Dental Implant FailedNCT03715439
Evaluation of Dental Implants Placed in Preserved and Non-preserved Post-extraction Ridges
An observational study of Dental Implant Failed and Platelet-rich Fibrin, run by Rio de Janeiro State University at 2 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implant Failed, Platelet-rich Fibrin, Alveolar Rege Preservation
- What is being tested?
- Dental implant
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 2 sitesBrazil
- Study dates
- 13 Nov 2018to 1 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Systemic diseases related with healing disorders
- Poor oral hygiene
- Pregnant or lactating patient
- Use of flap elevation for dental extraction
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Rio de Janeiro State University
Rio de Janeiro, 20551-030
Rio de Janeiro State University
Rio de Janeiro
About this study
Official title: 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.
- Conditions
- Dental Implant Failed, Platelet-rich Fibrin, Alveolar Rege Preservation, Alveolar Bone Loss
- Being tested
- Dental implant
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental implantDevice
A single dental implant was inserted 3 months after tooth extraction
| Study group | Role | What they receive |
|---|---|---|
| Leucocyte- and Platelet-rich Fibrin | Dental implant placed into post-extraction sites preserved with leucocyte- and platelet-rich fibrin Receives: Device: Dental implant | |
| Control | Dental implant placed into non-preserved post-extraction sites Receives: Device: Dental implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 5 years
success rates of the implants
Success is graded in three qualities, depending on the extent and results of performed examinations.
Grade 1.
- Absence of mobility is checked by individual stability testing of the unattached implant.
- 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.
- Severe soft tissue infections, persistent pain, paresthesia, discomfort, etc.
Grade 2.
- Radiographic evaluation
- Severe soft tissue infections, persistent pain, paresthesia, discomfort, etc, are absent.
Grade 3.
- Radiographic evaluation. Peri-implant pathosis, such as a peri-implant radiolucency is absent.
- Severe soft tissue infections, persistent pain, paresthesia, discomfort, etc, are absent.
Measured: 1 year
success rates of the implants
Success is graded in three qualities, depending on the extent and results of performed examinations.
Grade 1.
- Absence of mobility is checked by individual stability testing of the unattached implant.
- 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.
- Severe soft tissue infections, persistent pain, paresthesia, discomfort, etc.
Grade 2.
- Radiographic evaluation
- Severe soft tissue infections, persistent pain, paresthesia, discomfort, etc, are absent.
Grade 3.
- Radiographic evaluation. Peri-implant pathosis, such as a peri-implant radiolucency is absent.
- Severe soft tissue infections, persistent pain, paresthesia, discomfort, etc, are absent.
Measured: 3 years
success rates of the implants
Success is graded in three qualities, depending on the extent and results of performed examinations.
Grade 1.
- Absence of mobility is checked by individual stability testing of the unattached implant.
- 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.
- Severe soft tissue infections, persistent pain, paresthesia, discomfort, etc.
Grade 2.
- Radiographic evaluation
- Severe soft tissue infections, persistent pain, paresthesia, discomfort, etc, are absent.
Grade 3.
- Radiographic evaluation. Peri-implant pathosis, such as a peri-implant radiolucency is absent.
- Severe soft tissue infections, persistent pain, paresthesia, discomfort, etc, are absent.
Measured: 5 years
Secondary outcomes (12)
Marginal Bone Loss
Periapical digital radiographs will be used to make the measurements and evaluations.
Measured: 1 year
Marginal Bone Loss
Periapical digital radiographs will be used to make the measurements and evaluations.
Measured: 3 years
Marginal Bone Loss
Periapical digital radiographs will be used to make the measurements and evaluations.
Measured: 5 years
Pink Esthetic Score
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.
Measured: 1 year
Pink Esthetic Score
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.
Measured: 3 years
Pink Esthetic Score
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.
Measured: 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.
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?
Measured: 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.
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?
Measured: 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.
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?
Measured: 5 years
Patient satisfaction with single-tooth implant treatment measured with the Oral health impact profile-14 questionnaire
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.
Measured: 1 year
Patient satisfaction with single-tooth implant treatment measured with the Oral health impact profile-14 questionnaire
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.
Measured: 3 years
Patient satisfaction with single-tooth implant treatment measured with the Oral health impact profile-14 questionnaire
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start13 Nov 2018
- Primary completion1 Jul 2020
- Study completion1 Jul 2024 (estimated)
Why it stopped: Duo to pandemic period (COVID) the surgical elective procedures were stopped
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Implant FailedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rio de Janeiro State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, João Vitor dos Santos Canellas, DDS MS, Rio de Janeiro State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03715439
- Sponsor's protocol ID
- 72596717.3.0000.5259/2
- Status last verified
- Jun 2022
- First submitted
- 18 Oct 2018
- Last updated
- 8 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03715439
- Acronym / sponsor ID
- 72596717.3.0000.5259/2
- Conditions
- Dental Implant Failed, Platelet-rich Fibrin, Alveolar Rege Preservation, Alveolar Bone Loss
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Duo to pandemic period (COVID) the surgical elective procedures were stopped
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rio de Janeiro State UniversityUniversity, hospital or other
- Study start
- 13 Nov 2018 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 23 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Leucocyte- and Platelet-rich Fibrin | – | Device: Dental implantDental implant placed into post-extraction sites preserved with leucocyte- and platelet-rich fibrin |
| Control | – | Device: Dental implantDental implant placed into non-preserved post-extraction sites |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- Systemic diseases related with healing disorders
- Poor oral hygiene
- Pregnant or lactating patient
- Use of flap elevation for dental extraction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dental implantA single dental implant was inserted 3 months after tooth extraction | Device | Control, Leucocyte- and Platelet-rich Fibrin |
Primary outcome
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.
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.
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: 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.
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.
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.
12 secondary outcomes
Marginal Bone Loss
Time frame: 1 year
Marginal Bone Loss
Time frame: 3 years
Marginal Bone Loss
Time frame: 5 years
Pink Esthetic Score
Time frame: 1 year
Pink Esthetic Score
Time frame: 3 years
Pink Esthetic Score
Time frame: 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
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
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
Patient satisfaction with single-tooth implant treatment measured with the Oral health impact profile-14 questionnaire
Time frame: 1 year
Patient satisfaction with single-tooth implant treatment measured with the Oral health impact profile-14 questionnaire
Time frame: 3 years
Patient satisfaction with single-tooth implant treatment measured with the Oral health impact profile-14 questionnaire
Time frame: 5 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Implant Failed and Platelet-rich Fibrin, run by Rio de Janeiro State University at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
survival rates of the implants (time frame: 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2022.