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Completed

NCT Number: NCT05831267

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

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.

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Key information

Conditions

Sinus Floor Augmentation Graftless Sinus Elevation

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Alexandria, Azarita, 00203, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. change in implant stability

    Time frame: Baseline and 6 months

    implant stability will be measures using Ostell device.

  2. change in bone density

    Time frame: Baseline and 6 months

    bone density will be measured using CBCT

  3. change in vertical bone height

    Time frame: Baseline and 6 months

    vertical bone height will be measured using CBCT

Secondary outcomes

  1. change in pain intensity

    Time frame: 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)

  2. Change in edema score

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Hams Hamed Abdelrahman

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 26, 2023
Registry last updated
Apr 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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