NCT03401554

Brief Summary

Evaluation the amount of bone height gained when using titanium mesh in closing the lateral window of the sinus compared to collagen membrane.Evaluation the quality of new bone gained when using of the titanium mesh to close the lateral window of the maxillary sinus as a new option for tenting compared to collagen membrane.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2017

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 13, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2017

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2017

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 17, 2018

Completed
Last Updated

January 17, 2018

Status Verified

January 1, 2018

Enrollment Period

6 months

First QC Date

January 6, 2018

Last Update Submit

January 16, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • bone height

    Evaluation the amount of bone height gained when using titanium mesh in closing the lateral window of the sinus compared to collagen membrane .

    6 months

Study Arms (2)

collagen membrane group

ACTIVE COMPARATOR

Sinus floor elevation with simultaneous implant placement and closure of the osteotomy with collagen membrane

Procedure: collagen membrane

titanium mesh group

EXPERIMENTAL

Sinus floor elevation with simultaneous implant placement and closure of the osteotomy with titanium mesh

Procedure: titanium mesh

Interventions

titanium meshPROCEDURE

closing the lateral window for maxillary sinus floor elevation with titanium mesh

titanium mesh group

closing the lateral window for maxillary sinus floor elevaion with collagen membrane

collagen membrane group

Eligibility Criteria

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

You may qualify if:

  • no signs of sinus pathology non or light smokers less than 20 cigarettes per day no systemic disease that may affect normal healing no pscychiatric problems no history of neoplasms or radiation therapy to the head and neck no previous bone augmentation to implant site

You may not qualify if:

  • Sinus pathology. Heavy smokers more than 20 cigarettes per day Patients with systemic disease that may affect normal healing. Psychiatric problems Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, الجيزة, Egypt

Location

MeSH Terms

Conditions

Mouth, EdentulousAtrophy

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesTooth DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Mostafa Mahmoud, Bds

    Study principal investigator

    PRINCIPAL INVESTIGATOR

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
Dentist

Study Record Dates

First Submitted

January 6, 2018

First Posted

January 17, 2018

Study Start

May 13, 2017

Primary Completion

November 22, 2017

Study Completion

December 17, 2017

Last Updated

January 17, 2018

Record last verified: 2018-01

Locations