Tooth LossNCT03660566
Use of Leucocyte- and Platelet-rich Fibrin Membranes in Single Implant
A study testing Test - Implant with L-PRF in people with Tooth Loss and Recession, Gingival, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 1 site in Brazil.
Trial summary
The objective of this randomized controlled clinical trial is to evaluate the increase of soft tissue thickness around single implants installed in maxillary esthetic area with the use of Leucocyte-Platelet rich Fibrin (L-PRF) membranes. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tooth Loss, Recession, Gingival
- What is being tested?
- Test - Implant with L-PRF
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Aug 2018to 20 Nov 2020
- Phase
- Interventional
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients of at least 20 years of age, systemically healthy, with satisfactory oral hygiene assessed by plaque index and gingival index of less than 25% (O'Leay et al. 1972).
- Patients requiring single implant placement in anterior maxilla (premolar to premolar)
- Buccal soft tissue thickness of at least 2mm
- Patients who agreed to participate in the study and signed a written consent (Resolution nº196 of October 1996 and the Code of Professional Ethics Dental - C.F.O. - 179/93)
Who cannot join
- Smokers
- Patients with parafunctional habits, such as bruxism
- Patients who need other types of rehabilitation, such as removable prostheses
- Pregnant or lactating
- Patients with uncontrolled systemic diseases (cardiovascular alterations, blood disorders, diseases that affect bone metabolism, immunodeficiencies, diabetes)
- Patients who use drugs that interfere with wound healing or contraindicate the surgical procedure, such as gingival growth related drugs
Show all 9Show fewer
- Implants in adjacent regions
- Sites requiring bone augmentation procedure
- Patients in orthodontic treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Leucocyte- and Platelet-rich Fibrin (L-PRF) Membranes in Single Implant Placement on Esthetic Area. Randomized Clinical Trial
The objective of this randomized controlled clinical trial is to evaluate the increase of soft tissue thickness around single implants installed in maxillary esthetic area with the use of Leucocyte-Platelet rich Fibrin (L-PRF) membranes. The sample is of 42 individuals, where the control group (n = 21) will receive single implant placement only, while the test group will receive single implant placement with L-PRF membranes.
Read the detailed description
The greatest challenge in implantology is to achieve a satisfactory esthetic result. A new platelet concentrate protocol, named Leucocyte and platelet-rich Fibrin (L-PRF), has been developed in France. Research has shown positive results using L-PRF during implant placement, as improving soft tissue healing and bone formation, leading to higher esthetic level and greater implant stability. The aim of this study is to evaluate if the use of PRF associated to implant placement in esthetic area presents superior aesthetic result and soft tissue thickness increase when compared to implant placement without graft. Forty-two patients requiring single implant placement in the esthetic area of the maxilla will be randomly divided into test group (implant + L-PRF) and control group (implant without graft). Surgical procedures will be performed by a single operator. The rates of soft tissue thickness, esthetic and comfort will be evaluated at baseline and 3 months after the procedure.
- Conditions
- Tooth Loss, Recession, Gingival
- Being tested
- Test - Implant with L-PRF, Control - Implant without L-PRF
- Keywords
- Platelet-Rich Fibrin, Dental Implant
- Medical subject headings
- Tooth Loss, Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test - Implant with L-PRFProcedure or surgery
Also called Single implant placement with the use of L-PRF membranes
The patient's blood will be collected and the tubes (4) will be inserted into a tabletop centrifuge (Kasvi). Using a 2500rpm for 12 minutes protocol, the leucocyte- and platelet-rich fibrin clot will be prepared using a kit consisting of a perforated metal box where the clots will be positioned and covered by a metal plaque. The pressure exerted on the clot will lead to the formation of L-PRF membranes, which will be used to cover the ridge after placement of the implant. Then, the flap will be sutured.
Control - Implant without L-PRFProcedure or surgery
Also called Single implant placement without the use of L-PRF membranes
Single implant installation surgery in maxillary esthetic area.
| Study group | Role | What they receive |
|---|---|---|
| Test - Implant with L-PRF | Experimental | Patients requiring single implants placement in the esthetic area of maxilla will receive the implant placement with the use of Leucocyte- and Platelet-rich fibrin (L-PRF) membranes. Receives: Procedure: Test - Implant with L-PRF |
| Control - Implant without L-PRF | Active comparator | Patients requiring single implants placement in the esthetic area of maxilla will receive the implant placement only. Receives: Procedure: Control - Implant without L-PRF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gain of peri-implant soft tissue thickness
A single investigator, who is not the operator, is responsible for the measurements of the patients. The examiner will be judged calibrated. The calibration will be made by examination of soft tissue thickness of 5 patients, twice, in a range of 48 hours. The correlation test will be used to verify the reproducibility of intra-examining measures, with a maximum value of 0.8. To ensure that the measures at baseline and postoperative evaluation will be performed at the same place, we will use a stent, made of condensation silicone (Optosil - Heraeus Kulzer), so as to cover the edentulous region and the regions of interest described by Zeltner et al. (2017). During measurements of soft tissue thickness, the stent will be used so that the tissue perforation site will be standardized, according to a marking on its surface. An endodontic spacer will be used for tissue perforation, and the thickness will be evaluated using a digital caliper.
Measured: Three months
Secondary outcomes (13)
a) Plaque index (IP, Ainamo e Bay. 1975)
Assessment of presence or absence of plaque in a dichotomous pattern (0 - absence of visible plaque; 1 - presence of visible plaque);
Measured: Three months
b) Gingival bleeding index (IG, Ainamo & Bay, 1975)
Assessment of presence or absence of bleeding in the gingival margin in a dichotomous pattern (0 - no bleeding; 1 - presence of bleeding)
Measured: Three months
c) Buccal keratinized tissue thickness (ETQv)
Keratinized tissue thickness measured at the center of the region of interest (RDI) of the buccal surface of the ridge. To measure the tissue thickness, a guiding device will be made to standardize the region to be measured and then, at a specific point, the mucosa will be punctured with an endodontic spacer and the thickness marked with a rubber marker. Then, using a digital caliper, the thickness will be measured.
Measured: Three months
d) Ridge defect (DR) (ridge valley)
Distance in millimeters from the buccal mucosa to the imaginary line passing through the vestibular bosses of the adjacent teeth, using a periodontal probe.
Measured: Three months
e) Soft tissue height (ATM)
Distance from the top of the gingival tissue on the edge of the ridge to the top of the stent, measured using a endodontic spacer with rubber marker to measure height, and then measure with a digital caliper.
Measured: Three months
f) Height of keratinized tissue (ATQ)
Vertical distance in millimeters measured on the center of the ridge on the buccal aspect of the edentulous ridge to the mucogingival line, using a periodontal probe.
Measured: Three months
g) Distance between the teeth adjacent to the edentulous space (DED)
Measure of the distance between the proximal faces of the teeth adjacent to the edentulous area, using a periodontal probe.
Measured: Three months
h) Vestibular bone plate thickness (ETV)
The thickness of the buccal bone plate, measured in millimeters, after the perforations of the ridge prior to implant installation. Measured using photos taken during the surgery.
Measured: During the surgical procedure
i) Distance between implant and adjacent teeth (DEID)
Measurements between the implant to the adjacent teeth, mesial and distal. measured using photos taken during the surgery.
Measured: During the surgical procedure
j) Distance from the implant to the imaginary line passing by the buccal aspect of the adjacent teeth (DILIV)
Measured from the vestibular aspect of the implant to the imaginary line passing through the buccal faces of the adjacent teeth. Measured using photos taken during the surgery.
Measured: During the surgical procedure
k) Distance from the buccal bone plate to the imaginary line of the adjacent teeth (DTOVLI)
Measured from the buccal bone plate to the imaginary line of the buccal faces of the adjacent teeth, measured using photos taken during the surgery.
Measured: During the surgical procedure
l) Distance from the interproximal bone crest to the cementum-enamel junction of neighboring teeth (DCOJCE)
Linear measurement from the top of the bone crest to the JCE of the mesial and distal neighboring teeth to the edentulous space (with a periodontal probe)
Measured: During the surgical procedure
m) Evaluation of the periodontal biotype (thin or thick)
Classified on thin or thick periodontal biotype, according to Olsson and Lindhe, 1991 and Kan et al., 2010. Thin, if the marginal vestibular gingiva is more delicate, the papillae are high and thin and the crown of the central incisors are triangular shaped; Thick if the marginal gingiva is thicker, papillae are short and the central incisors are square shaped.
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study start10 Aug 2018
- Primary completion21 Jul 2020
- Study completion20 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth LossStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita Filho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Aparecida Neves Jardini, Universidade Estadual Paulista Júlio de Mesquita Filho
- Investigators
- Maria A Jardini, Doctor, Principal investigator, State of São paulo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03660566
- Sponsor's protocol ID
- Implante PRF
- Status last verified
- Sep 2020
- First submitted
- 4 Jul 2018
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Leucocyte- and Platelet-rich Fibrin (L-PRF) Membranes in Single Implant Placement on Esthetic Area. Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03660566
- Acronym / sponsor ID
- Implante PRF
- Conditions
- Tooth Loss, Recession, Gingival
- Keywords
- Platelet-Rich Fibrin, Dental Implant
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita FilhoUniversity, hospital or other
- Study start
- 10 Aug 2018 (actual)
- Primary completion
- 21 Jul 2020 (actual)
- Study completion
- 20 Nov 2020 (estimated)
- First posted
- 6 Sep 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.
The objective of this randomized controlled clinical trial is to evaluate the increase of soft tissue thickness around single implants installed in maxillary esthetic area with the use of Leucocyte-Platelet rich Fibrin (L-PRF) membranes. The sample is of 42 individuals, where the control group (n = 21) will receive single implant placement only, while the test group will receive single implant placement with L-PRF membranes.
Detailed description
The greatest challenge in implantology is to achieve a satisfactory esthetic result. A new platelet concentrate protocol, named Leucocyte and platelet-rich Fibrin (L-PRF), has been developed in France. Research has shown positive results using L-PRF during implant placement, as improving soft tissue healing and bone formation, leading to higher esthetic level and greater implant stability. The aim of this study is to evaluate if the use of PRF associated to implant placement in esthetic area presents superior aesthetic result and soft tissue thickness increase when compared to implant placement without graft. Forty-two patients requiring single implant placement in the esthetic area of the maxilla will be randomly divided into test group (implant + L-PRF) and control group (implant without graft). Surgical procedures will be performed by a single operator. The rates of soft tissue thickness, esthetic and comfort will be evaluated at baseline and 3 months after the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test - Implant with L-PRF | Experimental | Procedure: Test - Implant with L-PRFPatients requiring single implants placement in the esthetic area of maxilla will receive the implant placement with the use of Leucocyte- and Platelet-rich fibrin (L-PRF) membranes. |
| Control - Implant without L-PRF | Active comparator | Procedure: Control - Implant without L-PRFPatients requiring single implants placement in the esthetic area of maxilla will receive the implant placement only. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients of at least 20 years of age, systemically healthy, with satisfactory oral hygiene assessed by plaque index and gingival index of less than 25% (O'Leay et al. 1972).
- Patients requiring single implant placement in anterior maxilla (premolar to premolar)
- Buccal soft tissue thickness of at least 2mm
- Patients who agreed to participate in the study and signed a written consent (Resolution nº196 of October 1996 and the Code of Professional Ethics Dental - C.F.O. - 179/93)
Key exclusion criteria (9 listed)
- Smokers
- Patients with parafunctional habits, such as bruxism
- Patients who need other types of rehabilitation, such as removable prostheses
- Pregnant or lactating
- Patients with uncontrolled systemic diseases (cardiovascular alterations, blood disorders, diseases that affect bone metabolism, immunodeficiencies, diabetes)
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 |
|---|---|---|
| Test - Implant with L-PRFAlso: Single implant placement with the use of L-PRF membranesThe patient's blood will be collected and the tubes (4) will be inserted into a tabletop centrifuge (Kasvi). Using a 2500rpm for 12 minutes protocol, the leucocyte- and platelet-rich fibrin clot will be prepared using a kit consisting of a perforated metal box where the clots will be positioned and covered by a metal plaque. The pressure exerted on the clot will lead to the formation of L-PRF membranes, which will be used to cover the ridge after placement of the implant. Then, the flap will be sutured. | Procedure or surgery | Test - Implant with L-PRF |
| Control - Implant without L-PRFAlso: Single implant placement without the use of L-PRF membranesSingle implant installation surgery in maxillary esthetic area. | Procedure or surgery | Control - Implant without L-PRF |
Primary outcome
Gain of peri-implant soft tissue thickness
Time frame: Three months
A single investigator, who is not the operator, is responsible for the measurements of the patients. The examiner will be judged calibrated. The calibration will be made by examination of soft tissue thickness of 5 patients, twice, in a range of 48 hours. The correlation test will be used to verify the reproducibility of intra-examining measures, with a maximum value of 0.8. To ensure that the measures at baseline and postoperative evaluation will be performed at the same place, we will use a stent, made of condensation silicone (Optosil - Heraeus Kulzer), so as to cover the edentulous region and the regions of interest described by Zeltner et al. (2017). During measurements of soft tissue thickness, the stent will be used so that the tissue perforation site will be standardized, according to a marking on its surface. An endodontic spacer will be used for tissue perforation, and the thickness will be evaluated using a digital caliper.
13 secondary outcomes
a) Plaque index (IP, Ainamo e Bay. 1975)
Time frame: Three months
b) Gingival bleeding index (IG, Ainamo & Bay, 1975)
Time frame: Three months
c) Buccal keratinized tissue thickness (ETQv)
Time frame: Three months
d) Ridge defect (DR) (ridge valley)
Time frame: Three months
e) Soft tissue height (ATM)
Time frame: Three months
f) Height of keratinized tissue (ATQ)
Time frame: Three months
g) Distance between the teeth adjacent to the edentulous space (DED)
Time frame: Three months
h) Vestibular bone plate thickness (ETV)
Time frame: During the surgical procedure
i) Distance between implant and adjacent teeth (DEID)
Time frame: During the surgical procedure
j) Distance from the implant to the imaginary line passing by the buccal aspect of the adjacent teeth (DILIV)
Time frame: During the surgical procedure
k) Distance from the buccal bone plate to the imaginary line of the adjacent teeth (DTOVLI)
Time frame: During the surgical procedure
l) Distance from the interproximal bone crest to the cementum-enamel junction of neighboring teeth (DCOJCE)
Time frame: During the surgical procedure
m) Evaluation of the periodontal biotype (thin or thick)
Time frame: Three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Individual participant dataSharing planned: No
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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.
Maria A Jardini, Doctor principal investigator
State of São paulo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test - Implant with L-PRF in people with Tooth Loss and Recession, Gingival, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 1 site 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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
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?
Gain of peri-implant soft tissue thickness (time frame: Three months). 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 16 Sep 2020.