Lateral Sinus Augmentation Utilizing Bovine Bone Mixed with Platelet-rich Fibrin

NCT06810921 | Completed Early Phase 1

• 1 other identifier: 998125
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Background: In sinus augmentation procedure, graft resorption remains a major dilemma of various graft materials. Objective: To estimate the graft volume changes following lateral sinus augmentation utilizing cone beam computed tomography. Methods: A total of 34 lateral sinus augmentation operations were performed and 50 dental implants were concomitantly inserted. The sinus augmentation cases were distributed randomly into 3 groups according to graft material: Group A comprised utilizing deproteinized bovine bone alone, group B using deproteinized bovine bone mixed with leukocyte and platelet-rich fibrin, and group C employing deproteinized bovine bone mixed with advanced platelet-rich fibrin. Cone-beam computed tomography was obtained 2 weeks (baseline record) and 24 weeks postoperatively for the measurement of the graft volume changes.

Conditions

Lateral Sinus Lifting

Outcome Measures

Primary Outcomes (1)

• Evaluation of graft volume changes based on CBCT imaging

  24 weeks

Study Arms (1)

utilizing bovine bone mixed with PRF for sinus lifting

ACTIVE COMPARATOR

Procedure: lateral sinus lift

Interventions

lateral sinus lift PROCEDURE

A rectangular shaped osteotomy was performed using a low-speed surgical handpiece and round diamond bur, with copious cooled normal saline irrigation. The Schneiderian membrane (SM) was gently elevatated using Frios Sinus Set elevators for implant placement

utilizing bovine bone mixed with PRF for sinus lifting

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• requiring lateral sinus lift for implant placement

You may not qualify if:

• available bone permits implant placement without need for sinus lifting

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

College of Dentistry

Bab Al Muadham, Baghdad Governorate, 10047, Iraq

Location

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer at University of Baghdad

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: February 6, 2025
• Study Start: January 13, 2023
• Primary Completion: March 20, 2024
• Study Completion: August 1, 2024
• Last Updated: February 6, 2025

Record last verified: 2025-01

Locations

IR (1)