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

Study Overview
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Brief Summary
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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.

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

Conditions
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Sinus Floor Augmentation, Graftless Sinus Elevation

Intervention / Treatment
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* Other: Fibrin Glue
* Other: T-PRF
* Other: Negative control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group 1<br> | Other: Fibrin Glue<br>* 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<br>|
| Experimental: Study group 2<br> | Other: T-PRF<br>* 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.<br>|
| Other: Control group<br> | Other: Negative control<br>* this group will not receive any material.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tenting implant, Fibrin glue, T-PRF