Densah Burs vs. Electrical Mallet in Closed Sinus Lifting.

NCT06180187 | Unknown

• 1 other identifier: 1222023
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Alveolar Bone Loss

Keywords

sinus lift; electrical mallet; osseodensification; bone density

Outcome Measures

Primary Outcomes (2)

• bone height gain

  Evaluate the change in bone height radiographically after closed sinus floor elevation and simultaneous implant placement .using cone beam computed tomography immediate after surgery and 6 months post operative .

  6 months follow up

• change in bone density

  Evaluate the amount of change in bone density around dental implant immediately post operative and after 6 months.

  6 months follow up

Study Arms (2)

Osseo-densification group

ACTIVE COMPARATOR

Device: Osseo-densification burs

Electrical mallet group

ACTIVE COMPARATOR

Device: Electrical mallet

Interventions

Electrical mallet 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 .

Electrical mallet group

Osseo-densification burs 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 .

Osseo-densification group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fayoum University: lead

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

abdelrahman S mostafa

CONTACT

1060641063; as3059@fayoum.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dentist

Model Details: 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

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: December 22, 2023
• Study Start: December 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: March 1, 2025
• Last Updated: December 22, 2023

Record last verified: 2023-12