NCT03715439

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2018

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 23, 2018

Completed
21 days until next milestone

Study Start

First participant enrolled

November 13, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

June 8, 2022

Status Verified

June 1, 2022

Enrollment Period

1.6 years

First QC Date

October 18, 2018

Last Update Submit

June 4, 2022

Conditions

Dental Implant FailedPlatelet-rich FibrinAlveolar Rege PreservationAlveolar Bone Loss

Outcome Measures

Primary Outcomes (6)

  • survival rates of the implants

    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.

    1 year

  • survival rates of the implants

    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.

    3 years

  • survival rates of the implants

    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.

    5 years

  • success rates of the implants

    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.

    1 year

  • success rates of the implants

    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.

    3 years

  • success rates of the implants

    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.

    5 years

Secondary Outcomes (12)

  • Marginal Bone Loss

    1 year

  • Marginal Bone Loss

    3 years

  • Marginal Bone Loss

    5 years

  • Pink Esthetic Score

    1 year

  • Pink Esthetic Score

    3 years

  • +7 more secondary outcomes

Study Arms (2)

Leucocyte- and Platelet-rich Fibrin

Dental implant placed into post-extraction sites preserved with leucocyte- and platelet-rich fibrin

Device: Dental implant

Control

Dental implant placed into non-preserved post-extraction sites

Device: Dental implant

Interventions

Dental implantDEVICE

A single dental implant was inserted 3 months after tooth extraction

ControlLeucocyte- and Platelet-rich Fibrin

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This study presents the 1,3 and 5-year evaluation of a previously accomplished randomized, clinical study initiated in 2018. The study sample was recruited among patients referred to the School of Dentistry, University of Rio de Janeiro, Brazil for treatment with single-tooth implants.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rio de Janeiro State University

Rio de Janeiro, 20551-030, Brazil

Location

Rio de Janeiro State University

Rio de Janeiro, Brazil

Location

MeSH Terms

Conditions

Alveolar Bone Loss

Interventions

Dental Implants

Condition Hierarchy (Ancestors)

Bone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal AtrophyPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental MaterialsBiomedical and Dental MaterialsDental ProsthesisProsthodonticsDentistryProstheses and ImplantsEquipment and SuppliesManufactured MaterialsTechnology, Industry, and Agriculture
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DDS MS

Study Record Dates

First Submitted

October 18, 2018

First Posted

October 23, 2018

Study Start

November 13, 2018

Primary Completion

July 1, 2020

Study Completion

July 1, 2024

Last Updated

June 8, 2022

Record last verified: 2022-06

Locations

BR(2)