NCT06509269

Brief Summary

The aim of this study was to evaluate the effect of intraoral scanning versus desktop scanning on the retention and adaptation of maxillary denture bases in completely edentulous patients.

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 Oct 2020

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

Study Start

First participant enrolled

October 1, 2020

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 19, 2024

Completed
Last Updated

July 19, 2024

Status Verified

July 1, 2024

Enrollment Period

2.8 years

First QC Date

July 1, 2024

Last Update Submit

July 13, 2024

Conditions

Keywords

Intraoral ScanningCAD/CAM dentureDesktop Scanning

Outcome Measures

Primary Outcomes (2)

  • Retention of denture base

    Measuring tool: Digital force meter, Measuring unit: Newton (N)

    "through study completion, an average of 1 year"

  • Adaptation of denture base

    Measuring tool: Geomagic Control X software, Measuring Unit: Millimeter (mm)

    "through study completion, an average of 1 year"

Study Arms (2)

Desktop Scanning

ACTIVE COMPARATOR

Desktop scanning of Definitive Impression

Procedure: Desktop scanning

IntraOral Scanning

EXPERIMENTAL

Intraoral scanning of edentulous Jaw

Procedure: intraoral scanning

Interventions

Intraoral Scanning of edentulous Jaw

IntraOral Scanning

Desktop scanning of definitive impression

Desktop Scanning

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with well-developed ridge
  • Firm healthy mucosa
  • Free from any signs of inflammation

You may not qualify if:

  • Patients having flabby ridge
  • Decreased flow of saliva
  • Limited mouth opening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

British University in Egypt

Cairo, Shorook, Egypt

Location

Related Publications (3)

  • Osman RB, Alharbi NM. Influence of scan technology on the accuracy and speed of intraoral scanning systems for the edentulous maxilla: An in vitro study. J Prosthodont. 2023 Dec;32(9):821-828. doi: 10.1111/jopr.13633. Epub 2023 Jan 11.

    PMID: 36571837BACKGROUND
  • Lo Russo L, Caradonna G, Troiano G, Salamini A, Guida L, Ciavarella D. Three-dimensional differences between intraoral scans and conventional impressions of edentulous jaws: A clinical study. J Prosthet Dent. 2020 Feb;123(2):264-268. doi: 10.1016/j.prosdent.2019.04.004. Epub 2019 May 29.

    PMID: 31153614BACKGROUND
  • Manicone PF, De Angelis P, Rella E, Damis G, D'addona A. Patient preference and clinical working time between digital scanning and conventional impression making for implant-supported prostheses: A systematic review and meta-analysis. J Prosthet Dent. 2022 Oct;128(4):589-596. doi: 10.1016/j.prosdent.2020.11.042. Epub 2021 Mar 5.

MeSH Terms

Conditions

Jaw, Edentulous

Condition Hierarchy (Ancestors)

Jaw DiseasesMusculoskeletal DiseasesStomatognathic DiseasesMouth, EdentulousMouth DiseasesTooth Diseases

Study Officials

  • Ramy K Elashmawy, MSc

    British University In Egypt

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass.Lecturer

Study Record Dates

First Submitted

July 1, 2024

First Posted

July 19, 2024

Study Start

October 1, 2020

Primary Completion

August 1, 2023

Study Completion

October 1, 2023

Last Updated

July 19, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations