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

NCT05831267 — Not applicable, Completed, 30 participants, Hams Hamed Abdelrahman

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT05831267
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	30 (Actual)
Sponsor	Hams Hamed Abdelrahman (Other)
Conditions	Sinus Floor Augmentation, Graftless Sinus Elevation
Interventions	Fibrin Glue, T-PRF, Negative control (Other)
Dates	start 2022-02-01, primary completion 2022-09-30, completion 2022-09-30, first posted 2023-04-26, last updated 2023-04-26
Locations	1 site in Egypt

-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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions
Study group 1	Experimental	Other: Fibrin Glue
Study group 2	Experimental	Other: T-PRF
Control group	Other	Other: Negative control

Fibrin Glue (Other): 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
T-PRF (Other): 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.
Negative control (Other): this group will not receive any material.

+Outcome measures

Primary outcomes

change in implant stability [Baseline and 6 months]: implant stability will be measures using Ostell device.
change in bone density [Baseline and 6 months]: bone density will be measured using CBCT
change in vertical bone height [Baseline and 6 months]: vertical bone height will be measured using CBCT

Secondary outcomes

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)

+Eligibility

Sex: All, ages: 20 Years to 60 Years

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.

+Locations (1)

Facility	City	Country	Status
Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt	Alexandria, Azarita	Egypt