Evaluation of Dental Implants Placed in Preserved and Non-preserved Post-extraction Ridges

June 4, 2022 updated by: João Vitor dos Santos Canellas, DDS MS, Rio de Janeiro State University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Rio De Janeiro, Brazil, 20551-030
        • Rio de Janeiro State University
      • Rio De Janeiro, Brazil
        • Rio de Janeiro State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability 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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Leucocyte- and Platelet-rich Fibrin
Dental implant placed into post-extraction sites preserved with leucocyte- and platelet-rich fibrin
Device: Dental implant
A single dental implant was inserted 3 months after tooth extraction
Control
Dental implant placed into non-preserved post-extraction sites
Device: Dental implant
A single dental implant was inserted 3 months after tooth extraction

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
survival rates of the implants
Time Frame: 1 year
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
Time Frame: 3 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.
3 years
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.
5 years
success rates of the implants
Time Frame: 1 year

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
Time Frame: 3 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.
3 years
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.
5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Marginal Bone Loss
Time Frame: 1 year
Periapical digital radiographs will be used to make the measurements and evaluations.
1 year
Marginal Bone Loss
Time Frame: 3 years
Periapical digital radiographs will be used to make the measurements and evaluations.
3 years
Marginal Bone Loss
Time Frame: 5 years
Periapical digital radiographs will be used to make the measurements and evaluations.
5 years
Pink Esthetic Score
Time Frame: 1 year
The PES is based on seven variables: mesial papilla, distal papilla, soft-tissue level, soft tissue contour, alveolar process deficiency, soft-tissue color and texture. Each variable was assessed with a 2-1-0 score, with 2 being the best and 0 being the poorest score.
1 year
Pink Esthetic Score
Time Frame: 3 years
The PES is based on seven variables: mesial papilla, distal papilla, soft-tissue level, soft tissue contour, alveolar process deficiency, soft-tissue color and texture. Each variable was assessed with a 2-1-0 score, with 2 being the best and 0 being the poorest score.
3 years
Pink Esthetic Score
Time Frame: 5 years
The PES is based on seven variables: mesial papilla, distal papilla, soft-tissue level, soft tissue contour, alveolar process deficiency, soft-tissue color and texture. Each variable was assessed with a 2-1-0 score, with 2 being the best and 0 being the poorest 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.
Time Frame: 1 year
Questions: Are you satisfied with the aesthetic outcome of the gums surrounding this implant? Are you satisfied with the function of your implant-supported tooth? Would you undergo the same procedure again?
1 year
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.
Time Frame: 3 years
Questions: Are you satisfied with the aesthetic outcome of the gums surrounding this implant? Are you satisfied with the function of your implant-supported tooth? Would you undergo the same procedure again?
3 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.
Time Frame: 5 years
Questions: Are you satisfied with the aesthetic outcome of the gums surrounding this implant? Are you satisfied with the function of your implant-supported tooth? Would you undergo the same procedure again?
5 years
Patient satisfaction with single-tooth implant treatment measured with the Oral health impact profile-14 questionnaire
Time Frame: 1 year
The questionnaire was divided into seven domains, containing two questions each, resulting in a total of 14 questions. The domains were functional limitation physical disability, physical pain, psychological disability, psychological discomfort, social disability and handicap. The overall OHIP-14 score is the mean of the 14 questions. The questions pertained to seven domains and were averaged on a scale of 0-4, with 0 defined as "never" a problem and 4 defined as "very often" a problem.
1 year
Patient satisfaction with single-tooth implant treatment measured with the Oral health impact profile-14 questionnaire
Time Frame: 3 years
The questionnaire was divided into seven domains, containing two questions each, resulting in a total of 14 questions. The domains were functional limitation physical disability, physical pain, psychological disability, psychological discomfort, social disability and handicap. The overall OHIP-14 score is the mean of the 14 questions. The questions pertained to seven domains and were averaged on a scale of 0-4, with 0 defined as "never" a problem and 4 defined as "very often" a problem.
3 years
Patient satisfaction with single-tooth implant treatment measured with the Oral health impact profile-14 questionnaire
Time Frame: 5 years
The questionnaire was divided into seven domains, containing two questions each, resulting in a total of 14 questions. The domains were functional limitation physical disability, physical pain, psychological disability, psychological discomfort, social disability and handicap. The overall OHIP-14 score is the mean of the 14 questions. The questions pertained to seven domains and were averaged on a scale of 0-4, with 0 defined as "never" a problem and 4 defined as "very often" a problem.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rio de Janeiro State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 13, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 18, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 19, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 23, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 8, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 72596717.3.0000.5259/2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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