NCT05831267

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 14, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 26, 2023

Completed
Last Updated

April 26, 2023

Status Verified

April 1, 2023

Enrollment Period

8 months

First QC Date

April 14, 2023

Last Update Submit

April 14, 2023

Conditions

Sinus Floor AugmentationGraftless Sinus Elevation

Keywords

Tenting implantFibrin glueT-PRF

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • change in pain intensity

    Through 1 week postopertaive

  • Change in edema score

    Through 1 week postopertaive

Study Arms (3)

Study group 1

EXPERIMENTAL
Other: Fibrin Glue

Study group 2

EXPERIMENTAL
Other: T-PRF

Control group

OTHER
Other: Negative control

Interventions

Fibrin GlueOTHER

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 1
T-PRFOTHER

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.

Study group 2
Negative controlOTHER

this group will not receive any material.

Control group

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Alexandria, Azarita, 00203, Egypt

Location

MeSH Terms

Interventions

Fibrin Tissue Adhesive

Intervention Hierarchy (Ancestors)

FibrinBlood ProteinsProteinsAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant lecturer of DPH and Clinical statistician

Study Record Dates

First Submitted

April 14, 2023

First Posted

April 26, 2023

Study Start

February 1, 2022

Primary Completion

September 30, 2022

Study Completion

September 30, 2022

Last Updated

April 26, 2023

Record last verified: 2023-04

Locations

EG(1)