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NCT Number: NCT07208812

3D-Printed Implant Overdentures: Comparing Impression Techniques

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

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Key information

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Mansoura University

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location status: Recruiting

Location contact

Shimaa E Aboelenin

CONTACT

[email protected]

01113786860

About this study

Edentulism has a significant impact on oral function and quality of life. The use of mandibular implant overdentures supported by two implants is widely considered the minimum standard of care, providing improved stability, function, and patient satisfaction compared with conventional complete dentures. Recently, digital workflows and additive manufacturing (3D printing) have created new opportunities for fabricating complete dentures with improved efficiency and reduced costs.

Several impression techniques are currently available for implant-retained overdentures, but there is limited evidence on how these techniques influence functional outcomes and patient-reported satisfaction, particularly when using 3D-printed prostheses.

This randomized crossover clinical trial will be conducted at the Faculty of Dentistry, Mansoura University. Sixteen completely edentulous patients aged 45-70 years will receive two implants placed in the mandibular canine region. After the osseointegration period, each participant will be provided with three different mandibular implant overdentures fabricated using different impression techniques:

  • Conventional open-tray implant-level impression
  • Functionally generated reline impression
  • Mucostatic base with functional borders impression Each overdenture will be worn for a period of three months, with a two-week washout period using a provisional denture before switching to the next overdenture. Randomization will determine the sequence of interventions for each patient.

The primary outcome is masticatory efficiency, measured with a color-mixing ability test at 3, 6, and 9 months. The secondary outcome is patient satisfaction, measured using a Visual Analog Scale (VAS) at the same intervals.

The study is designed to provide evidence on whether the choice of impression technique affects clinical and patient-centered outcomes in 3D-printed mandibular implant overdentures.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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

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

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

Primary outcomes

  1. Masticatory efficiency

    Time frame: 3, 6, and 9 months after overdenture insertion

    Assessment of chewing efficiency using a color- mixing ability test

Secondary outcomes

  1. Patient satisfaction

    Time frame: 3, 6, and 9 months after overdenture insertion

    Patient- reported satisfaction measured using the Visual Analog Scale

Study contacts

Contact information is provided by the study sponsor or research team.

Shimaa E Aboelenin

CONTACT

[email protected]

01113786860

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Impact of Impression Techniques on Patient Satisfaction and Chewing Efficiency in 3D-Printed Implant Overdentures: A Crossover Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Oct 6, 2025
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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