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Biphasic Material With PRF in Lateral Sinus Floor Augmentation

The Lateral Approach Maxillary Sinus Floor Augmentation Using Biphasic Material Combined With Injectable Platelet Rich Fibrin- Randomized Clinical Trial

Status
Not yet recruiting
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06071416
Enrollment
18
Registered
2023-10-06
Start date
2024-02-15
Completion date
2024-04-30
Last updated
2024-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maxillary Sinus Disease

Keywords

sinus floor augmentation, biphasic calcium phosphate, PRF

Brief summary

A lack of bone in the posterior maxilla, mainly resulting from the combination of alveolar bone resorption after tooth loss, pneumatization of the maxillary sinus, and periodontal disease, leads to increased difficulty during dental implant treatment. The classic technique for maxillary sinus floor augmentation entails the preparation of the trap door to elevate the schneiderian membrane in the lateral sinus wall. it can be done either in a single stage with simultaneous implant placement or in two stages with delayed implant placement, depending on the available residual alveolar ridge height that necessary for implant primary stability. The new compartment created between the floor of maxillary sinus and the elevated membrane was filled with either autogenous, allografts, xenograft or combination of them to maintain space for new bone formation. The disadvantages of such methods are high costs for grafting material, time consuming and high morbidity, because harvesting of bone grafts is needed.

Detailed description

Recently, a systematic review demonstrated the effectiveness of synthetic bone materials, including biphasic calcium phosphate (BCP), as substitutes for autogenous bone. BCP consists of hydroxyapatite (HA) and β-tricalcium phosphate (β-TCP). In contrast with stable HA, β-TCP is highly resorptive and is replaced by newly formed bone; therefore, the resorption rate of BCP could be influenced by the ratio of HA and β-TCP. platelet-rich fibrin (PRF) was recently introduced as additional or replacement materials in bone augmentation procedures. The use of biologic mediators with osteoinductive properties has been considered to reduce the time interval and accelerate the formation of new bone. The strengths of PRF in reducing tissue inflammation, promoting the vascularization of bone tissue, accelerating new bone formation, and improving scaffold mechanics have been reported.

Interventions

PROCEDURELateral sinus floor augmentation

maxillary sinus floor augmentation by lateral approach

DRUGBiphasic Calcium Phosphate

appliaction of BCP bone substitute

PROCEDUREInjectable platlets rich fibrin

centrifuge 10 ml of patient blood to get I-PRF that applied to the bone substitute

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

using automated sequence generation ( randomizer. org) patients will be divided into the two groups ,In sequentially numbered , opaque, sealed envelopes, participants will be enrolled and evaluated while the allocation sequence will be kept a secret from the researchers.

Intervention model description

Group I, patients undergo sinus lifting using bone substitute BCP alone. -Group II, patients who undergo sinus lifting using BCP with I-PRF.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Residual bone crest height \< 5 mm and width≥6 mm in the planned implant site. * Healed bone crest (at least 6 months elapsed from tooth loss/extraction);

Exclusion criteria

* Absolute medical contraindications to implant surgery such as uncontrolled diabetes mellitus, blood platelet disorders, serious osseous disorders, and cardiac arrhythmia; history of bone grafting in the posterior maxilla, immunocompromised patients, taking corticosteroids, taking aspirin before the procedure, positive history of chemotherapy and radiotherapy, and maxillary sinus pathologies

Design outcomes

Primary

MeasureTime frameDescription
Vertical bone gain BG6 monthsVertical bone gain (BG) 6 months after sinus augmentation in both height and density aspects by cone beam CT

Contacts

Primary ContactAlzahraa Alghriany, Lecturer
alghriany@aun.edu.eg+201203770058
Backup ContactAhmed Mortada Fikry, Associate professor
mortadafikry@hotmail.com+201005432223

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026