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
|Condition or disease||Intervention/treatment||Phase|
|Tooth Loss Recession, Gingival||Procedure: Test - Implant with L-PRF Procedure: Control - Implant without L-PRF||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|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|
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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
|São Jose dos Campos, São Paulo, Brazil, 12245 000|
|Principal Investigator:||Maria A Jardini, Doctor||State of São paulo University|