Dental Implants Clinical Trial
Official title:
Leukocyte and Platelet-rich Fibrin (L-PRF) Effects on Alveolar Ridge Preservation. A Randomized Controlled Clinical Trial With One Year Follow up
Verified date | December 2022 |
Source | Universidad Complutense de Madrid |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The goal of this clínical trial is to compare in patients needing extraction of anterior teeth the effects of leukocyte-and platelet-rich fibrin (L-PRF) for alveolar ridge preservation versus spontaneous healing. The main questions it aims to answer are: - Does L-PRF use as alveolar ridge preservation material diminish volumetric changes in the alveolar ridge produced after tooth extraction and further bone regeneration needs? - Does it have any advantage for wound healing and patient-related outcomes? Participants will undergo - Tooth extraction - Alveolar ridge preservation/ spontaneous healing - Implant placement Researchers will compare alveolar ridge preservation with L-PRF with spontaneous healing to see if there is an effect on reducing ridge dimensional changes happening after tooth extraction.
Status | Active, not recruiting |
Enrollment | 28 |
Est. completion date | May 30, 2023 |
Est. primary completion date | November 30, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Systemically healthy patients =18 years old - Need for extraction of a tooth in the anterior area (position of second premolar to second premolar in maxilla or mandible) that needs to be replaced by an implant-supported restoration - Presence of natural teeth mesially and distally of tooth to be extracted, periodontally healthy (probing depths <5 mm without bleeding on probing). Exclusion Criteria: - Systemic conditions affecting bone or soft tissue healing - Smokers of more than 10 cigarettes a day or equivalent to cigarettes - Breastfeeding or pregnant women - Patients without availability to attend follow-up visits or patients rejecting to sign the informed consent |
Country | Name | City | State |
---|---|---|---|
Spain | Complutense University of Madrid | Madrid |
Lead Sponsor | Collaborator |
---|---|
Universidad Complutense de Madrid |
Spain,
Anwandter A, Bohmann S, Nally M, Castro AB, Quirynen M, Pinto N. Dimensional changes of the post extraction alveolar ridge, preserved with Leukocyte- and Platelet Rich Fibrin: A clinical pilot study. J Dent. 2016 Sep;52:23-9. doi: 10.1016/j.jdent.2016.06. — View Citation
Barone A, Aldini NN, Fini M, Giardino R, Calvo Guirado JL, Covani U. Xenograft versus extraction alone for ridge preservation after tooth removal: a clinical and histomorphometric study. J Periodontol. 2008 Aug;79(8):1370-7. doi: 10.1902/jop.2008.070628. — View Citation
Choukroun, J., Adda, F., Schoeffler, C., & Vervelle, A. (2001). The opportunity in perio-implantology: The PRF. Implantodontie, 42, 55-62.
Dohan Ehrenfest DM, de Peppo GM, Doglioli P, Sammartino G. Slow release of growth factors and thrombospondin-1 in Choukroun's platelet-rich fibrin (PRF): a gold standard to achieve for all surgical platelet concentrates technologies. Growth Factors. 2009 Feb;27(1):63-9. doi: 10.1080/08977190802636713. — View Citation
Furhauser R, Florescu D, Benesch T, Haas R, Mailath G, Watzek G. Evaluation of soft tissue around single-tooth implant crowns: the pink esthetic score. Clin Oral Implants Res. 2005 Dec;16(6):639-44. doi: 10.1111/j.1600-0501.2005.01193.x. — View Citation
Ortiz-Vigon A, Suarez I, Martinez-Villa S, Sanz-Martin I, Bollain J, Sanz M. Safety and performance of a novel collagenated xenogeneic bone block for lateral alveolar crest augmentation for staged implant placement. Clin Oral Implants Res. 2018 Jan;29(1):36-45. doi: 10.1111/clr.13036. Epub 2017 Jul 14. — View Citation
Sanz-Martin I, Permuy M, Vignoletti F, Nunez J, Munoz F, Sanz M. A novel methodological approach using superimposed Micro-CT and STL images to analyze hard and soft tissue volume in immediate and delayed implants with different cervical designs. Clin Oral Implants Res. 2018 Oct;29(10):986-995. doi: 10.1111/clr.13365. Epub 2018 Sep 23. — View Citation
Schropp L, Wenzel A, Kostopoulos L, Karring T. Bone healing and soft tissue contour changes following single-tooth extraction: a clinical and radiographic 12-month prospective study. Int J Periodontics Restorative Dent. 2003 Aug;23(4):313-23. — View Citation
Suttapreyasri S, Leepong N. Influence of platelet-rich fibrin on alveolar ridge preservation. J Craniofac Surg. 2013 Jul;24(4):1088-94. doi: 10.1097/SCS.0b013e31828b6dc3. — View Citation
Tan WL, Wong TL, Wong MC, Lang NP. A systematic review of post-extractional alveolar hard and soft tissue dimensional changes in humans. Clin Oral Implants Res. 2012 Feb;23 Suppl 5:1-21. doi: 10.1111/j.1600-0501.2011.02375.x. — View Citation
Temmerman A, Vandessel J, Castro A, Jacobs R, Teughels W, Pinto N, Quirynen M. The use of leucocyte and platelet-rich fibrin in socket management and ridge preservation: a split-mouth, randomized, controlled clinical trial. J Clin Periodontol. 2016 Nov;43 — View Citation
Thalmair T, Fickl S, Schneider D, Hinze M, Wachtel H. Dimensional alterations of extraction sites after different alveolar ridge preservation techniques - a volumetric study. J Clin Periodontol. 2013 Jul;40(7):721-7. doi: 10.1111/jcpe.12111. Epub 2013 May — View Citation
Vignoletti F, Matesanz P, Rodrigo D, Figuero E, Martin C, Sanz M. Surgical protocols for ridge preservation after tooth extraction. A systematic review. Clin Oral Implants Res. 2012 Feb;23 Suppl 5:22-38. doi: 10.1111/j.1600-0501.2011.02331.x. — View Citation
* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Peri implant probing depth | Cuantitative variable: Probing depth (PD). Distance in millimeters m from the bottom of the pocket to the gingival margin. | At implant placement, 6 months and 12 months after loading | |
Other | Peri-implant Plaque index | Cualitative variable: Presence or absence (yes/no) of plaque around 6 points of the implant site. Mesiobuccal, Midbuccal, Distobuccal; Mesiolingual, Midlingual, Distolingual | At implant placement, 6 months and 12 months after loading | |
Other | Bleeding on probing | Cualitative variable: Presence or absence (yes/no) of bleeding after probing in 6 points around the implant site. Mesiobuccal, Midbuccal, Distobuccal; Mesiolingual, Midlingual, Distolingual. | At implant placement, 6 months and 12 months after loading | |
Other | Radiographic changes in bone levels | An analysis of periapical radiographs will be performed to assess changes in bone levels at 12 months after loading. Defined as the distance between the implant shoulder and the first bone-to-implant contact a mesial and distal aspects | At implant placement, 6 months and 12 months after loading | |
Other | Clinical crown dimension | Distance in millimeters from the gingival margin to the incisal edge or occlusal surface. An increase in the value would indicate a recession of the peri-implant mucosa. | At implant loading, 6 months and 12 months follow up | |
Other | Pink Esthetic Score | Pink esthetic index. According to the parameters described by (Furhäuser et al 2005), seven variables are measured to assess the status of the peri-implant soft tissues, among them: mesial papilla, distal papilla, gingival margin level, soft tissue contour, alveolar process, and tissue color and texture.
This index is determined by granting a value of 0, 1 or 2, and combine to give a final score, the maximum final score is 14 points. Scores > or = to 12 mean high esthetic achievement. |
At implant loading, 6 months and 12 months follow up | |
Other | Changes in ridge contour after loading | Cuantitative variable. An image analysis software (SMOP®, Swissmeda, Sweden) will be used to superimpose stl files taken after tooth extraction and 12 months after implant loading. In a sagittal section of the superimposed images linear measurements will be taken to determine horizontal, vertical and volumetric changes. | 12 months after implant loading | |
Primary | Radiographic linear changes in horizontal width of the alveolar ridge | Cuantitative variable. A validated method to superimpose the radiographs will be used (Ortiz-Vigón et al., 2018; Sanz-Martín et al., 2019).A digital imaging software (SMOP®, Swissmeda Ltd©, Zurich, Switzerland) is used to convert DICOM files into STL files. The images from Baseline and 4 months CBCTs were superimposed using common reference points. After a "fine fit" of the two surfaces, it will appear as a merged contour in axial, coronal, and sagittal views. The center of the alveolus will be determined mesiodistally in the occlusal view. Linear changes in width between 4 months and baseline will be determined by horizontal lines drawn perpendicular to the longitudinal axis in the center of the socket. Three measurements will be taken at 1mm (HRW1), 3mm (HRW3), and 5mm (HRW5) below the Bl bone crest. The change will be calculated by subtraction of the 4 months to Baseline distance in millimeters. | From tooth extraction (Baseline) to four months healing (4m) | |
Secondary | Radiographic linear changes height of the alveolar ridge | Cuantitative variable. A validated method to superimpose the radiographs will be used (Ortiz-Vigón et al., 2018; Sanz-Martín et al., 2019).A digital imaging software (SMOP®, Swissmeda Ltd©, Zurich, Switzerland) is used to convert DICOM files into STL files. The images from Baseline and 4 months CBCTs were superimposed using common reference points. After a "fine fit" of the two surfaces, it will appear as a merged contour in axial, coronal, and sagittal views. The center of the alveolus will be determined mesiodistally in the occlusal view. Vertical changes will be determined by measuring the distance from the most coronal aspect of the crest at 4 months to the crest at baseline at buccal and lingual aspects. | From tooth extraction (Baseline) to four months healing (4m) | |
Secondary | Changes in ridge contour | Cuantitative variable . A similar superimposition method will be used for ridge contour analysis in STL files (Bienz et al., 2017). An image analysis software (SMOP®, Swissmeda, Sweden) will be used to superimpose STL files taken after tooth extraction and at 4 months. Horizontal lines will be drawn perpendicular to the longitudinal axis in the center of the socket at 1mm, 3mm, and 5mm below the crestal margin. Dimensional changes will be calculated by subtraction of the 4 months to baseline distances in millimeters. Vertical changes will be registered as the distance between contours of both time points in the center of the alveolus. | From tooth extraction (Baseline) to four months healing (4m) | |
Secondary | Volumetric changes | Cuantitative variable. Changes in volume of a region of interest (ROI) delimited by the crestal margin, the mesial and distal line angles of adjacent teeth, and extending 5 mm apically will be calculated in the superimposed images by the software (SMOP®, Swissmeda, Sweden) | From tooth extraction (Baseline) to four months healing (4m) | |
Secondary | Patient reported outcome measures | Cuantitative variable. Patients perception of pain, inflammation, bleeding and functional capacity reported in a VISUAL ANALOGUE (VAS) scale, with scores fro 0-10.
Regarding inflammation, pain and bleeding lower scores will mean better performance of intervention and higher outcomes worse performance. Regarding functional capacity, higher scores will mean better performance and lower scores will mean worse performance. |
At one week, one month and four months visit. | |
Secondary | Bone regeneration needs | Cualitative variable. At the moment of implant planning, bone availability will be assessed and it will be determined if there is a need of bone regeneration previous or simultaneous to implant placement | 4 months after tooth extraction | |
Secondary | Percentage of mineralized bone | Cuantitative variable. Histological analysis. Assessment of the percentage of mineralized bone in the core biopsies taken at implant placement. | 4 months after tooth extraction, during the implant placement surgery. |
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