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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 )

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05831267
Enrollment
30
Registered
2023-04-26
Start date
2022-02-01
Completion date
2022-09-30
Last updated
2023-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sinus Floor Augmentation, Graftless Sinus Elevation

Keywords

Tenting implant, Fibrin glue, T-PRF

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.

Interventions

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

OTHERT-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.

OTHERNegative control

this group will not receive any material.

Sponsors

Hams Hamed Abdelrahman
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
change in implant stabilityBaseline and 6 monthsimplant stability will be measures using Ostell device.
change in bone densityBaseline and 6 monthsbone density will be measured using CBCT
change in vertical bone heightBaseline and 6 monthsvertical bone height will be measured using CBCT

Secondary

MeasureTime frameDescription
change in pain intensityThrough 1 week postopertaiveThis 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 scoreThrough 1 week postopertaiveThe 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)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026