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Alveolar Ridge Resorption After ExtractionNCT07918950

L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation

A study testing L-PRF Block with DBBM and Autogenous Bone / DBBM Composite Graft in people with Alveolar Ridge Resorption After Extraction and Alveolar Bone Loss, run by Gulf Medical University at 1 site in United Arab Emirates.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
What is being tested?
L-PRF Block with DBBM and Autogenous Bone / DBBM Composite Graft
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteUnited Arab Emirates
Study dates
30 Sep 2026to 30 Mar 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age >= 18 years at the time of screening.
  • Presence of a single edentulous tooth gap in the maxillary or mandibular esthetic zone (incisors, canines, or premolars).
  • Presence of horizontal alveolar ridge deficiency (residual bone width < 5 mm) requiring staged guided bone regeneration (GBR) prior to dental implant placement.
  • Adequate vertical bone height for future implant placement (>= 10 mm above anatomical vital structures).
  • Intact adjacent natural teeth with stable periodontal health.
  • Good oral hygiene (Full-Mouth Plaque Index <= 20% and Full-Mouth Bleeding Index <= 20%).
  • Systemically healthy subjects (ASA physical status class I or II).
  • Provision of signed written informed consent, including agreement to undergo donor site surgery (mandibular symphysis), blood draws, sequential CBCT imaging, and a trephine bone core biopsy at implant placement.

Who cannot join

  • Uncontrolled systemic disease or condition affecting bone metabolism or wound healing (e.g., uncontrolled diabetes mellitus with HbA1c > 7%, osteoporosis, hyperparathyroidism).
  • History of head and neck radiotherapy or active malignancy.
  • Current or previous therapy with bone-altering medications (e.g., oral or intravenous bisphosphonates, denosumab, long-term systemic corticosteroids).
  • Heavy smoking habit (> 10 cigarettes/day) or active substance abuse.
  • Untreated active periodontal disease or active infection/periapical pathology at the surgical site or adjacent teeth.
  • Anatomical constraints or pathological lesions at the mandibular symphysis preventing autogenous bone harvest.
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  • Hematological disorders, severe anemia, or coagulation disorders contraindicating venous blood draw for PRF preparation or surgical procedures.
  • Pregnant or lactating females.
  • Known allergy to bovine-derived collagen, bovine bone mineral, or surgical materials used in the study.
  • Participation in another clinical trial within the past 30 days.

Trial locations and contacts

1 site in 1 country.

United Arab Emirates1 site
  • Gulf Medical University

    Ajman, Ajman Emirate, 0000

Other trials in United Arab Emirates

About this study

Official title: Clinical, Radiographic, and Histologic Outcomes of Horizontal Ridge Augmentation in Single Edentulous Sites in the Esthetic Zone Using L-PRF Block Versus an Autogenous Bone/Deproteinized Bovine Bone Mineral Composite Graft: A Randomized Controlled Clinical Trial

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.

Read the detailed description

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

Being tested
L-PRF Block with DBBM, Autogenous Bone / DBBM Composite Graft
Keywords
Horizontal Ridge Augmentation, Guided Bone Regeneration, L-PRF Block, Leukocyte- and Platelet-Rich Fibrin, Deproteinized Bovine Bone Mineral, Autogenous Bone Graft, Dental Implants, Esthetic Zone
Medical subject headings
Alveolar Bone Loss, Jaw, Edentulous, Partially

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • L-PRF Block with DBBMProcedure or surgery

    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.

  • Autogenous Bone / DBBM Composite GraftProcedure or surgery

    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.

Study groups in NCT07918950
Study groupRoleWhat they receive
L-PRF Block (Test Group)ExperimentalHorizontal 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.
Receives: Procedure: L-PRF Block with DBBM
Autogenous/DBBM Composite Graft (Control Group)Active comparatorHorizontal 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.
Receives: Procedure: Autogenous Bone / DBBM Composite Graft

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Baseline ($T_0$) and 6 months post-augmentation surgery ($T_2$

Secondary outcomes (8)
  1. 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.

    Measured: Immediately after augmentation ($T_1$) and 6 months post-augmentation ($T_2$)

  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).

    Measured: 6 months post-final prosthetic restoration

  3. 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.

    Measured: At implant placement surgery ($T_2$, 6 months post-ridge augmentation)

  4. 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.

    Measured: At abutment connection surgery ($T_3$, approximately 3 months post-implant placement)

  5. 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 (%)

    Measured: 6 months post-ridge augmentation ($T_2$)

  6. 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).

    Measured: Postoperative Days 3 and 7 following augmentation surgery

  7. Postoperative Complication Rate

    Incidence of surgical or healing complications, including primary wound dehiscence, graft exposure, infection, hematoma, or donor/recipient site morbidity.

    Measured: Up to 12 months post-surgery

  8. 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.

    Measured: 6 months post-final prosthetic restoration ($T_4$)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2026
  2. Study start30 Sep 2026
  3. Primary completion30 Mar 2028 (estimated)
  4. Study completion30 Mar 2028 (estimated)

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a single-center, single-blind, 2-arm, parallel-group, non-inferiority randomized controlled clinical trial with a 1:1 allocation ratio. Eligible participants requiring staged horizontal ridge augmentation in a single edentulous site in the esthetic zone prior to implant placement will be randomly assigned to one of two parallel groups: Test Group: Receives horizontal guided bone regeneration using an L-PRF Block (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. Control Group: Receives horizontal guided bone regeneration using a standard 1:1 composite graft of autogenous bone (harvested from the mandibular symphysis via trephine bur) and DBBM covered with a resorbable native collagen membrane. The study evaluates non-inferiority in linear horizontal bone gain at 6 months post-augmentation ($T\_2$) using a pre-specified non-inferiority margin of 1 mm.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07918950
Sponsor's protocol ID
IRB-COD-STD-355-September-2026
Status last verified
Oct 2026
First submitted
31 Oct 2026
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing L-PRF Block with DBBM and Autogenous Bone / DBBM Composite Graft in people with Alveolar Ridge Resorption After Extraction and Alveolar Bone Loss, run by Gulf Medical University at 1 site in United Arab Emirates.

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 8 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2026. 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 United Arab Emirates. 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.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

Horizontal Bone Gain (time frame: Baseline ($T_0$) and 6 months post-augmentation surgery ($T_2$). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 5 Nov 2026.

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