A Study of the Crestal Bone Loss Around Bone Level Versus Tissue Level Implants in Non-compliant Patients With Healthy or Reduced Periodontium After 5-8 Years in Function

NCT04942808 | Unknown

• 1 other identifier: FMDA9/21
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

The goal is to evaluate, after 5 to 8 years, the marginal bone loss around tissue-level implants and bone-level implants in patients who have not followed the maintenance program. Medical records of patients who have been implanted for at least 5 to 8 years and who have been lost during this period are collected from three private clinics in Beirut,Lebanon and the Saint Joseph University Health Center in Beirut,Lebanon. On an individual sheet, the patient as well as the implants data will be noted. Patients will be called for reevaluation after 5-8 years. After signing the informed consent, the measurements by a PCP-15 probe of the plaque index (FMPS) and the bleeding index (FMBS) as well as the height of the keratinized tissue are indicated on the sheet. If the smoking status has changed, this will be mentioned too. The marginal bone loss will be measured on the X-rays taken immediately after the implant placement, after 1 year of loading and then at the reevaluation session.

Conditions

Periimplantitis; Marginal Bone Loss

Keywords

Oral hygiene; Dental implant; Periodontal maintenance; Marginal bone loss; Tissue level implant; Bone level implant; Internal connection; External connection

Outcome Measures

Primary Outcomes (2)

• Marginal bone loss

  It will be measured mesially and distally on each implant platform until the bone's first coronal contact with the implant. Then, the total bone loss on each implant will be calculated. This is done on the software in millimeters.

  5 to 8 years

• Level of oral hygiene

  The second factor studied is the level of hygiene which will be calculated by measuring the plaque index and bleeding on probing. This is done with a PCP-15 periodontal probe by a light sweeping movement at the level of the 4 sites of each tooth and implant and then written on the personalized card for each patient.

  5 to 8 years

Secondary Outcomes (8)

• Smoking status

  5 to 8 years

• Periodontal status

  5 to 8 years

• success and survival of the implant

  5 to 8 years

• Years in function

  5 to 8 years

• Height and thickness of the peri-implant keratinized mucosa

  5 to 8 years

Other Outcomes (5)

• Implant position

  5 to 8 years

• Type of prosthesis

  5 to 8 years

• Surgical times

  5 to 8 years

Interventions

Periapical radiographs RADIATION

Periapical radiographs on reevaluation

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

All patients who had implants between 2012 and 2015 and who did not follow a maintenance program and whose inclusion criteria are present will be included in the study.

You may qualify if:

• Patients who have undergone the initial phase followed by implant placement in the posterior region.
• Implants placed for more than 5 years.
• The implant systems selected are:
• Tissue Level Implants: Straumann (Straumann Dental Implants System, Switzerland),
• Bone Level implants: Branemark, 3i Biomet (external and internal connection), Nobel replace and Astra.
• Patients who did not comply with the maintenance program and who missed more than 30% of appointments.

You may not qualify if:

• Systemic diseases (uncontrolled diabetes, drugs which may affect bone metabolism).
• Totally edentulous.
• Severe periodontitis not stabilized
• Inappropriate, unavailable or distorted x-rays.
• Augmented sites.
• Implants placed at a supra or infraosseous level.
• Implants placed immediately after extraction.

Sponsors & Collaborators

• Saint-Joseph University: lead

Study Sites (1)

Saint Joseph University of Beirut

Beirut, Mount Lebanon, Lebanon

RECRUITING

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Layal Bou Semaan, DDS

CONTACT

+96178898880; layal.bs@live.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: June 16, 2021
• First Posted: June 28, 2021
• Study Start: June 1, 2021
• Primary Completion: May 29, 2022
• Study Completion: July 29, 2022
• Last Updated: June 28, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

LE (1)