NCT06521853

Brief Summary

Comparison Between PEEK With Autogenous Bone Graft and PEEK With Xenograft in Maxillary Sinus Augmentation

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 26, 2024

Completed
Last Updated

November 19, 2024

Status Verified

November 1, 2024

Enrollment Period

1 month

First QC Date

April 17, 2024

Last Update Submit

November 16, 2024

Conditions

Maxillary Sinus

Keywords

maxillary sinus augmentation ; bone graft

Outcome Measures

Primary Outcomes (1)

  • bone height

    using CBCT in mm

    after 6 months

Secondary Outcomes (1)

  • bone quality

    after 6 months

Study Arms (2)

PEEK With Autogenous Bone Graft

EXPERIMENTAL

maxillary sinus elevation using PEEK device and placement of autogenous bone graft

Other: PEEK With Autogenous Bone Graft

PEEK With Xenograft

EXPERIMENTAL

maxillary sinus elevation using PEEK device and placement of xenograft

Other: PEEK With Xenograft

Interventions

PEEK With Autogenous Bone GraftOTHER

placement of PEEK With Autogenous Bone Graft

PEEK With Autogenous Bone Graft
PEEK With XenograftOTHER

placement of PEEK With xenograft

PEEK With Xenograft

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • posterior edentulous ridge less than 4mm in bone height

You may not qualify if:

  • insufficient oral hygiene and motivation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of dentistry Cairo university

Cairo, 14444, Egypt

Location

MeSH Terms

Interventions

polyetheretherketoneTransplantation, Heterologous

Intervention Hierarchy (Ancestors)

TransplantationSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

April 17, 2024

First Posted

July 26, 2024

Study Start

June 1, 2023

Primary Completion

July 1, 2023

Study Completion

December 31, 2023

Last Updated

November 19, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)