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

Fibrin Glue Versus Titanium Platelet-rich Fibrin as a Sole Filling Material in Lateral Sinus Lifting With Simultaneous Implant Placement (Randomized Controlled Clinical Trial )

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.

Study Overview

• Status: Completed
• Conditions: Sinus Floor Augmentation; Graftless Sinus Elevation
• Intervention / Treatment: Other: Fibrin Glue; Other: T-PRF; Other: Negative control

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Azarita
    • Alexandria, Azarita, Egypt, 00203
      • Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control group	Other: Negative control; this group will not receive any material.
Experimental: Study group 1	Other: Fibrin Glue; Blood samples were collected from the antecubital vein of the right or left arm of the patient and drawn into sterile Titanium tubes immediately. The tubes were then centrifuged for 12 minutes at 2800 rpm and room temperature
Experimental: Study group 2	Other: T-PRF; The contents of the two containers (human fibrinogen, human thrombin) will be mixed with distilled water and then aspirated by two syringes after that, the two solutions will be mixed together and injected into the empty compartment around the dental implant under the sinus mucosal lining using auto mixing applicator.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in implant stability	implant stability will be measures using Ostell device.	Baseline and 6 months
change in bone density	bone density will be measured using CBCT	Baseline and 6 months
change in vertical bone height	vertical bone height will be measured using CBCT	Baseline and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in pain intensity	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)	Through 1 week postopertaive
Change in edema score	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)	Through 1 week postopertaive

Collaborators and Investigators

• Sponsor: Hams Hamed Abdelrahman

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: April 14, 2023
• First Submitted That Met QC Criteria: April 14, 2023
• First Posted (Actual): April 26, 2023

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 14, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Fibrin glue; Tenting implant; T-PRF
• Additional Relevant MeSH Terms: Hemostatics; Coagulants; Fibrin Tissue Adhesive
• Other Study ID Numbers: Sinus_lifting_2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No