3D-Printed Implant Overdentures: Comparing Impression Techniques

NCT07208812 | Recruiting

• 1 other identifier: MS.25.05.25
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized crossover clinical trial aims to compare three different impression techniques for the construction of 3d-printed mandibular implant overdentures in completely edentulous patients. Sixteen patients will receive two mandibular implants and three overdentures fabricated using:(1) conventional open-tray implant level impression (2) functionally generated reline impression, and (3)mucostatic base with functional borders impression. Each overdenture will be worn for three months with a washout period between interventions. The primary outcome is masticatory efficiency, assessed using a color -mixing ability test at 3,6, and9 months. Secondary outcome is patient satisfaction, assessed using a Visual Analog Scale (VAS) at the same intervals. the study hypothesis is that the impression technique influences both chewing efficiency and patient satisfaction

Conditions

Edentulism

Keywords

3D-Printed Implant Overdenture; Impression Techniques; Chewing Efficiency; Patient Satisfaction

Outcome Measures

Primary Outcomes (1)

• Masticatory efficiency

  Assessment of chewing efficiency using a color- mixing ability test

  3, 6, and 9 months after overdenture insertion

Secondary Outcomes (1)

• Patient satisfaction

  3, 6, and 9 months after overdenture insertion

Study Arms (3)

conventional open -tray impression

EXPERIMENTAL

Mandibular implant overdenture fabricated using the conventional open tray impression technique at the implant level.

Procedure: Conventional open -tray impression

Functionally generated reline impression

EXPERIMENTAL

Mandibular implant overdenture fabricated using functionally generated reline impression technique.

Procedure: Functionally generated reline impression

Mucostatic base with functional borders impression

EXPERIMENTAL

Mandibular implant overdenture fabricated using mucostatic base and functional borders impression technique.

Procedure: Mucostatic base with functional borders impression

Interventions

Functionally generated reline impression PROCEDURE

Interim prosthesis relieved and reline impression taken during centric closure with border molding, scanned to construct a 3D-printed implant overdenture

Functionally generated reline impression

Mucostatic base with functional borders impression PROCEDURE

Intraoral scan of edentulous arch, 3D-printed baseplates for occlusion rim, functional border molding, and digital workflow to fabricate 3D-printed implant overdenture

Mucostatic base with functional borders impression

Conventional open -tray impression PROCEDURE

Primary impression with irreversible hydrocolloid, custom tray with open window, and final impression with silicone material around impression copings to fabricate a 3D-printed implant overdenture

conventional open -tray impression

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy patients, free from systemic diseases that affect bone resorption (e.g., uncontrolled diabetes, osteoporosis)
• Residual alveolar ridges covered with healthy, firm mucosa
• Adequate mandibular bone length and width to accommodate standard implant sizes.
• Angle's Class I maxillo-mandibular relationship.

You may not qualify if:

• Absolute contraindications to implant placement (e.g., active cancer, immune system diseases)
• History of head and neck irradiation or chemotherapy within the past 3 years
• Metabolic bone diseases such as uncontrolled diabetes, osteoporosis, or hyperparathyroidism
• Parafunctional habits such as bruxism or clenching
• Smoking or alcoholism
• Any physical or medical condition that may interfere with study follow-up or implant success

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Faculty of Dentistry, Mansoura University

Al Mansurah, Dakahlia Governorate, 35516, Egypt

RECRUITING

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Shimaa E Aboelenin

  Faculty of Dentistry, Mansoura University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shimaa E Aboelenin

CONTACT

01113786860; shimaaaboelenin@mans.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical demonstrator at prosthodontics department

Study Record Dates

• First Submitted: September 27, 2025
• First Posted: October 6, 2025
• Study Start: January 6, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: January 29, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)