Clinical trial NCT06686836: Efficacy of L-PRF Against Deproteinized Bovine Mineralized Bone (DBBM)
Official title: Efficacy of Platelet- and Leukocyte-rich Fibrin (L-PRF) in Reducing Healing Time in Sinus Lift Combined with Deproteinized Bovine Mineralized Bone (DBBM): Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Patients with Posterior Maxillary Atrophy and Need for Sinus Lift Surgery to Allow Implant Placement
Keywords: Posterior maxillary atrophy; Dental implants; Sinus lift; Bone grafting; Platelet-rich fibrin; Alveolar ridge augmentation; Bone regeneration; Bone substitutes
Lead sponsor: University of Santiago de Compostela
Sponsor class: OTHER
Collaborators: name: Straumanngroup
name: Geistlich Pharma AG
First posted: 2024-11-13
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study compared two groups: one receiving DBBM alone (control) and the other receiving a combination of DBBM and an L-PRF block (test group).
Primary purpose: TREATMENT

Brief summary: Objective: The main objective of this study is to evaluate whether the use of L-PRF combined with deproteinized bovine mineralized bone (DBBM; BioOss, Geistlich Pharma®) reduces healing time, through histomorphometric analysis using bone biopsies after maxillary sinus elevation versus the use of deproteinized bovine mineralized bone (DBBM) alone.

Materials and methods: 24 patients with posterior maxillary atrophy (residual bone height \<5mm without need for vertical regeneration) and need for sinus lift surgery to allow implant placement were treated ,12 DBBM (control group) 12 L-PRF block (Test group). At 4 months after sinus lift, a biopsy was taken and implants were placed with submerged healing. After 6 months, the second surgical phase was performed and another biopsy was taken. The bone samples collected were analyzed histologically and histomorphometrically. Patients received prosthetic restorations after 9 months and were followed up at 12 months. Volumetric changes were analyzed at 4 and 12 months.

Detailed description: The study was a double-blind randomized controlled clinical trial (RCT), with a parallel design. Patients requiring an open sinus lift procedure before implant placement.

For the procedure it was use two types of filler, L-PRF block (test group) and DBBM alone (control group).

All patients were randomized and assigned to each of the study groups through a computer-generated randomization.

The primary outcome was percentage of new bone formed after treatment by histological and histomorphometric measurement of biopsies (%NeoformedBone=(Regenerated bone/total area)x100) at 4 and 6 months.

Eligibility criteria: Inclusion Criteria:

* Patients \>18 years
* Presence of oral health (periodontally healthy or periodontitis treated), with a BoP \<20% and PI \<20%.
* Systemically healthy, with no disease that might contraindicate oral surgery.
* Non-smokers or smokers of \<10 cig/day.
* Need to place implants in postero-superior sector with a residual bone height of \< 5mm (no need for vertical regeneration).
* More than 3 months since tooth extraction in the treatment area.
* Absence of sinus pathology.

Exclusion Criteria:

* Patients who, due to systemic conditions, blood extraction is not possible.
* Medication that may interfere with bone metabolism (e.g. corticosteroids, bisphosphonates).
* History of radiotherapy.
* Pregnant and/or breastfeeding women.

Primary outcomes:
measure: Percentage of new bone formed
timeFrame: 4 and 6 months after treatment
Secondary outcomes:
measure: Percentage of remaining material (%)
timeFrame: 4 and 6 months after treatment
measure: Volumetric changes of regenerated bone
timeFrame: baseline, 4 and 12 months after treatment
measure: Implant stability
timeFrame: 4 and 6 months after treatment
measure: Implant success
timeFrame: 12 months after treatment
Other outcomes:
Locations:
city: Santiago de Compostela
country: Spain
facility: Department of periodontology, Faculty of Dentistry, University of Santiago de Compostela
Study officials:
References: