Densah Burs vs. Electrical Mallet in Closed Sinus Lifting. | NCT06180187

Studies
Densah Burs vs. Electrical Mallet in Closed Sinus Lifting.

NCT06180187

Sponsor

Fayoum University

Status

Unknown status

Last Update Posted

Dec 22, 2023Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Alveolar Bone Loss

Interventions

Electrical mallet
Osseo-densification burs

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2023Estimated

Primary Completion Date

Dec 2024Estimated

Completion Date

Mar 2025Estimated

First Submitted Date

Dec 4, 2023

First Submission Date that Met QC Criteria

Dec 12, 2023

First Posted Date

Dec 22, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 12, 2023

Last Update Posted Date

Dec 22, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Abdelrahman sayed mostafa elsayed, Dentist, Fayoum UniversityPrincipal Investigator

Lead Sponsor

Fayoum UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Osseo-densification group	Active Comparator		Device: Osseo-densification burs
Electrical mallet group	Active Comparator		Device: Electrical mallet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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 .

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
abdelrahman S mostafa	Contact	1060641063	+20	as3059@fayoum.edu.eg

Overall Officials

Not provided

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016301	Alveolar Bone Loss

Ancestor Terms

ID	Term
D001862	Bone Resorption
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D055093	Periodontal Atrophy

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

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