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Completed

NCT Number: NCT06544746

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Saint Joseph University Of Beirut

Beirut, Lebanon

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Compare Marginal Bone Loss (MBL):

    Time frame: Minimum of 3 years post loading

    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.

  2. Compare Emergence angulation assessment

    Time frame: Minimum of 3 years post loading

    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

  3. Compare Emergence profile assessment:

    Time frame: Minimum of 3 years post loading

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

Secondary outcomes

  1. Number of Platform switching

    Time frame: Minimum of 3 years post loading

    Available or not

  2. Height of Abutments

    Time frame: Minimum of 3 years post loading

    Height measurement of the abutment. Measured in mm

Sponsors and collaborators

Lead sponsor

Saint-Joseph University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 9, 2024
Registry last updated
Aug 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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