NCT03177876

Brief Summary

twenty recruited patients indicated for sinus augmentation and immediate implant placement will be divided into two groups (10 in each of the two groups), to compare bone formation and implant stability after shneiderian membrane elevation and augmentation with Hydroxyapatite Nano particles \[Nanostreams\] or augmentation with graft less tenting technique with simultaneous implant placement.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2016

Status
unknown

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

Study Start

First participant enrolled

July 1, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2017

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 6, 2017

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

June 6, 2017

Status Verified

June 1, 2017

Enrollment Period

11 months

First QC Date

May 19, 2017

Last Update Submit

June 5, 2017

Conditions

Keywords

tenting Hydroxyapetite nano particles implant immediate

Outcome Measures

Primary Outcomes (1)

  • patient satisfaction

    evaluation of post operative complications in terms of pain and edema using patient pain chart

    7 days post operative

Secondary Outcomes (2)

  • implant stability

    will be measured intra-operative after implant insertion and will be measured one more time 6 months after the first operation at the time of implant exposure

  • height of bone gain or loss around the implant

    6 months post operative

Study Arms (2)

sinus lift implant placement Hydroxyapatite Nano particles

EXPERIMENTAL

shneiderian membrane elevation and augmentation with Hydroxyapatite Nano particles \[Nanostreams\] with simultaneous implant placement

Procedure: sinus lift implant placement Hydroxyapatite Nano particles

sinus lift implant placement tenting

ACTIVE COMPARATOR

shneiderian membrane elevation and augmentation with graft less tenting technique with simultaneous implant placement

Procedure: sinus lift implant placement tenting

Interventions

shneiderian membrane elevation and augmentation with Hydroxyapatite Nano particles with simultaneous implant placement

sinus lift implant placement Hydroxyapatite Nano particles

shneiderian membrane elevation and augmentation with graft less tenting technique with simultaneous implant placement

sinus lift implant placement tenting

Eligibility Criteria

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

You may qualify if:

  • Patients with atrophic maxilla and pneumatization of the maxillary sinus with residual bone height at least 5mm of residual ridge as per MISCH criteria
  • Both sexes

You may not qualify if:

  • Sinus pathology
  • Heavy smokers more than 20 cigarettes per day
  • Patients with systemic disease that may affect normal healing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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
Doctor

Study Record Dates

First Submitted

May 19, 2017

First Posted

June 6, 2017

Study Start

July 1, 2016

Primary Completion

June 1, 2017

Study Completion

July 1, 2017

Last Updated

June 6, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will share