NCT06995547

Brief Summary

The goal of this clinical trial\] is to learn if digital pick up can affect occlusal forces on teeth in completely edentulous patients restored with digital complete overdenturs. The main question it aims to answer is: Researchers will compare digital vs functional pick-up techniques to see if it affects occlusal force. Participants will be asked to bite on digital articulating paper (occlusense).

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 Sep 2022

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

September 15, 2022

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 29, 2025

Completed
Last Updated

May 29, 2025

Status Verified

May 1, 2025

Enrollment Period

2.4 years

First QC Date

May 20, 2025

Last Update Submit

May 21, 2025

Conditions

Keywords

CAD-CAM, implant, locator attachment, occlusense.

Outcome Measures

Primary Outcomes (1)

  • occlusal force analysis

    twelve months

Study Arms (2)

functional pick up Group

ACTIVE COMPARATOR
Device: implant overdenture

digital pick up Group

ACTIVE COMPARATOR
Device: implant overdenture

Interventions

Each patient will be receive two dental implants for overdenture fixation

digital pick up Groupfunctional pick up Group

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • completely edentulous, healthy firm mucosa without any remaining roots or jaw cysts. Maxillomandibular Angel's class I relationship with sufficient restorative space (minimum of 8.5 mm measured by using putty index). Sufficient residual alveolar bone quantity and quality class 1-3

You may not qualify if:

  • Patients with systemic issues such as recent myocardial infarction, hepatic patients, bleeding disorders, autoimmune diseases like rheumatoid arthritis, hyperparathyroidism, uncontrolled diabetes mellitus, severe osteoporosis or cancer were excluded from the study. Also, patients with recent organ transplants, long-term corticosteroid use, radiotherapy, uncooperative patients with psychiatric disorders, heavy smokers, poor oral hygiene, and parafunctional habits were excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University

Al Mansurah, Mansoura, 35511, Egypt

Location

Study Officials

  • Abdallah mohamed Ibrahim, assistant professor

    Mansoura University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical demonstrator

Study Record Dates

First Submitted

May 20, 2025

First Posted

May 29, 2025

Study Start

September 15, 2022

Primary Completion

February 2, 2025

Study Completion

March 25, 2025

Last Updated

May 29, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations