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

NCT ID: NCT05831267

Last Updated: 2023-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2022-09-30

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.

Conditions

Sinus Floor Augmentation; Graftless Sinus Elevation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study group 1

Group Type: EXPERIMENTAL

Fibrin Glue

Intervention Type: 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

Study group 2

Group Type: EXPERIMENTAL

T-PRF

Intervention Type: 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.

Control group

Group Type: OTHER

Negative control

Intervention Type: OTHER

this group will not receive any material.

Interventions

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

Intervention Type: 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.

Intervention Type: OTHER

Negative control

this group will not receive any material.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hams Hamed Abdelrahman

OTHER

Sponsor Role: lead

Responsible Party

Hams Hamed Abdelrahman

Assistant lecturer of DPH and Clinical statistician

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

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

Alexandria, Azarita, Egypt

Countries

Egypt

Other Identifiers

Sinus_lifting_2022

Identifier Type: -

Identifier Source: org_study_id