Biphasic Material With PRF in Lateral Sinus Floor Augmentation

NCT ID: NCT06071416

Last Updated: 2024-01-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-15
• Study Completion Date: 2024-04-30

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.

Conditions

Maxillary Sinus Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group 1 BCP alone

Lateral bone augmentation with biphasic calcium phosphate BCP bone substitute application

Group Type: ACTIVE_COMPARATOR

Lateral sinus floor augmentation

Intervention Type: PROCEDURE

maxillary sinus floor augmentation by lateral approach

Biphasic Calcium Phosphate

Intervention Type: DRUG

appliaction of BCP bone substitute

Group 2 BCP with I-PRF

Lateral bone augmentation with biphasic calcium phosphate BCP bone substitute application with addition of injectable platlet rich fibrin I-PRF

Group Type: ACTIVE_COMPARATOR

Lateral sinus floor augmentation

Intervention Type: PROCEDURE

maxillary sinus floor augmentation by lateral approach

Biphasic Calcium Phosphate

Intervention Type: DRUG

appliaction of BCP bone substitute

Injectable platlets rich fibrin

Intervention Type: PROCEDURE

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

Interventions

Lateral sinus floor augmentation

maxillary sinus floor augmentation by lateral approach

Intervention Type: PROCEDURE

Biphasic Calcium Phosphate

appliaction of BCP bone substitute

Intervention Type: DRUG

Injectable platlets rich fibrin

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Alzahraa Alghriany

Lecturer, Oral medicine, Periodontology and Oral diagnosis, Faculty of dentistry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Alzahraa Alghriany, Lecturer

Role: CONTACT

alghriany@aun.edu.eg

+201203770058

Ahmed Mortada Fikry, Associate professor

Role: CONTACT

mortadafikry@hotmail.com

+201005432223

Other Identifiers

PRF in sinus augmentation

Identifier Type: -

Identifier Source: org_study_id