NCT03712631

Brief Summary

aim Evaluation of the amount of bone gain following Ridge augmentation using tunneling technique in atrophic posterior mandibular ridges using anorganic bovine bone derived mineral mixed with particulated autogenous bone chips with collagen membrane

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
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2018

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

October 1, 2018

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

October 17, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 19, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

October 22, 2018

Status Verified

October 1, 2018

Enrollment Period

7 months

First QC Date

October 17, 2018

Last Update Submit

October 19, 2018

Conditions

Keywords

tunneling techniquecollagen membranetunnelaugmentationhorizontal ridge augmentationbone graftridge augmentationposterior mandible

Outcome Measures

Primary Outcomes (1)

  • Height and width of bone gained

    4 months

Secondary Outcomes (1)

  • Bone area percentage

    4 months

Study Arms (2)

bone without a collagen membrane

ACTIVE COMPARATOR

not covering bone with collagen membrane

Procedure: tunneling technique bone augmentation

bone with collagen membrane

EXPERIMENTAL

covering bone with collagen membrane

Procedure: tunneling technique bone augmentation

Interventions

horizontal ridge augmentation using mixture of xenograft,autogenous bone

bone with collagen membranebone without a collagen membrane

Eligibility Criteria

Age22 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • medically free,age 22:50 years, atrophic posterior mandibleClinical diagnosis of Alzheimer's Disease Must be able to swallow tablets

You may not qualify if:

  • smoking Insulin dependent diabetes Clinical diagnosis of Alzheimer's Disease Must be able to swallow tablets

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (39)

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    PMID: 15332183BACKGROUND
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Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
dr

Study Record Dates

First Submitted

October 17, 2018

First Posted

October 19, 2018

Study Start

October 1, 2018

Primary Completion

May 1, 2019

Study Completion

December 1, 2019

Last Updated

October 22, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
within 2 years