Alveolar Ridge PreservationPhase 3NCT05662709
Leukocyte and Platelet-rich Fibrin (L-PRF) Effects on Alveolar Ridge Preservation. A Randomized Controlled Clinical Trial.
A Phase 3 study testing Tooth extraction and Alveolar ridge preservation with L-PRF in people with Alveolar Ridge Preservation and Dental Implants, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alveolar Ridge Preservation, Dental Implants
- What is being tested?
- Tooth extraction and Alveolar ridge preservation with L-PRF
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2019to 30 May 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Leukocyte and Platelet-rich Fibrin (L-PRF) Effects on Alveolar Ridge Preservation. A Randomized Controlled Clinical Trial With One Year Follow up
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.
Read the detailed description
-Objectives
The main objective is to determine if L-PRF use as alveolar ridge preservation material diminishes volumetric changes in the alveolar ridge produced after tooth extraction and needs of bone regeneration previous or simultaneous to implant placement compared to spontaneous healing.
Secondary objectives:
To determine if there are differences in wound healing after the use of L-PRF compared to spontaneous healing.
To investigate if there are differences in Patient Reported Outcome measures after the use of L-PRF compared to spontaneous healing.
To analyse the histologic differences in quality of bone after the use of L-PRF compared to spontaneous healing.
-Material and Methods
Randomized clinical trial developed in an academic onset, parallel groups, single-blinded with one year follow up after implant loading.
Ethical Aspects:
This investigation will be based on compliance with the principles of the Declaration of Helsinki. The ethics committee of Hospital Clínico San Carlos will be in charge of evaluating and approving this protocol. All patients will be fully informed before their inclusion in the study by means of informed consent.
Treatment:
All the participants will be treated by postgraduate students at the Master of Periodontology and Implant dentistry from the Complutense University of Madrid.
Twenty-eight patients in need of extraction will be included in the study. In the baseline visit local anesthesia will be administered and tooth extraction will be performed in the least traumatic way possible. The group will be allocated according to a computer-generated randomization list and given in a sealed envelope. For the test group (L-PRF) venipuncture (median basilica vein, median cubital vein, median cephalic vein) will be performed by a nurse and blood will be drawn into 8 sterile plastic 10 ml tubes without anticoagulant (Vacutainers: IntraSpin™, Intra-lock,USA). L-PRF plugs and membranes will be prepared as described by Choukroun et al 2001. Tubes will be centrifuged for 12 minutes at 2700 rpm using a table centrifuge (IntraSpin™, IntraLock, USA). After centrifugation, clots will be removed from the tubes, separated from red element phase at the base with pliers and placed in a metal tray (Xpression™ Box). Four to five of them will be packed in a cylinder to obtain plugs, and four will be squeezed between the tray and a glass plate to obtain L-PRF membranes. In sockets of the L-PRF group, 2-5 plugs, depending on the size of the socket will be inserted and compressed and membranes will be adapted on top and inserted in vestibular and lingual envelope flaps previously prepared. A crossed horizontal mattress suture (Polyamide 5.0, Supramid™, SMI AG, Steinerberg, Belgium) will be placed on top. In the control group, after extraction, just the suture will be performed to stabilize the coagulum. Patients will be prescribed ibuprofen (600mg t.i.d) or paracetamol (1g t.i.d) and chlorhexidine 0.12% + 0.05% CPC mouth rinse (PerioAid® Tratamiento, Dentaid, Barcelona, Spain) for one week.
Follow up visits:
After extraction, a cone-beam computed tomography (CBCT) scan (i-CAT Classic, Imaging Sciences International, Hatfield, Pennsylvania) and a digital impression (Medit i500 ™, Medit, Seoul, Korea) to obtain a stereolithographic model of the area will be taken.
Sutures will be removed at 7days. Patients will attend follow-up visits at 4 weeks and 4 months to monitor wound healing. Patient reported outcome measures (PROM's) will be registered at 1 and 4 weeks.
Diagnostic for implant placement:
Four months after tooth extraction, the new CBCT will be assessed to see bone availability for implant placement. In this visit a new digital impression will be taken to assess dimensional changes in bone and soft tissue with an image analysis software (SMOP®, Swissmeda, Switzerland).
Implant surgery will be scheduled, it will be determined if bone regeneration is necessary before or simultaneously to implant placement. At the time of implant placement, a biopsy will be taken for histologic analysis with a trephine bur of 2.5mm diameter (Komet, USA) with the aim to obtain a sample of healed bone tissue and perform histologic analysis. After osteotomy, an implant Gold \& Blue (Intralock, USA) will be inserted. If there is no need of bone regeneration, healing abutments will be placed; if there is need of simultaneous bone regeneration the width and height of the defect will be registered and a bone substitute NanoBone®(Intra-lock Iberia, Madrid Spain) and a resorbable collagen membrane (Bio-Gide; Geistlich, Switzerland will be placed, with a submerged healing protocol. Four months late, second stage surgery will be performed. If implant cannot be properly stabilized, a guided bone regeneration will be performed with the same materials and implants will be placed after six months.
After implant placement, a periapical x-ray will be performed, and sutures will be removed after one week.
Implant restoration:
After a healing period of 10 weeks after implant placement (between 4-6 months if bone regeneration has been required), impressions will be taken to make the provisional or final prosthesis, STLs models for ridge changes assessment and implant related variables will be registered.
The day of implant loading, a new standardized periapical x-ray will be taken with a personalized bite block. Peri-implant health related variables will be assessed, and esthetic outcomes will be registered. This will be the baseline visit for the follow up analysis of the implants placed.
Implants follow up:
The implants will be assessed at 6 and 12 months after loading the final prosthesis. In these visits, the same clinical variables related to peri-implant health and aesthetics will be recorded as in the baseline visit (definitive load). Additionally, at 12 months a periapical X-ray will be performed, a digital impression of the treated area will be taken and a satisfaction questionnaire will be given to the patient.
-Sample size calculation
The sample size calculation was based on detecting a mean difference in reduction of the HRW of 2,3mm with an estimated standard deviation (SD) of 1.1 between groups (Thalmair et al., 2013). To detect statistically significant differences (α=0.05) with a 90% power, a minimum of 11 subjects per group are needed, which including an expected 20% drop-out rate, it resuls in a final sample of 14 participants per group.
-Data analysis
Data will be analyzed to compare both treatment modalities. The normality of the distribution will be evaluated using the Kolmogorov-Smirnov test. Depending on the distribution of the data, parametric or non-parametric tests will be used. Quantitative variables will be assessed by means of student´s t test or Mann Whitney´s U test.
Qualitative variables will be expressed through distribution frequencies and will be compared with chi-square tests.
The clinical significance level is set at p<0.05.
- Conditions
- Alveolar Ridge Preservation, Dental Implants
- Being tested
- Tooth extraction, Alveolar ridge preservation with L-PRF
- Keywords
- platelet-rich fibrin, bone regeneration, alveolar ridge preservation, tooth extraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tooth extractionProcedure or surgery
Tooth extraction in the most atraumatic way
Alveolar ridge preservation with L-PRFProcedure or surgery
Blood will be drawn from the patient, centrifugued and leukocyte and platelet-rich fibrin (L-PRF) will be obtained. L-PRF plugs and membranes will be prepared and placed in the socket after extraction
| Study group | Role | What they receive |
|---|---|---|
| L-PRF | Experimental | Test group, alveolar ridge preservation with L-PRF after tooth extraction. Receives: Procedure: Tooth extraction; Procedure: Alveolar ridge preservation with L-PRF |
| Spontaneous Healing (SH) | No intervention | Control group, spontaneous healing of the socket after tooth extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From tooth extraction (Baseline) to four months healing (4m)
Secondary outcomes (6)
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.
Measured: From tooth extraction (Baseline) to four months healing (4m)
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.
Measured: From tooth extraction (Baseline) to four months healing (4m)
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)
Measured: From tooth extraction (Baseline) to four months healing (4m)
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.
Measured: At one week, one month and four months visit.
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
Measured: 4 months after tooth extraction
Percentage of mineralized bone
Cuantitative variable. Histological analysis. Assessment of the percentage of mineralized bone in the core biopsies taken at implant placement.
Measured: 4 months after tooth extraction, during the implant placement surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start1 Apr 2019
- Primary completion30 Nov 2021
- Study completion30 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Alveolar Ridge PreservationStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Controlled clinical trial, 2 groups of patients undergoing tooth extraction, allocated to: * Test group: alveolar ridge preservation with L-PRF * Control group: spontaneous healing of the socket
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carolina Encalada Abad, DDS, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05662709
- Sponsor's protocol ID
- 17/262-O_P
- Status last verified
- Dec 2022
- First submitted
- 7 Dec 2022
- Last updated
- 22 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 19089687Tan 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.
PubMed 22211303Barone 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.
PubMed 18672985Schropp 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.
PubMed 12956475Sanz-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.
PubMed 30246362Vignoletti 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.
PubMed 22211304Furhauser 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.
PubMed 16307569Ortiz-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.
PubMed 28710793Anwandter 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.2016.06.005. Epub 2016 Jun 20.
PubMed 27338946Temmerman 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(11):990-999. doi: 10.1111/jcpe.12612. Epub 2016 Sep 21.
PubMed 27509214Thalmair 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 5.
PubMed 23647007Suttapreyasri 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.
PubMed 23851746
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leukocyte and Platelet-rich Fibrin (L-PRF) Effects on Alveolar Ridge Preservation. A Randomized Controlled Clinical Trial With One Year Follow up
- ClinicalTrials.gov ID
- NCT05662709
- Acronym / sponsor ID
- 17/262-O_P
- Conditions
- Alveolar Ridge Preservation, Dental Implants
- Keywords
- platelet-rich fibrin, bone regeneration, alveolar ridge preservation, tooth extraction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 May 2023 (estimated)
- First posted
- 22 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
-Objectives
The main objective is to determine if L-PRF use as alveolar ridge preservation material diminishes volumetric changes in the alveolar ridge produced after tooth extraction and needs of bone regeneration previous or simultaneous to implant placement compared to spontaneous healing.
Secondary objectives:
To determine if there are differences in wound healing after the use of L-PRF compared to spontaneous healing.
To investigate if there are differences in Patient Reported Outcome measures after the use of L-PRF compared to spontaneous healing.
To analyse the histologic differences in quality of bone after the use of L-PRF compared to spontaneous healing.
-Material and Methods
Randomized clinical trial developed in an academic onset, parallel groups, single-blinded with one year follow up after implant loading.
Ethical Aspects:
This investigation will be based on compliance with the principles of the Declaration of Helsinki. The ethics committee of Hospital Clínico San Carlos will be in charge of evaluating and approving this protocol. All patients will be fully informed before their inclusion in the study by means of informed consent.
Treatment:
All the participants will be treated by postgraduate students at the Master of Periodontology and Implant dentistry from the Complutense University of Madrid.
Twenty-eight patients in need of extraction will be included in the study. In the baseline visit local anesthesia will be administered and tooth extraction will be performed in the least traumatic way possible. The group will be allocated according to a computer-generated randomization list and given in a sealed envelope. For the test group (L-PRF) venipuncture (median basilica vein, median cubital vein, median cephalic vein) will be performed by a nurse and blood will be drawn into 8 sterile plastic 10 ml tubes without anticoagulant (Vacutainers: IntraSpin™, Intra-lock,USA). L-PRF plugs and membranes will be prepared as described by Choukroun et al 2001. Tubes will be centrifuged for 12 minutes at 2700 rpm using a table centrifuge (IntraSpin™, IntraLock, USA). After centrifugation, clots will be removed from the tubes, separated from red element phase at the base with pliers and placed in a metal tray (Xpression™ Box). Four to five of them will be packed in a cylinder to obtain plugs, and four will be squeezed between the tray and a glass plate to obtain L-PRF membranes. In sockets of the L-PRF group, 2-5 plugs, depending on the size of the socket will be inserted and compressed and membranes will be adapted on top and inserted in vestibular and lingual envelope flaps previously prepared. A crossed horizontal mattress suture (Polyamide 5.0, Supramid™, SMI AG, Steinerberg, Belgium) will be placed on top. In the control group, after extraction, just the suture will be performed to stabilize the coagulum. Patients will be prescribed ibuprofen (600mg t.i.d) or paracetamol (1g t.i.d) and chlorhexidine 0.12% + 0.05% CPC mouth rinse (PerioAid® Tratamiento, Dentaid, Barcelona, Spain) for one week.
Follow up visits:
After extraction, a cone-beam computed tomography (CBCT) scan (i-CAT Classic, Imaging Sciences International, Hatfield, Pennsylvania) and a digital impression (Medit i500 ™, Medit, Seoul, Korea) to obtain a stereolithographic model of the area will be taken.
Sutures will be removed at 7days. Patients will attend follow-up visits at 4 weeks and 4 months to monitor wound healing. Patient reported outcome measures (PROM's) will be registered at 1 and 4 weeks.
Diagnostic for implant placement:
Four months after tooth extraction, the new CBCT will be assessed to see bone availability for implant placement. In this visit a new digital impression will be taken to assess dimensional changes in bone and soft tissue with an image analysis software (SMOP®, Swissmeda, Switzerland).
Implant surgery will be scheduled, it will be determined if bone regeneration is necessary before or simultaneously to implant placement. At the time of implant placement, a biopsy will be taken for histologic analysis with a trephine bur of 2.5mm diameter (Komet, USA) with the aim to obtain a sample of healed bone tissue and perform histologic analysis. After osteotomy, an implant Gold \& Blue (Intralock, USA) will be inserted. If there is no need of bone regeneration, healing abutments will be placed; if there is need of simultaneous bone regeneration the width and height of the defect will be registered and a bone substitute NanoBone®(Intra-lock Iberia, Madrid Spain) and a resorbable collagen membrane (Bio-Gide; Geistlich, Switzerland will be placed, with a submerged healing protocol. Four months late, second stage surgery will be performed. If implant cannot be properly stabilized, a guided bone regeneration will be performed with the same materials and implants will be placed after six months.
After implant placement, a periapical x-ray will be performed, and sutures will be removed after one week.
Implant restoration:
After a healing period of 10 weeks after implant placement (between 4-6 months if bone regeneration has been required), impressions will be taken to make the provisional or final prosthesis, STLs models for ridge changes assessment and implant related variables will be registered.
The day of implant loading, a new standardized periapical x-ray will be taken with a personalized bite block. Peri-implant health related variables will be assessed, and esthetic outcomes will be registered. This will be the baseline visit for the follow up analysis of the implants placed.
Implants follow up:
The implants will be assessed at 6 and 12 months after loading the final prosthesis. In these visits, the same clinical variables related to peri-implant health and aesthetics will be recorded as in the baseline visit (definitive load). Additionally, at 12 months a periapical X-ray will be performed, a digital impression of the treated area will be taken and a satisfaction questionnaire will be given to the patient.
-Sample size calculation
The sample size calculation was based on detecting a mean difference in reduction of the HRW of 2,3mm with an estimated standard deviation (SD) of 1.1 between groups (Thalmair et al., 2013). To detect statistically significant differences (α=0.05) with a 90% power, a minimum of 11 subjects per group are needed, which including an expected 20% drop-out rate, it resuls in a final sample of 14 participants per group.
-Data analysis
Data will be analyzed to compare both treatment modalities. The normality of the distribution will be evaluated using the Kolmogorov-Smirnov test. Depending on the distribution of the data, parametric or non-parametric tests will be used. Quantitative variables will be assessed by means of student´s t test or Mann Whitney´s U test.
Qualitative variables will be expressed through distribution frequencies and will be compared with chi-square tests.
The clinical significance level is set at p<0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Controlled clinical trial, 2 groups of patients undergoing tooth extraction, allocated to: * Test group: alveolar ridge preservation with L-PRF * Control group: spontaneous healing of the socket
| Arm | Type | Receives |
|---|---|---|
| L-PRF | Experimental | Procedure: Tooth extraction, Procedure: Alveolar ridge preservation with L-PRFTest group, alveolar ridge preservation with L-PRF after tooth extraction. |
| Spontaneous Healing (SH) | No intervention | –Control group, spontaneous healing of the socket after tooth extraction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tooth extractionTooth extraction in the most atraumatic way | Procedure or surgery | L-PRF |
| Alveolar ridge preservation with L-PRFBlood will be drawn from the patient, centrifugued and leukocyte and platelet-rich fibrin (L-PRF) will be obtained. L-PRF plugs and membranes will be prepared and placed in the socket after extraction | Procedure or surgery | L-PRF |
Primary outcome
Radiographic linear changes in horizontal width of the alveolar ridge
Time frame: From tooth extraction (Baseline) to four months healing (4m)
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.
6 secondary outcomes
Radiographic linear changes height of the alveolar ridge
Time frame: From tooth extraction (Baseline) to four months healing (4m)
Changes in ridge contour
Time frame: From tooth extraction (Baseline) to four months healing (4m)
Volumetric changes
Time frame: From tooth extraction (Baseline) to four months healing (4m)
Patient reported outcome measures
Time frame: At one week, one month and four months visit.
Bone regeneration needs
Time frame: 4 months after tooth extraction
Percentage of mineralized bone
Time frame: 4 months after tooth extraction, during the implant placement surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2022.
- BackgroundChoukroun, J., Adda, F., Schoeffler, C., & Vervelle, A. (2001). The opportunity in perio-implantology: The PRF. Implantodontie, 42, 55-62.
- Background: PubMed 19089687Dohan 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.
- Background: PubMed 22211303Tan 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.
- Background: PubMed 18672985Barone 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.
- Background: PubMed 12956475Schropp 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.
- Background: PubMed 30246362Sanz-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.
- Background: PubMed 22211304Vignoletti 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.
- Background: PubMed 16307569Furhauser 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.
- Background: PubMed 28710793Ortiz-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.
- Results publication: PubMed 27338946Anwandter 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.2016.06.005. Epub 2016 Jun 20.
- Results publication: PubMed 27509214Temmerman 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(11):990-999. doi: 10.1111/jcpe.12612. Epub 2016 Sep 21.
- Results publication: PubMed 23647007Thalmair 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 5.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tooth extraction and Alveolar ridge preservation with L-PRF in people with Alveolar Ridge Preservation and Dental Implants, run by Universidad Complutense de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic linear changes in horizontal width of the alveolar ridge (time frame: From tooth extraction (Baseline) to four months healing (4m)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05662709, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2022.