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

Browse trials for

• Tooth Loss 224
• Gingival Recession 402

Keywords

• Platelet-Rich Fibrin
• Dental Implant

Tooth Loss

224 studies on the registry are indexed under Tooth Loss; 50 are open to participants now.

This study's planned enrollment of 42 is above the median of 30 across 166 interventional studies indexed under Tooth Loss.

Lead sponsor

Universidade Estadual Paulista Júlio de Mesquita Filho is the lead sponsor of 82 studies on the registry; 9 are open to participants now.

Study arms

• 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

• 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

Interventions

• ProcedureTest - 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 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.

  Also known as: Single implant placement with the use of L-PRF membranes

• ProcedureControl - Implant without L-PRF

  Single implant installation surgery in maxillary esthetic area.

  Also known as: Single implant placement without the use of L-PRF membranes

Primary outcomes

1. 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.

   Time frame: Three months

Secondary outcomes

1. 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);

   Time frame: Three months

2. 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)

   Time frame: Three months

3. 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.

   Time frame: Three months

4. 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.

   Time frame: Three months

5. 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.

   Time frame: Three months

6. 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.

   Time frame: Three months

7. 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.

   Time frame: Three months

8. 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.

   Time frame: During the surgical procedure

9. 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.

   Time frame: During the surgical procedure

10. 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.

    Time frame: During the surgical procedure

11. 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.

    Time frame: During the surgical procedure

12. 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)

    Time frame: During the surgical procedure

13. 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.

    Time frame: Three months

Other outcomes

1. Aesthetic (based on the patient's opinion)

   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.

   Time frame: One year

2. Postoperative discomfort

   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.

   Time frame: Seven days

3. Postoperative discomfort (based on analgesics)

   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.

   Time frame: Seven days

4. Evaluation of oral health impact on quality of life, using the Oral Health Impact Profile (OHIP-14) questionnaire.

   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.

   Time frame: One year

Individual participant data

Plan to share: No