NCT06902454

Brief Summary

Ten patients with missing maxillary posterior teeth and maxillary sinus pneumatization in this study .the floor of maxillary sinus will be elevated using densah drill via surgical guide with simultaneous implant placement . patients will be received, clinically and radiologically examined, and managed at the Oral and Maxillofacial surgery Department, Faculty of Dentistry, Tanta University.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
1mo left

Started Jun 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress94%
Jun 2024Jun 2026

Study Start

First participant enrolled

June 20, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 30, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2026

Expected
Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

1.8 years

First QC Date

March 24, 2025

Last Update Submit

January 18, 2026

Conditions

Keywords

maxillary sinus floor elevationimplant placementDensah drill

Outcome Measures

Primary Outcomes (1)

  • CBCT for all patients

    Detect the amount of elevation will be measured by drawing a tangential line against the implant surface, just above the sinus floor, a measurement will be taken up to the point where the graft material will be seen covering the top of the implant apex, Detect density of bone graft

    immediate and after 4 months

Secondary Outcomes (4)

  • degree of pain evaluated clinically for all patients

    one week

  • soft tissue healing evaluated clinically for all patients

    one week

  • infection evaluated clinically for all patients

    one week

  • Evaluation of surgical site for edema

    one week

Study Arms (1)

Densah drill technique for maxillary sinus floor elevation

EXPERIMENTAL

Ten patients with missing maxillary posterior teeth and maxillary sinus pneumatization in this study .the floor of maxillary sinus will be elevated using densah drill via surgical guide with simultaneous implant placement

Device: densah drill technique

Interventions

ten patients with maxillary sinus pneumatization will be undergo sinus floor elevation using densah drill technique with implant placement

Densah drill technique for maxillary sinus floor elevation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Residual bone ridge below the sinus floor ≥ 4 mm ≤6mm.
  • Patients should have no sinus pathology detected radiographically.
  • Inter arch space≥8mm.

You may not qualify if:

  • patients with any systemic diseases that affect osseointegration rates.
  • Heavy smokers (\>14 cigarettes per day) .
  • pathological lesions in the maxillary sinus.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Tanta University

Tanta, 3111, Egypt

Location

Study Officials

  • Asmaa El Mostafa

    faculty of dentistry Tanta University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
BDS Faculty of Dentistry Tanta University

Study Record Dates

First Submitted

March 24, 2025

First Posted

March 30, 2025

Study Start

June 20, 2024

Primary Completion

April 25, 2026

Study Completion (Estimated)

June 20, 2026

Last Updated

January 21, 2026

Record last verified: 2026-01

Locations