Digital Workflow Versus Functional Pick-up Techniques of Two- Implant Retained Mandibular Overdentures

NCT ID: NCT06995547

Last Updated: 2025-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-15
• Study Completion Date: 2025-03-25

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).

Conditions

Occlusal Analysis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

functional pick up Group

Group Type: ACTIVE_COMPARATOR

implant overdenture

Intervention Type: DEVICE

Each patient will be receive two dental implants for overdenture fixation

digital pick up Group

Group Type: ACTIVE_COMPARATOR

implant overdenture

Intervention Type: DEVICE

Each patient will be receive two dental implants for overdenture fixation

Interventions

implant overdenture

Each patient will be receive two dental implants for overdenture fixation

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Aya ebrahim elsayed elsayed elnagar

clinical demonstrator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Abdallah mohamed Ibrahim, assistant professor

Role: STUDY_CHAIR

Mansoura University

Locations

Mansoura University

Al Mansurah, Mansoura, Egypt

Countries

Egypt

Other Identifiers

M36080622

Identifier Type: -

Identifier Source: org_study_id