NCT06446687

Brief Summary

This study aims to evaluate the quantity and quality of the native and the newly bone around dental implants that's simultaneously installed with sinus lifting

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

May 13, 2024

Completed
19 days until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 6, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

June 6, 2024

Status Verified

June 1, 2024

Enrollment Period

4 months

First QC Date

May 13, 2024

Last Update Submit

June 1, 2024

Conditions

Keywords

Closed Sinus liftingBone Gain

Outcome Measures

Primary Outcomes (1)

  • Cone beam computed tomography (CBCT) bone height formation around dental implants

    Calculate bone height and formation around dental implants.

    Patients will be evaluated after 3 days and weekly for the first month and then once monthly up to 4 months for signs of dehiscence. then cone-beam computed tomography 4 months postoperatively to calculate the amount of vertical bone gain.

Secondary Outcomes (1)

  • Cone beam computed tomography (CBCT) density formation around dental implants

    Patients will be evaluated after 3 days and weekly for the first month and then once monthly up to 4 months for signs of dehiscence. then cone-beam computed tomography 4 months postoperatively to calculate the amount of vertical bone gain.

Study Arms (1)

Sinus Lifting by Using Crestal approach with membrane control technique.

EXPERIMENTAL

Sinus Lifting with simultaneously implant placement.

Procedure: Dental implant with sinus lifting.

Interventions

Surgery will be performed under local infiltration anaesthesia. Flap will be done. For maxillary sinus lifting by using Crestal approach with Membrane Control Technique by Wang (Wang, 2017) will be employed. After reflecting on the flap, Magic Split will be used to confirm bone quality clinically. This will be followed by site preparation using Magic Marking Drill. Bone drilling will then be performed by Magic Drill shorter by 2 mm from the sinus floor. This will be followed by sinus lifting by using Magic Sinus Lifter (MSL). The 3mm space of the apex of the Sinus Lifter instrument enables direct control of the bone-block and consequently the membrane, which is connected to the bone-block. the fixture will be installed in the conventional method. Then cover the fixture with the cover screw. The flap will be sutured. An immediate CBCT will be requested to ensure the implant is in its proper position.

Sinus Lifting by Using Crestal approach with membrane control technique.

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients required dental implant treatment in the posterior maxilla, in the premolar and molar regions ( both sexes).
  • Residual bone height 4-8mm in the estimated implant positions.
  • The bone width of the alveolar ridge is at least 5mm in estimated implant positions.
  • The edentulous ridges are covered with optimal thickness of mucoperiosteum.

You may not qualify if:

  • Patients with a systemically diseases or inflammation whether local or generalized.
  • Patients with bleeding disorders.
  • Subjected to irradiation in the head and neck area less than 1 year before implantation.
  • Poor oral hygiene and motivation.
  • Pregnant or nursing.
  • Severe bruxism or clenching.
  • Active infection or severe inflammation in the area intended for implant placement.
  • Unable to open mouth sufficiently to accommodate the surgical tooling.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Retrognathia

Interventions

Dental Implants

Condition Hierarchy (Ancestors)

Jaw AbnormalitiesJaw DiseasesMusculoskeletal DiseasesMaxillofacial AbnormalitiesCraniofacial AbnormalitiesMusculoskeletal AbnormalitiesStomatognathic DiseasesMandibular DiseasesStomatognathic System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Dental MaterialsBiomedical and Dental MaterialsDental ProsthesisProsthodonticsDentistryProstheses and ImplantsEquipment and SuppliesManufactured MaterialsTechnology, Industry, and Agriculture

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
Affiliation oral and maxillofacial surgery master candidate at cairo university

Study Record Dates

First Submitted

May 13, 2024

First Posted

June 6, 2024

Study Start

June 1, 2024

Primary Completion

October 1, 2024

Study Completion

February 1, 2025

Last Updated

June 6, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share