Biphasic Material With PRF in Lateral Sinus Floor Augmentation

NCT06071416 | Unknown Phase 1

• 1 other identifier: PRF in sinus augmentation
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Maxillary Sinus Disease

Keywords

sinus floor augmentation; biphasic calcium phosphate; PRF

Outcome Measures

Primary Outcomes (1)

• Vertical bone gain BG

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

  6 months

Study Arms (2)

Group 1 BCP alone

ACTIVE COMPARATOR

Lateral bone augmentation with biphasic calcium phosphate BCP bone substitute application

Procedure: Lateral sinus floor augmentation; Drug: Biphasic Calcium Phosphate

Group 2 BCP with I-PRF

ACTIVE COMPARATOR

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

Procedure: Lateral sinus floor augmentation; Drug: Biphasic Calcium Phosphate; Procedure: Injectable platlets rich fibrin

Interventions

Lateral sinus floor augmentation PROCEDURE

maxillary sinus floor augmentation by lateral approach

Group 1 BCP alone; Group 2 BCP with I-PRF

Biphasic Calcium Phosphate DRUG

appliaction of BCP bone substitute

Group 1 BCP alone; Group 2 BCP with I-PRF

Injectable platlets rich fibrin PROCEDURE

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

Group 2 BCP with I-PRF

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Interventions

hydroxyapatite-beta tricalcium phosphate

Central Study Contacts

Alzahraa Alghriany, Lecturer

CONTACT

+201203770058; alghriany@aun.edu.eg

Ahmed Mortada Fikry, Associate professor

CONTACT

+201005432223; mortadafikry@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, Oral medicine, Periodontology and Oral diagnosis, Faculty of dentistry

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

Study Record Dates

• First Submitted: October 1, 2023
• First Posted: October 6, 2023
• Study Start: February 15, 2024
• Primary Completion: March 15, 2024
• Study Completion: April 1, 2024
• Last Updated: January 31, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share