Periimplantitis Clinical Trial
Official title:
A Comparative Observational 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"
NCT number | NCT04942808 |
Other study ID # | FMDA9/21 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 1, 2021 |
Est. completion date | July 29, 2022 |
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.
Status | Recruiting |
Enrollment | 130 |
Est. completion date | July 29, 2022 |
Est. primary completion date | May 29, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Lebanon | Saint Joseph University of Beirut | Beirut | Mount Lebanon |
Lead Sponsor | Collaborator |
---|---|
Saint-Joseph University |
Lebanon,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Implant position | Maxilla or Mandible | 5 to 8 years | |
Other | Type of prosthesis | screwed or sealed | 5 to 8 years | |
Other | Surgical times | One or two | 5 to 8 years | |
Other | Number of implants | Multiple or unitary | 5 to 8 years | |
Other | Implant surface | The implant surface is usually related to the implant type indicated in the patient file | 5 to 8 years | |
Primary | 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 | |
Primary | 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 | Smoking status | Non-smoker, smoker <10 cig/d, smoker equal or > to 10 cig/d, Former smoker | 5 to 8 years | |
Secondary | Periodontal status | Gingivitis or periodontitis with stage and grade | 5 to 8 years | |
Secondary | success and survival of the implant | 1) absence of persistent pain, dysesthesia or paresthesia 2) absence of peri-implant infection with or without suppuration 3) absence of noticeable mobility of the implant and 4) absence of persistent peri-implant bone resorption> 1.5 mm during the first year of loading and 0.2 mm per year for the following years. | 5 to 8 years | |
Secondary | Years in function | Years in function | 5 to 8 years | |
Secondary | Height and thickness of the peri-implant keratinized mucosa | Height and thickness of the peri-implant keratinized mucosa | 5 to 8 years | |
Secondary | Overhang or hiatus or cantilever | Overhang or hiatus or cantilever | 5 to 8 years | |
Secondary | Full mouth plaque score | With a periodontal probe, we measure at 4 sites (vestibular, mesial, distal, palatine / lingual) of each implant and tooth, we note 0 / - in the absence of plaque and 1 / + in the presence of plaque. | 1 year | |
Secondary | Full mouth bleeding score | With a periodontal probe and after a gentle sweeping motion over the marginal surface of the implant, detect the presence or absence of bleeding at the 4 sites of each implant and tooth denoted by 1 / + and 0 / - respectively. | 1 year |
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