An interventional study of L-PRF Block with DBBM and Autogenous Bone / DBBM Composite Graft in Alveolar Ridge Resorption After Extraction, Alveolar Bone Loss and Jaw, Edentulous, Partially, sponsored by Gulf Medical University. Active, not recruiting at 1 site in United Arab Emirates. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Gulf Medical University · Not applicable, Interventional, and Treatment
Brief SummaryCopy and paste the text below into the Brief Summary text box:The purpose of this randomized controlled clinical trial is to evaluate and compare the clinical, radiographic, and histological outcomes of horizontal ridge augmentation in single edentulous sites in the esthetic zone using a Leukocyte- and Platelet-Rich Fibrin (L-PRF) Block versus a composite graft of autogenous bone and deproteinized bovine bone mineral (DBBM). Following tooth loss, the alveolar ridge undergoes physiological bone resorption, particularly at the thin facial bone wall in the anterior maxilla. Adequate bone volume is required to allow dental implant placement in an ideal prosthetically driven position and to support long-term peri-implant soft tissue stability. Guided bone regeneration (GBR) using a 1:1 composite graft of autogenous bone and DBBM covered by a collagen membrane is considered an established standard technique. However, harvesting autogenous bone requires a secondary surgical donor site, which increases surgical time, patient discomfort, and surgical morbidity. The L-PRF Block combines DBBM particles with patient-derived blood concentrates rich in fibrin and growth factors, eliminating the need for autogenous bone harvesting. In this single-blind, non-inferiority clinical trial, 70 adult patients requiring horizontal ridge augmentation in the esthetic zone before implant placement will be randomly assigned (1:1 ratio) to receive either:Test Group: Horizontal ridge augmentation using an L-PRF Block (DBBM + L-PRF membranes + liquid fibrinogen) covered with a resorbable collagen membrane. Control Group: Horizontal ridge augmentation using a composite graft (1:1 ratio of autogenous bone harvested from the mandibular symphysis and DBBM) covered with a resorbable collagen membrane. Patients will undergo 3D Cone Beam Computed Tomography (CBCT) imaging before surgery ($T_0$), immediately postoperatively ($T_1$), and 6 months post-augmentation ($T_2$). At 6 months ($T_2$), bone core biopsies will be harvested during implant placement for histological and histomorphometric analysis. Primary implant stability (ISQ) will be recorded at implant placement ($T_2$), and secondary implant stability (ISQ) will be measured at abutment connection ($T_3$). Patient-reported outcomes (pain and satisfaction with esthetics/function) and buccal bone plate thickness will be evaluated 6 months after final prosthetic restoration ($T_4$). The trial aims to test whether the L-PRF Block is non-inferior to the conventional autogenous/DBBM composite graft.
Background and Biological Rationale:
Tooth extraction initiates a physiological healing cascade accompanied by significant dimensional loss of the alveolar process, with horizontal bone loss averaging 3.87 mm. In the anterior maxilla, the facial bone wall is thin (\<1 mm in up to 90% of cases) and composed primarily of tooth-dependent bundle bone, rendering it highly susceptible to post-extraction resorption. Guided bone regeneration (GBR) is widely utilized to restore horizontal ridge width prior to implant placement. The combination of autogenous bone (AB) and deproteinized bovine bone mineral (DBBM) in a 1:1 ratio provides both osteogenic cells/growth factors and an osteoconductive scaffold with low turnover, demonstrating predictable horizontal bone gains of 4 to 5 mm. However, autogenous bone collection requires a secondary surgical site (e.g., mandibular symphysis or ramus), increasing operative time, postoperative pain, and complication risk. Leukocyte- and platelet-rich fibrin (L-PRF) blocks have emerged as a biomaterial alternative that eliminates donor site harvesting. In this technique, DBBM particles are bound within a polymerized autogenous fibrin matrix enriched with blood-derived platelets, leukocytes, and growth factors (including PDGF, VEGF, TGF-beta, and BMPs). Liquid fibrinogen facilitates cohesive molding into a form-stable block that aids graft adaptation and space maintenance while promoting local angiogenesis and cell recruitment. Study Objectives and Hypothesis:
The main objective is to evaluate whether horizontal ridge augmentation using an L-PRF Block provides non-inferior horizontal bone gain compared to a conventional autogenous bone/DBBM composite graft. The primary null hypothesis ($H_0$) states that the L-PRF Block is inferior to the autogenous bone/DBBM composite graft, with a difference in horizontal bone gain exceeding the predefined non-inferiority margin of 1 mm. The alternative hypothesis ($H_1$) states that the L-PRF Block is non-inferior. Study Methodology and Timeline:Preoperative Phase ($T_0$):Clinical and periodontal assessment (FMPS $\le 20\%$, FMBS $\le 20\%$). Preoperative CBCT scan ($T_0$) to measure baseline ridge dimensions. Professional oral hygiene therapy and instruction. Surgical Augmentation Phase ($T_1$):Full-thickness mucoperiosteal flap elevation and cortical perforations (decortication) at the recipient site. Control Group: Autogenous bone harvested from the mandibular symphysis via trephine bur, mixed 1:1 with DBBM, adapted to the defect, and covered with a native collagen membrane. Test Group: Venous blood collection (red-cap and white-cap tubes) centrifuged to produce L-PRF membranes and liquid fibrinogen. Fragmented L-PRF membranes and DBBM (50:50) mixed with liquid fibrinogen to form a cohesive L-PRF Block, adapted to the defect, and covered with a resorbable collagen membrane. Primary tension-free wound closure. Immediate postoperative CBCT scan ($T_1$) for baseline augmented graft volume. Postoperative Assessment \& Healing (2 Weeks to 6 Months):Patient-reported pain intensity (VAS 0-10) and analgesic consumption recorded at Days 3 and 7. Suture removal and wound healing evaluation at 2 weeks. Implant Placement \& Biopsy Harvesting ($T_2$, 6 Months):Follow-up CBCT scan ($T_2$) to evaluate horizontal bone gain and graft dimensional stability via digital DICOM superimposition. Prior to osteotomy, a 2 mm diameter $\times$ 6 mm depth bone core biopsy harvested along the planned implant axis using a trephine bur. Biopsies processed for H\&E and Masson's Trichrome staining to quantify newly formed bone (%), residual graft material (%), and connective tissue/marrow spaces (%). Dental implant placement and measurement of primary stability using Osstell resonance frequency analysis (ISQ). Second-Stage Surgery ($T_3$, 9 Months):Implant uncovery, healing abutment connection, and measurement of secondary stability (ISQ). Restoration \& Final Evaluation ($T_4$, 15 Months / 6 Months Post-Restoration):Delivery of final implant restoration. Final CBCT scan ($T_4$) to quantify buccal bone plate thickness surrounding the implant. Evaluation of patient satisfaction with esthetics (white and pink score) and masticatory function using a VAS questionnaire
318 studies on the registry are indexed under Alveolar Bone Loss; 79 are open to participants now.
This study's planned enrollment of 70 is above the median of 25 across 269 interventional studies indexed under Alveolar Bone Loss.
Browse Alveolar Bone Loss studies →Gulf Medical University is the lead sponsor of 43 studies on the registry; 14 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Horizontal guided bone regeneration (GBR) in a single edentulous site in the esthetic zone using an L-PRF Block (a 50:50 combination of deproteinized bovine bone mineral \[DBBM\] and fragmented L-PRF membranes mixed with liquid fibrinogen) covered with a resorbable native collagen membrane prior to staged dental implant placement.
Procedure: L-PRF Block with DBBM
Horizontal guided bone regeneration (GBR) in a single edentulous site in the esthetic zone using a 1:1 composite graft of autogenous bone (harvested from the mandibular symphysis via trephine bur) and deproteinized bovine bone mineral \[DBBM\] covered with a resorbable native collagen membrane prior to staged dental implant placement.
Procedure: Autogenous Bone / DBBM Composite Graft
Horizontal guided bone regeneration (GBR) performed using an L-PRF block consisting of a 50:50 combination of deproteinized bovine bone mineral (DBBM) and fragmented L-PRF membranes mixed with liquid fibrinogen, covered with a resorbable native collagen membrane prior to staged dental implant placement.
Horizontal guided bone regeneration (GBR) performed using a 1:1 composite graft of autogenous cortical/cancellous bone (harvested from the mandibular symphysis via trephine bur) and deproteinized bovine bone mineral (DBBM), covered with a resorbable native collagen membrane prior to staged dental implant placement.
Horizontal Bone Gain
Linear horizontal ridge width gain (measured in mm) evaluated via 3D superimposition of CBCT DICOM datasets at reference levels 1 mm, 3 mm, and 5 mm apical to the alveolar crest
Time frame: Baseline ($T_0$) and 6 months post-augmentation surgery ($T_2$
Graft Dimensional Stability and Volumetric Reduction
Percentage of linear maintenance (%) and dimensional loss (%) of the augmented ridge measured by 3D CBCT DICOM superimpositions comparing immediate post-augmentation to 6 months post-augmentation.
Time frame: Immediately after augmentation ($T_1$) and 6 months post-augmentation ($T_2$)
Buccal Bone Plate Thickness
adiographic thickness of the facial bone plate (measured in mm) evaluated on CBCT scans around dental implants at the implant shoulder level (Sh0), 2 mm apical (Sh2), and 4 mm apical (Sh4).
Time frame: 6 months post-final prosthetic restoration
Implant Primary Stability
Assessment of primary stability measured via resonance frequency analysis (RFA) expressed as Implant Stability Quotient (ISQ, scale 1-100) using the Osstell device in mesiodistal and buccolingual directions at implant placement.
Time frame: At implant placement surgery ($T_2$, 6 months post-ridge augmentation)
Implant Secondary Stability
Assessment of secondary stability measured via resonance frequency analysis (RFA) expressed as Implant Stability Quotient (ISQ, scale 1-100) using the Osstell device at second-stage uncovery surgery.
Time frame: At abutment connection surgery ($T_3$, approximately 3 months post-implant placement)
Histomorphometric Bone Outcomes
Quantitative histomorphometric analysis of trephine bone core biopsies (2 mm diameter $\\times$ 6 mm depth) measuring percentages of newly formed bone (%), residual graft material (%), and connective tissue/marrow spaces (%)
Time frame: 6 months post-ridge augmentation ($T_2$)
Postoperative Pain Intensity
Patient-reported surgical site pain evaluated using a 10-cm Visual Analog Scale (VAS 0-10, where 0 = no pain and 10 = worst imaginable pain).
Time frame: Postoperative Days 3 and 7 following augmentation surgery
Postoperative Complication Rate
Incidence of surgical or healing complications, including primary wound dehiscence, graft exposure, infection, hematoma, or donor/recipient site morbidity.
Time frame: Up to 12 months post-surgery
Patient Satisfaction with Esthetic and Functional Outcomes
Patient satisfaction evaluated on a Visual Analog Scale (VAS 0-10) assessing white esthetics (crown appearance), pink esthetics (soft tissue contour), and masticatory function.
Time frame: 6 months post-final prosthetic restoration ($T_4$)
Plan to share: Undecided
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Started Sep 2026 (actual). Primary completion is estimated for Mar 2028, 18 months after the start.
Of 167 non-industry interventional studies with no phase under Alveolar Bone Loss, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 30. This study's planned 18 months is close to that.
Counting every sponsor, half of 167 studies reached it within 18 months; a quarter within 11 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Gulf Medical University