Fibrin Glue Versus Titanium Platelet-rich Fibrin in Lateral Sinus Lifting

Not Applicable

Completed

• Conditions: Graftless Sinus Elevation; Sinus Floor Augmentation
• Interventions: Other: Negative control; Other: Fibrin Glue; Other: T-PRF

• Registration Number: NCT05831267
• Lead Sponsor: Hams Hamed Abdelrahman

Brief Summary

Graftless sinus lift with simultaneous implant placement is one of the new techniques, this new technique is presented based on the physiology of intrasinus bone repair.

Schneiderian membrane is known to have an osteogenic nature, now blood clot can be considered autologous osteogenic graft material, to which osteoprogenitors can migrate, differentiate, and regenerate bone.

The aim of this study is to evaluate the effectiveness of using Fibrin glue versus Titanium platelet rich fibrin (T-PRF) as a sole filling material in lateral sinus lifting using with simultaneous implant placement in comparison to a negative control group.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-01
• Primary Completion: 2022-09-30
• Study Completion: 2022-09-30
• Status Verified: 2023-04
• Study First Submitted: 2023-04-14
• Study First Submitted QC: 2023-04-14
• Last Update Submitted: 2023-04-14
• Study First Posted: 2023-04-26
• Last Update Posted: 2023-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients requiring implant placement in the posterior maxilla.
• Tooth extractions at the implant sites were performed at least 4 months before surgery.
• Residual bone height between the alveolar bone crest and the sinus floor is 3-5 mm

Exclusion Criteria

• Maxillary sinus pathologies (sinusitis, long-standing nasal obstruction).
• Any disease-contraindicating surgery (e.g. uncontrolled diabetes).
• Heavy smokers (smoke greater than or equal 25 cigarettes daily).
• Acute oral infections.
• Untreated periodontal disease (gingival index 2 and 3).
• Poor oral hygiene ( Silness-Löe index (score 2-3) ).
• A history of radiotherapy or chemotherapy of the head and neck region.
• Pregnancy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Negative control	-
Study group 1	Fibrin Glue	-
Study group 2	T-PRF	-

Primary Outcome Measures

Name	Time	Method
change in bone density	Baseline and 6 months	bone density will be measured using CBCT
change in implant stability	Baseline and 6 months	implant stability will be measures using Ostell device.
change in vertical bone height	Baseline and 6 months	vertical bone height will be measured using CBCT

Secondary Outcome Measures

Name	Time	Method
change in pain intensity	Through 1 week postopertaive	This will be assessed using a 10-point Visual Analogue Scale (VAS) in the 1st week postoperatively.; (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe)
Change in edema score	Through 1 week postopertaive	The score will be as follows: * None (no inflammation); * Mild (intraoral swelling confined to the surgical field); * Moderate (extraoral swelling in the surgical zone); * Severe (extraoral swelling spreading beyond the surgical zone)

Trial Locations

Locations (1)

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