Titanium Prepared Platelet-rich Fibrin in Bone Regeneration in Lateral Window Maxillary Sinus Augmentation

Not Applicable

Completed

• Conditions: Sinus Lifting
• Interventions: Other: T-PRF alone; Other: T-PRF/Xenograft

• Registration Number: NCT06135077
• Lead Sponsor: Hams Hamed Abdelrahman

Brief Summary

This trial aims to evaluate the effect of the sole use of T-PRF in bone formation process as applied in maxillary sinus floor elevation in comparison to traditional T-PRF/bone graft combination.

This study is clinical trial that will include 18 patients seeking implant placement in upper posterior maxilla compromised with maxillary sinus pneumatization. Patients will be assigned into control and test groups. All the patients will undergo sinus lifting procedure through which a combination of xenograft and T-PRF was used in the control group whereas; sole T-PRF will be applied in the test group.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-11
• Primary Completion: 2023-03-21
• Study Completion: 2023-03-21
• Status Verified: 2023-11
• Study First Submitted: 2023-11-11
• Study First Submitted QC: 2023-11-11
• Last Update Submitted: 2023-11-11
• Study First Posted: 2023-11-18
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Systemically in a healthy condition.
• Residual bone height is ≤5mm in the posterior maxilla as measured with CBCT.
• Non-smokers.
• Good oral hygiene as indicated by plaque and bleeding scores

Exclusion Criteria

• Medically compromised conditions will be excluded to avoid infections or any adverse reaction related to immunity suppression.
• Acute maxillary sinusitis.
• Patients administering any antibiotics or regular anti-inflammatory drugs.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
T-PRF	T-PRF alone	-
T-PRF/xenograft	T-PRF/Xenograft	-

Primary Outcome Measures

Name	Time	Method
Change in bone denisty	up to 3 months	pre opertaive and post operative CBCT
Change in bone height	up to 3 months	pre opertaive and post operative CBCT
Change in pain level	up to 2 weeks	measuring level of pain using visual analog scale (VAS) 0-10, where 0 reading indicates no pain and 10 reading reflects the most severe pain.
Change in bone volume	up to 3 months	pre opertaive and post operative CBCT

Trial Locations

Locations (1)

Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University; 🇪🇬 Alexandria, Egypt