NCT03184857

Brief Summary

Two stage sinus lifting using Nano hydroxyapatite particles \[Nanostreams\] versus Deprotenized bovine bone \[Tutogen\] : Randomized clinical trial. comparing between Height of new bone formation, Bone area percent( Histomorphometric)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 14, 2017

Completed
17 days until next milestone

Study Start

First participant enrolled

July 1, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

April 2, 2024

Status Verified

March 1, 2024

Enrollment Period

2.2 years

First QC Date

June 9, 2017

Last Update Submit

March 29, 2024

Conditions

Maxillary Sinus Augmentation

Keywords

maxillary sinusaugmentationbovine boneNano hydroxy appatite

Outcome Measures

Primary Outcomes (1)

  • histomorphometric analysis

    histomorphometric analysis to measure new bone percent formation and residual bone graft percent

    6 months

Secondary Outcomes (1)

  • new height of bone gained

    6 months

Study Arms (2)

two stage sinus lifting using bovine bone particles

ACTIVE COMPARATOR

Open maxillary sinus lifting will be done with sinus augmentation using bovine bone particles

Procedure: open maxillary sinus lifting

two sage sinus lifting using Nano HA bone particles

EXPERIMENTAL

Open maxillary sinus lifting will be done with sinus augmentation using Nano HA bone particles

Procedure: open maxillary sinus lifting

Interventions

open maxillary sinus liftingPROCEDURE

biopsy of the region 6 months later

two sage sinus lifting using Nano HA bone particlestwo stage sinus lifting using bovine bone particles

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • sinus pathology
  • heavy smokers
  • patients with systemic disease uncontrolled

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mahmoud Ahmed Nour Eldeen

Cairo, 11437, Egypt

Location

Related Publications (1)

  • Nour M, Shawky M, Abaas RA, Hakam M, Atef M. Two Stage Sinus Lifting Using Nanohydroxyapatite Particles Versus Deproteinized Bovine Bone: Randomized Clinical Trial. Clin Implant Dent Relat Res. 2025 Feb;27(1):e13410. doi: 10.1111/cid.13410. Epub 2024 Oct 31.

    PMID: 39478644DERIVED

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
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

June 9, 2017

First Posted

June 14, 2017

Study Start

July 1, 2017

Primary Completion

September 30, 2019

Study Completion

September 30, 2019

Last Updated

April 2, 2024

Record last verified: 2024-03

Locations

EG(1)