Densah Burs vs. Electrical Mallet in Closed Sinus Lifting.

NCT ID: NCT06180187

Last Updated: 2023-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-31

Study Completion Date

2025-03-31

Brief Summary

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The aim of the comparative study is to evaluate the density and amount of new bone formed (bone height gain)around dental implant placed simultaneously in posterior maxilla after closed sinus floor elevation using Osseodensification burs versus electrical mallet.

Detailed Description

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Extraction of posterior teeth in the maxilla for long time without rehabilitation of the area increases the incidence of maxillary sinus pneumatization that makes maxillary sinus enlarges in volume over the residual bone of alveolar ridge.

Decreasing the height of sub\_ antral bone affects adversely on the bone density which is crucial for implant primary stability causing placement of dental implant quite challenging requiring sinus lifting procedure and bone condensation of residual ridge in addition to bone grafting

Summers technique considered the gold standard for closed sinus floor elevation using osteotome and a hand mallet to condense alveolar bone and elevate schneiderian membrane. One of drawbacks of this technique is benign paroxysmal positional vertigo due to force applied by hand mallet is not controlled.

Electrical mallet was introduced to overcome (BPPV) as it applies controlled force (daN) in short fraction of seconds(µs) with hand piece secured totally by the surgeon and have a wide variety of instruments placed on the hand piece e.g. osteotomes used in sinus floor elevation .

Controlled force of magnetic mallet decrees the risk of schneiderian membrane perforation

Osseodensification burs now show great outcomes in closed sinus lifting procedure.

Densah burs increase the density of alveolar bone which increase the primary stability of dental implants .

Aim of this study is to compare Electrical mallet with Osseodensification burs in closed sinus lifting.

Conditions

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Alveolar Bone Loss

Keywords

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sinus lift electrical mallet osseodensification bone density

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

group I (Osseo Densification group) Patients in this group will have sinus floor elevation using osseodensification burs then application of PRF membrane through the socket to protect schneiderian membrane and application of sticky bone (xeno graft and i-PRF) to augment alveolar ridge to receive dental implant

group II (electrical mallet group) Patients in this group will have sinus floor elevation using electrical mallet then application of PRF membrane through the socket to protect schneiderian membrane and application of sticky bone (xeno graft and i-PRF) to augment alveolar ridge to receive dental implant
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Osseo-densification group

Group Type ACTIVE_COMPARATOR

Osseo-densification burs

Intervention Type DEVICE

elevation of the Schneiderian membrane of maxillary sinus using osseodensification burs and place bone graft material to augment the residual alveolar ridge and then place dental implant .

Electrical mallet group

Group Type ACTIVE_COMPARATOR

Electrical mallet

Intervention Type DEVICE

elevation of the Schneiderian membrane of maxillary sinus using electrical mallet and place bone graft material to augment the residual alveolar ridge and then place dental implant .

Interventions

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Electrical mallet

elevation of the Schneiderian membrane of maxillary sinus using electrical mallet and place bone graft material to augment the residual alveolar ridge and then place dental implant .

Intervention Type DEVICE

Osseo-densification burs

elevation of the Schneiderian membrane of maxillary sinus using osseodensification burs and place bone graft material to augment the residual alveolar ridge and then place dental implant .

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* patients with partially edentulous posterior maxilla
* Residual bone height ≥ 5mm
* Oral hygiene : fair oral hygiene

Exclusion Criteria

* Smoking
* Systematic disease that affects bone remodeling (e.g. uncontrolled Diabetes mellitus or osteoporosis)
* Radiotherapy to head and neck or chemotherapy
* Chronic disease of maxillary sinus
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fayoum University

OTHER

Sponsor Role lead

Responsible Party

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Abdelrahman sayed mostafa elsayed

Dentist

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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abdelrahman S mostafa

Role: CONTACT

Phone: 1060641063

Email: [email protected]

Other Identifiers

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1222023

Identifier Type: -

Identifier Source: org_study_id