Back to resultsUse of Leucocyte- and Platelet-rich Fibrin Membranes in Single Implant
Primary Purpose
Tooth Loss, Recession, Gingival
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Test - Implant with L-PRF
Control - Implant without L-PRF
Sponsored by
About this trial
This is an interventional treatment trial for Tooth Loss focused on measuring Platelet-Rich Fibrin, Dental Implant
Eligibility 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
Sites / Locations
- Maria Jardini
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Test - Implant with L-PRF
Control - Implant without L-PRF
Arm Description
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.
Patients requiring single implants placement in the esthetic area of maxilla will receive the implant placement only.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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);
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)
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.
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.
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.
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.
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.
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.
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.
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.
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.
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)
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.
Full Information
NCT ID
NCT03660566
First Posted
July 4, 2018
Last Updated
September 15, 2020
Sponsor
Universidade Estadual Paulista Júlio de Mesquita Filho
1. Study Identification
Unique Protocol Identification Number
NCT03660566
Brief Title
Use of Leucocyte- and Platelet-rich Fibrin Membranes in Single Implant
Official Title
Use of Leucocyte- and Platelet-rich Fibrin (L-PRF) Membranes in Single Implant Placement on Esthetic Area. Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 10, 2018 (Actual)
Primary Completion Date
July 21, 2020 (Actual)
Study Completion Date
November 20, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Estadual Paulista Júlio de Mesquita Filho
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Loss, Recession, Gingival
Keywords
Platelet-Rich Fibrin, Dental Implant
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Test - Implant with L-PRF
Arm Type
Experimental
Arm Description
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.
Arm Title
Control - Implant without L-PRF
Arm Type
Active Comparator
Arm Description
Patients requiring single implants placement in the esthetic area of maxilla will receive the implant placement only.
Intervention Type
Procedure
Intervention Name(s)
Test - Implant with L-PRF
Other Intervention Name(s)
Single implant placement with the use of L-PRF membranes
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Control - Implant without L-PRF
Other Intervention Name(s)
Single implant placement without the use of L-PRF membranes
Intervention Description
Single implant installation surgery in maxillary esthetic area.
Primary Outcome Measure Information:
Title
Gain of peri-implant soft tissue thickness
Description
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 Outcome Measure Information:
Title
a) Plaque index (IP, Ainamo e Bay. 1975)
Description
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
Title
b) Gingival bleeding index (IG, Ainamo & Bay, 1975)
Description
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
Title
c) Buccal keratinized tissue thickness (ETQv)
Description
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
Title
d) Ridge defect (DR) (ridge valley)
Description
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
Title
e) Soft tissue height (ATM)
Description
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
Title
f) Height of keratinized tissue (ATQ)
Description
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
Title
g) Distance between the teeth adjacent to the edentulous space (DED)
Description
Measure of the distance between the proximal faces of the teeth adjacent to the edentulous area, using a periodontal probe.
Time Frame
Three months
Title
h) Vestibular bone plate thickness (ETV)
Description
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
Title
i) Distance between implant and adjacent teeth (DEID)
Description
Measurements between the implant to the adjacent teeth, mesial and distal. measured using photos taken during the surgery.
Time Frame
During the surgical procedure
Title
j) Distance from the implant to the imaginary line passing by the buccal aspect of the adjacent teeth (DILIV)
Description
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
Title
k) Distance from the buccal bone plate to the imaginary line of the adjacent teeth (DTOVLI)
Description
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
Title
l) Distance from the interproximal bone crest to the cementum-enamel junction of neighboring teeth (DCOJCE)
Description
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
Title
m) Evaluation of the periodontal biotype (thin or thick)
Description
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 Pre-specified Outcome Measures:
Title
Aesthetic (based on the patient's opinion)
Description
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
Title
Postoperative discomfort
Description
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
Title
Postoperative discomfort (based on analgesics)
Description
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
Title
Evaluation of oral health impact on quality of life, using the Oral Health Impact Profile (OHIP-14) questionnaire.
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria A Jardini, Doctor
Organizational Affiliation
State of São paulo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maria Jardini
City
São Jose dos Campos
State/Province
São Paulo
ZIP/Postal Code
12245 000
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Use of Leucocyte- and Platelet-rich Fibrin Membranes in Single Implant
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