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

Association Between Restorative Emergence Profiles and Peri-implant Bone Loss in Different Implant Systems: A Retrospective Study With up to 7 Years of Follow up

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.

Study Overview

• Status: Completed
• Conditions: Dental Implant-Abutment Designs
• Intervention / Treatment: Radiation: Periapical radiographs

Detailed Description

The present retrospective study reported the data collected on partially edentulous patients who were restored with fixed implant supported restorations. The implants were inserted in the periodontology department at the Faculty of Dental Medicine at the Saint Joseph University of Beirut, Lebanon, from 2012 to 2019. The study protocol received approval from the Institutional Review Board at Saint Joseph University of Beirut.

Under the guidance of academic members, all surgical procedures were carried out by postgraduate students. For each implant system, the surgical procedure followed the conventional recommendations. Patients got cemented or screw-retained fixed prostheses after adequate healing time of 3 to 6 months.

Patients were urged to practice proper oral hygiene after receiving their final crown. Even though all patients are told to participate in a regular Supportive periodontal therapy program, some of them did not, they were not selected and excluded in this study Patients or implants were excluded under the following conditions: (a) insufficient clinical records; (b) patients with systemic diseases or conditions; (c) smokers; (d) irregular maintenance care; (e) patients with calculus presence on radiographs; (f) implants placed on reconstructed sites; (g) implant-assisted removable prostheses; (h) peri-implantitis diagnosis; (i) failed implants;(j) Bone loss before prothesis delivery (k) previously treated peri-implantitis cases; and (l)Bone level implants placed supracrestally; (m) lack of intra-oral radiographs taken using the paralleling technique at baseline (the first year of prosthesis insertion) and after 3 years.

Patients were called for reassessment appointments after 3-7 years. After signing the informed consent, measurements by a PCP-15(periondontal probe) probe of plaque index (FMPS) and bleeding on probing (FMBS) are indicated on the form. If the smoking status has changed, it is also mentioned.

For data analysis, the following categories were included: implant connection type (bone-level platform switching, bone-level non platform switching, or tissue level); Emergence Angle (mesial and distal, separately); Emergence Profile (mesial and distal, separately); location; history of periodontitis, abutment height. Radiographic and clinical parameters taken at the time implant placement, after prosthetic delivery, and following a minimum of 3 years follow-up visit were provided.

Single and multiple restorations were included.

• Study Type: Observational
• Enrollment (Actual): 76

Contacts and Locations

Study Locations

• Lebanon
  • Beirut, Lebanon
    • Saint Joseph University of Beirut

Participation Criteria

Eligibility Criteria

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

• 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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Platform switching	Available or not	Minimum of 3 years post loading
Height of Abutments	Height measurement of the abutment. Measured in mm	Minimum of 3 years post loading

Collaborators and Investigators

• Sponsor: Saint-Joseph University
• Investigators: Study Director: Gabriel Menassa, PHD, Saint Joseph University of Beirut

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Actual): July 15, 2024
• Study Completion (Actual): August 1, 2024

Study Registration Dates

• First Submitted: August 5, 2024
• First Submitted That Met QC Criteria: August 7, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Actual): August 13, 2024
• Last Update Submitted That Met QC Criteria: August 10, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Bone loss; Emergence profile; Platform switching
• Other Study ID Numbers: USJ-2023-63

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No