NCT07290322

Brief Summary

The goal of this clinical trial is to evaluate denture retention in intra-orally scanned versus extra-orally scanned digitally printed maxillary dentures in completely edentulous patients. The main question is : 1. Do intra-orally scanned dentures provide better retention compared to extra-orally scanned dentures? Researchers will compare the intra-orally scanned denture group to the extraorally scanned denture group to determine if one method leads to superior retention records. Participants will: • Receive both types of dentures (intra-orally scanned and extra-orally scanned), with a three-week wash-out period between each intervention. The study aims to provide evidence on the optimal scanning method for digitally printed maxillary dentures in edentulous patients.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
4mo left

Started Dec 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress82%
Dec 2024Sep 2026

Study Start

First participant enrolled

December 3, 2024

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

December 5, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 18, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

December 18, 2025

Status Verified

December 1, 2025

Enrollment Period

1.7 years

First QC Date

December 5, 2025

Last Update Submit

December 5, 2025

Conditions

Keywords

Intraoral scanningExtra oral scaningComplete edentulismDigitaldenture retention

Outcome Measures

Primary Outcomes (1)

  • Denture Retention

    the patient is observed for three weeks as awash_out period after each type of scan so that i can compare the denture retention across those periods

Study Arms (2)

Intra-Orally Scanned Dentures

EXPERIMENTAL

Participants in this arm will recieve maxillary dentures fabricated using intraoral scanning technology . digital impressions of the oral cavity will be captured directly using the 3 shape trios intraoral scanner, eliminating the need for conventional impression materials , these digital impressions will be used to design and 3D print the dentures , which will then be fitted and evaluated for retention .

Device: extraorally scanned methods

Extra-Orally Scanned Dentures

ACTIVE COMPARATOR

Participants in this arm will recieve maxillary dentures fabricated using extraoral scanning technology . conventional impressions of the oral cavity will first be taken using traditional impression material , these impressions will then be scanned externally using the 3Shape scanner to create digital models . these digital models will be used to design and 3D print the dentures , which will then be fitted and evaluated for retention .

Device: Intaorally scanned methods

Interventions

the intraoral scanning method involves capturing digital impressions of the oral cavity directly using the 3 shape scanner . this method eliminates the need for traditional impression material providing a more comfortable and precise imaging process , the digital impressions are the utilized to design and fabricate maxillary dentures using 3D printing technology . the intervention focuses on evaluating denture's retention

Extra-Orally Scanned Dentures

The extra-oral scanning method involves creating conventional impressions of the oral cavity using traditional impression materials. These impressions are then scanned externally using the 3Shape scanner to produce digital models. The digital models are used to design and fabricate maxillary dentures through 3D printing technology. This intervention aims to assess denture retention

Intra-Orally Scanned Dentures

Eligibility Criteria

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

You may qualify if:

  • completely edentulous patients
  • Angle's class I Skeletal relationship
  • normal facial symmetry
  • comparative patients

You may not qualify if:

  • tempromandibular disorders
  • uncontrolled diabetes
  • patients with neuromuscular disorders
  • severe psychiatric disorders
  • angle's class II and III skeletal relationship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo university

Giza, 12511, Egypt

Location

Related Publications (1)

  • 1-Comparative Accuracy of Intraoral and Extraoral Digital Scanners by MA Mansoor et al., published in the Journal of Prosthetic Dentistry in 2024. 2.The Accuracy of Intraoral Scan in Obtaining Digital Impressions of Edentulous Jaws by Y Wang et al., published in the Journal of Prosthetic Dentistry in 2024. 3.Comparison of Intraoral and Extraoral Digital Scanners: Evaluation of Surface Topography and Precision, published on ResearchGate in 2020. 4.Effect of Different Scanning Protocols on the Retention of Complete Dentures by SM Fadl et al., published in the Egyptian Dental Journal in 2023.

    RESULT

Related Links

Study Officials

  • Rehab R Abdalla

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Masters student

Study Record Dates

First Submitted

December 5, 2025

First Posted

December 18, 2025

Study Start

December 3, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

December 18, 2025

Record last verified: 2025-12

Locations