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Clinical Trials/NCT03715439
NCT03715439
Withdrawn
N/A

Evaluation of Dental Implants Placed in Preserved Post-extraction Ridges With Leucocyte- and Platelet-rich Fibrin: 1, 3 and 5-year Post-loading Outcome of a Randomized Controlled Trial

Rio de Janeiro State University1 site in 1 countryNovember 13, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Dental Implant Failed
Sponsor
Rio de Janeiro State University
Locations
1
Primary Endpoint
survival rates of the implants
Status
Withdrawn
Last Updated
3 years ago

Overview

Brief Summary

A prospective study to evaluate and compare implants placed in preserved versus non-preserved extraction sockets using L-PRF (Leucocyte- and platelet-rich fibrin) after 1, 3 and 5 years.

Registry
clinicaltrials.gov
Start Date
November 13, 2018
End Date
July 1, 2024
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Rio de Janeiro State University
Responsible Party
Principal Investigator
Principal Investigator

João Vitor dos Santos Canellas, DDS MS

DDS MS

Rio de Janeiro State University

Eligibility Criteria

Inclusion Criteria

  • Health patients, American Society of Anesthesiologists (ASA) I or II
  • Patients who need to submit tooth extraction (pre-molar, canine and incisor teeth which present ideal conditions to receive dental implants after 3 months.

Exclusion Criteria

  • Systemic diseases related with healing disorders
  • Poor oral hygiene
  • Pregnant or lactating patient
  • Use of flap elevation for dental extraction

Outcomes

Primary Outcomes

survival rates of the implants

Time Frame: 5 years

The term surviving refers to those implants that are still in the jaw of the patient but either have not met success criteria or have not been tested for success.

success rates of the implants

Time Frame: 5 years

Success is graded in three qualities, depending on the extent and results of performed examinations. Grade 1. 1. Absence of mobility is checked by individual stability testing of the unattached implant. 2. Radiographic evaluation of each implant reveals not more than 1.0 mm of marginal bone loss during the first year of loading, followed by not more than 0.2 mm resorption per year. 3. Severe soft tissue infections, persistent pain, paresthesia, discomfort, etc. Grade 2. 1. Radiographic evaluation 2. Severe soft tissue infections, persistent pain, paresthesia, discomfort, etc, are absent. Grade 3. 1. Radiographic evaluation. Peri-implant pathosis, such as a peri-implant radiolucency is absent. 2. Severe soft tissue infections, persistent pain, paresthesia, discomfort, etc, are absent.

Secondary Outcomes

  • Marginal Bone Loss(5 years)
  • Pink Esthetic Score(5 years)
  • Patient satisfaction - Questions will be scored on 100mm visual analog scales. The patients marked their response on a horizontal line for which the most negative expression corresponded to 0 and the most positive to 100.(5 years)
  • Patient satisfaction with single-tooth implant treatment measured with the Oral health impact profile-14 questionnaire(5 years)

Study Sites (1)

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