NCT06360263

Brief Summary

Aim of the current study is to evaluate clinically and radiographically transcrestal sinus lifting with densah burs with the use of activated plasma albumin gel associated with simultaneous implant placement.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2023

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

July 10, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 8, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 11, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2024

Completed
Last Updated

January 31, 2025

Status Verified

January 1, 2025

Enrollment Period

1 year

First QC Date

April 8, 2024

Last Update Submit

January 29, 2025

Conditions

Bone Loss, Alveolar

Keywords

transcrestal sinus lifting

Outcome Measures

Primary Outcomes (4)

  • Postoperative pain

    This will be assessed using a 10-point Visual Analogue Scale (VAS). (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe)

    up to one week

  • Implant stability

    Resonance frequency analysis is based on determining whether or not an implant is stable enough. The result is presented as an ISQ value of 1-100. The higher the ISQ, the more stable the implant.

    up to 6 months

  • Vertical bone height gain

    To determine the amount of bone height gain, cone beam computed tomography (CBCT) scans will be taken immediately and after 6 months. Amount of bone height gain will be measured linearly in millimeter by determine the difference between residual bone height and bone height above the implant immediately and 6 months postoperatively in anteroposterior and mediolateral dimensions.

    up to 6 months

  • Bone density around implant

    This will be measured from CBCT scans in grayscale using a software. Densitometric analysis will be performed around dental implants on CBCT image using the software supplied with the machine. This analysis gives the actual bone density around the immersed dental implant that proves the process of osseointegration. Higher values indicate better results

    up to 6 months

Study Arms (1)

Sinus lifting using densah bur in combination with activated plasma albumin gel

EXPERIMENTAL
Combination Product: Densah bur in combination with activated plasma albumin gel

Interventions

Densah bur in combination with activated plasma albumin gelCOMBINATION_PRODUCT

Simultaneous implant placement after transcrestal maxillary sinus lifting using densah burs in combination with activated plasma albumin gel.(APAG). A full mucoperiosteal flap will be elevated, and then reflected with periosteal elevator application of first densah bur (the narrowest) with densifying mood (reverse) counterclockwise, 800-1500 revolutions per minute with copious irrigation until the sinus is reached confirm bur position with a radiograph. Then a wider densah bur (3.0) is used with the same mode and bouncing motion to elevate the sinus floor up to 3 mm in 1mm increments.The sequential densah bur will be used with the same mode and bouncing motion to elevate the the sinus floor 3 mm maximum. After achieving the final planned osteotomy diameter, the osteotomy will be filled with APAG. Then, the desired implant length is inserted.

Sinus lifting using densah bur in combination with activated plasma albumin gel

Eligibility Criteria

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

You may qualify if:

  • Patient with missing maxillary premolars and molars.
  • Vertical bone height of 3-5 mm.
  • Good oral hygiene.
  • Non smokers.

You may not qualify if:

  • Bad oral hygiene.
  • Presence of infection or periapical lesions in adjacent teeth.
  • Acute maxillary sinusitis.
  • Bruxism or clenching.
  • Medically compromised patients with a condition that affects the procedure (patients with bone diseases such as osteogenesis imperfecta and polyarthritis and patients on radiotherapy and chemotherapy)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, Egypt

Location

Related Publications (1)

  • Kamal ES, Shaaban A, Melek L. Osseodensification by Densah burs in combination with activated plasma albumin gel for transcrestal maxillary sinus lifting with simultaneous implant placement. Oral Maxillofac Surg. 2025 Sep 20;29(1):158. doi: 10.1007/s10006-025-01459-8.

    PMID: 40973834DERIVED

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal AtrophyPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Oral and Maxillofacial Surgery MSc Candidate

Study Record Dates

First Submitted

April 8, 2024

First Posted

April 11, 2024

Study Start

July 10, 2023

Primary Completion

July 10, 2024

Study Completion

July 10, 2024

Last Updated

January 31, 2025

Record last verified: 2025-01

Locations

EG(1)