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Use of Leucocyte- and Platelet-rich Fibrin Membranes in Single Implant

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ClinicalTrials.gov Identifier: NCT03660566
Recruitment Status : Enrolling by invitation
First Posted : September 6, 2018
Last Update Posted : September 6, 2018
Sponsor:
Information provided by (Responsible Party):
Maria Aparecida Neves Jardini, Universidade Estadual Paulista Júlio de Mesquita Filho

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Tooth Loss Recession, Gingival Procedure: Test - Implant with L-PRF Procedure: Control - Implant without L-PRF Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Use of Leucocyte- and Platelet-rich Fibrin (L-PRF) Membranes in Single Implant Placement on Esthetic Area. Randomized Clinical Trial
Actual Study Start Date : August 10, 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : February 2020

Arm Intervention/treatment
Experimental: Test - Implant with L-PRF
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.
Procedure: Test - Implant with L-PRF
The patient's blood will be collected and the tubes (4) will be inserted into a tabletop centrifuge (Kasvi). Using a 2700rpm 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.
Other Name: Single implant placement with the use of L-PRF membranes

Active Comparator: Control - Implant without L-PRF
Patients requiring single implants placement in the esthetic area of maxilla will receive the implant placement only.
Procedure: Control - Implant without L-PRF
Single implant installation surgery in maxillary esthetic area.
Other Name: Single implant placement without the use of L-PRF membranes




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. a) Plaque index (IP) [ Time Frame: Three months ]
    Evaluation of presence and absence of plaque in the gingival margin with the use of plaque evidence. After applying a solution that shows the presence of plaque, the dental surfaces were inspected to check the presence or absence of plaque stained near the gingiva. The index is calculated by dividing the number of surfaces stained by the total number of teeth, and there multiplies by 100 to reach the percentage of surfaces with presence of plaque.

  2. b) Gingival bleeding index (IS) [ Time Frame: Three months ]
    Evaluation of the presence and absence of bleeding in the gingival margin through the gingival sulcus. The index is calculated after penetration of the sulcus by the periodontal probe, bleeding surfaces are noted and then counted. The index is calculated by dividing the number of surfaces that bleed by the total number of teeth and then multiplying by 100 to reach the percentage of bleeding index.

  3. c) Buccal keratinized tissue thickness (ETQv) [ Time Frame: Three months ]
    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.

  4. d) Occlusal keratinized tissue thickness (ETQo) [ Time Frame: Three months ]
    Keratinized tissue thickness measured at the center of the region of interest (RDI) of the occlusal 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.

  5. e) Soft tissue height (ATM) [ Time Frame: Three months ]
    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.

  6. f) Distance between the teeth adjacent to the edentulous space (DED) [ Time Frame: Three months ]
    Measure of the distance between the proximal faces of the teeth adjacent to the edentulous area, using a periodontal probe.

  7. g) Height of keratinized tissue (ATQ) [ Time Frame: Three months ]
    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.

  8. h) Ridge defect (DR) (ridge valley) [ Time Frame: Three months ]
    Distance in millimeters from the buccal mucosa to the imaginary line passing through the vestibular bosses of the adjacent teeth, using a periodontal probe.

  9. i) Vestibular bone plate thickness (ETV) [ Time Frame: Three months ]
    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.

  10. j) Distance between implant and adjacent teeth (DEID) [ Time Frame: Three months ]
    Measurements between the implant to the adjacent teeth, mesial and distal. measured using photos taken during the surgery.

  11. k) Distance from the implant to the imaginary line passing by the buccal aspect of the adjacent teeth (DILIV) [ Time Frame: Three months ]
    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.

  12. l) Distance from the buccal bone plate to the imaginary line of the adjacent teeth (DTOVLI) [ Time Frame: Three months ]
    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.

  13. m) Evaluation of the periodontal biotype (thin or thick) [ Time Frame: Three months ]
    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.


Other Outcome Measures:
  1. Aesthetic (based on the patient's opinion) [ Time Frame: Three months ]
    With a hand mirror, the patient will evaluate peri-implant aesthetic immediately after the installation of the final crown and will be asked to mark, on a Visual Analogic scale (VAS), where the left end of the scale will be "very ugly" and the right "very beautiful ". The right end is the best outcome possible.

  2. Postoperative discomfort [ Time Frame: Seven days ]
    After the implant installation, the patients will be asked to mark, on a Analogic Visual scale (VAS), the postoperative discomfort, where the scale results are "none" in the left and "extreme", in the right. The right end is the best outcome possible.

  3. Postoperative discomfort (based on analgesics) [ Time Frame: Seven days ]

    Patients will be asked to report the number of analgesics ingested on a week. Patients should fill out a chart during the first 7 days after the surgery, at home.

    The best result will be if patients do not take analgesics, or ingested as little as possible, which would show that there was no postoperative pain.


  4. Evaluation of oral health impact on quality of life, using the Oral Health Impact Profile (OHIP-14) questionnaire. [ Time Frame: One year ]
    Evaluate the impact of oral health on patient's quality of life before and 1 year after implant installation. This evaluation will be carried out through the application of a questionnaire with 14 questions (Oral Health Impact Profile: OHIP-14) that assess the patient's perception regarding the impact of oral conditions on their well-being.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
  • Implants in adjacent regions
  • Sites requiring bone augmentation procedure
  • Patients in orthodontic treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03660566


Locations
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Brazil
Maria Jardini
São Jose dos Campos, São Paulo, Brazil, 12245 000
Sponsors and Collaborators
Universidade Estadual Paulista Júlio de Mesquita Filho
Investigators
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Principal Investigator: Maria A Jardini, Doctor State of São paulo University

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Responsible Party: Maria Aparecida Neves Jardini, Clinical Professor, Universidade Estadual Paulista Júlio de Mesquita Filho
ClinicalTrials.gov Identifier: NCT03660566     History of Changes
Other Study ID Numbers: Implante PRF
First Posted: September 6, 2018    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Maria Aparecida Neves Jardini, Universidade Estadual Paulista Júlio de Mesquita Filho:
Platelet-Rich Fibrin
Dental Implant

Additional relevant MeSH terms:
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Tooth Loss
Gingival Recession
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases
Gingival Diseases
Periodontal Atrophy