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

NCT05411510 | Unknown DMC

• 1 other identifier: 2022
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Maxillary Sinus Disease

Outcome Measures

Primary Outcomes (1)

• Bone gain height

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

  6 months

Study Arms (2)

Densah bur

EXPERIMENTAL

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.

Procedure: Densah bur

Ostetome

ACTIVE COMPARATOR

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

Procedure: Densah bur

Interventions

Densah bur PROCEDURE

Surgical treatment

Also known as: Densifying bur

Densah bur; Ostetome

Eligibility Criteria

• Age: 23 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ● 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

You may not qualify if:

• ● 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.

Sponsors & Collaborators

• Ahmed Mohamed Said Rozeik: lead

Study Sites (2)

Cairo University

Cairo, 002, Egypt

Location

Faculty of Dentistry

Cairo, 002, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Priniciple investigator

Study Record Dates

• First Submitted: May 20, 2022
• First Posted: June 9, 2022
• Study Start: August 20, 2022
• Primary Completion: February 20, 2023
• Study Completion: December 20, 2023
• Last Updated: June 9, 2022

Record last verified: 2022-06

Locations

EG (2)