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Evaluation of Bone Height Gain Following Trans-crestal Sinus Floor Elevation

Primary Purpose

Maxillary Sinus Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Densah bur
Sponsored by
Ahmed Mohamed Said Rozeik
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Maxillary Sinus Disease

Eligibility Criteria

23 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ● Patients having one missing upper posterior tooth with residual bone height beneath maxillary sinus from 5-8 mm.

    • A minimum of 6 mm residual bone width at site of implant placement.
    • The recipient site of the implant should be free from any pathological conditions.
    • No diagnosed bone disease or medication known to affect bone metabolism.
    • Patients who are cooperative, motivated and hygiene conscious.
    • Patients having adequate inter-occlusal space of 8-10 mm

Exclusion Criteria:

  • ● Systemic conditions/diseases that contraindicate surgery.

    • Radiation therapy in the head and neck region or chemotherapy during the 12 months prior to surgery.
    • Patients who have any habits that might jeopardize the osseointegration process, such as current smokers.
    • Patients with parafunctional habits that produce overload on implant, such as bruxism and clenching.
    • Patients that have any pathology in the maxillary sinuses.

Sites / Locations

  • Cairo University
  • Faculty of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Densah bur

Ostetome

Arm Description

According to the protocol for densah burs. The direction was reversed and the cutting speed was raised to 1200 rpm after the initial perforation close to the sinus floor. After that, two densifying burs were used in succession to elevate the sinus membrane by 2 mm and prepare the implant hole to the desired implant size.

Flat end osteotome of appropriate size will be introduced through the osteotomy to infracture the floor of the sinus by light malleting.

Outcomes

Primary Outcome Measures

Bone gain height
It will be measured using Cone beam computed tomography (CBCT) in mm

Secondary Outcome Measures

Full Information

First Posted
May 20, 2022
Last Updated
June 6, 2022
Sponsor
Ahmed Mohamed Said Rozeik
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1. Study Identification

Unique Protocol Identification Number
NCT05411510
Brief Title
Evaluation of Bone Height Gain Following Trans-crestal Sinus Floor Elevation
Official Title
Evaluation of Bone Height Gain Following Trans-crestal Sinus Floor Elevation Using the Densifying Bur in Comparison to The Conventional Osteotome In Patients With Atrophic Posterior Maxillae: A Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 20, 2022 (Anticipated)
Primary Completion Date
February 20, 2023 (Anticipated)
Study Completion Date
December 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ahmed Mohamed Said Rozeik

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Missing teeth usually result in functional and cosmetic deficits. Traditionally, they have been restored with dentures or fixed bridges. However, dental implants represent an excellent alternative which rely on the maintenance of a direct structural and functional connection between living bone and implant surface, which is termed osseointergration . When sufficient bone is available in maxilla, implant rehabilitation has shown high success rates of 84-92 %. Atrophy of the alveolar crest and pneumatization of the maxillary sinus limits the quality and quantity of residual bone, therefore complicating the placement of implants in the posterior maxillary area.
Detailed Description
Among the techniques used to overcome low vertical bone height in the maxilla is maxillary sinus floor augmentation. It can be performed either through a lateral window, or via a crestal access. Many long term studies and systematic reviews have showed that osteotome mediated sinus floor elevation (OSFE) technique is a highly predictable method for rehabilitation of patients with atrophied posterior maxilla with survival rates ranging from 92 % to 100 %. However, endoscopic studies have demonstrated the risk of membrane perforation while performing transalveolar sinus floor elevation. Moreover, the Summers technique can cause some complications as headache and paroxysmal positional vertigo. Additionally, the activity of osteotomes during the application of malleting pressure is difficult to control, resulting in unwanted instrument and/or graft penetration into the sinus cavity, potentially causing membrane penetration. However, Huwais invented a new technology termed osseodensification for enhancing implant primary stability in 2015. This technology is performed with the use of specially developed drill bits (Densah burs) that combine the benefits of osteotomes with tactile control during the expansion. They have four or more lands with a negative rake angle, which prevents the bur's edges from cutting the bone and so compacts it smoothly. These drills have a tapered shank and a cutting chisel edge. They can thus go deeper into the osteotomy site, while the drill's gradually increasing diameter aids in the site's gradual enlargement. Drills are utilized to enter into the bone in a clockwise rotation (Cutting mode) until the appropriate depth of the osteotomy is reached. Afterwards, counterclockwise rotations (Densifying mode) generate a robust and dense layer of bone tissue along the osteotomy's walls and base. Through controlled deformation, this procedure burnishes bone along the inner layer of the osteotomy site. The goal is to construct a condensed layer of autografted bone along the implant's periphery and apex. This would improve the bone-implant contact, hence increasing insertion torque values and, as a result, implant primary stability.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maxillary Sinus Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Densah bur
Arm Type
Experimental
Arm Description
According to the protocol for densah burs. The direction was reversed and the cutting speed was raised to 1200 rpm after the initial perforation close to the sinus floor. After that, two densifying burs were used in succession to elevate the sinus membrane by 2 mm and prepare the implant hole to the desired implant size.
Arm Title
Ostetome
Arm Type
Active Comparator
Arm Description
Flat end osteotome of appropriate size will be introduced through the osteotomy to infracture the floor of the sinus by light malleting.
Intervention Type
Procedure
Intervention Name(s)
Densah bur
Other Intervention Name(s)
Densifying bur
Intervention Description
Surgical treatment
Primary Outcome Measure Information:
Title
Bone gain height
Description
It will be measured using Cone beam computed tomography (CBCT) in mm
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
23 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ● Patients having one missing upper posterior tooth with residual bone height beneath maxillary sinus from 5-8 mm. A minimum of 6 mm residual bone width at site of implant placement. The recipient site of the implant should be free from any pathological conditions. No diagnosed bone disease or medication known to affect bone metabolism. Patients who are cooperative, motivated and hygiene conscious. Patients having adequate inter-occlusal space of 8-10 mm Exclusion Criteria: ● Systemic conditions/diseases that contraindicate surgery. Radiation therapy in the head and neck region or chemotherapy during the 12 months prior to surgery. Patients who have any habits that might jeopardize the osseointegration process, such as current smokers. Patients with parafunctional habits that produce overload on implant, such as bruxism and clenching. Patients that have any pathology in the maxillary sinuses.
Facility Information:
Facility Name
Cairo University
City
Cairo
ZIP/Postal Code
002
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Rozeik, Master
Facility Name
Faculty of Dentistry
City
Cairo
ZIP/Postal Code
002
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Omar Ashour, PhD
Phone
01115537575
Email
a.saeed8979@gmail.com
First Name & Middle Initial & Last Name & Degree
Ahmed Rozeik, Master

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Evaluation of Bone Height Gain Following Trans-crestal Sinus Floor Elevation

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