN, York, PA, USA). All radiographs were stored on a PC and analyzed with the software program DBSWIN software. Each radiograph was calibrated using the implant diameter and length as reference measures to correct any distortion before measurement. An image processing program was employed to quantify peri-implant MBL, the EA, EP.

Bone level Implants; Tissue Level Implants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with implants placed and prosthesis delivered for over 3 years. Implants in the premolar/molar region. Non-smokers. Good oral hygiene. 237 implant surfaces in 76 patients. Follow-up: 3 to 7 years. Study conducted at Saint Joseph University of Beirut.

You may qualify if:

• Patients who have undergone the initial phase followed by implant placement.
• Implants placed and prosthesis delivered for more than 3 years.
• Implants placed in premolar/molar region
• No reconstructive bone procedure done on the site of study
• Presence of opposing occlusion
• Non-smokers

You may not qualify if:

• Systemic diseases (uncontrolled diabetes, drugs that can affect bone metabolism).
• Total edentulousness.
• Inappropriate, unavailable, or distorted x-rays.
• Implants placed at a supra or infra bone level.
• Implants placed immediately after an extraction.
• Poor oral hygiene (High plaque score FMPS control record \> 30%)
• Smokers
• Signs of peri-implantitis development during the first year following functional loading
• Lack or incomplete information regarding peri-implant conditions (clinical and radiographic documentation at the required study time-points)
• Surgical treatment on the study implants during the first 2 years after peri-implantitis diagnosis

Sponsors & Collaborators

• Saint-Joseph University: lead

Study Sites (1)

Saint Joseph University Of Beirut

Beirut, Lebanon

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Gabriel Menassa, PHD

  Saint Joseph University Of Beirut

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2024
• First Posted: August 9, 2024
• Study Start: December 1, 2022
• Primary Completion: July 15, 2024
• Study Completion: August 1, 2024
• Last Updated: August 13, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)