3D-printed mandibular overdentures made with three different impression techniques

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized crossover trial at the Faculty of Dentistry, Mansoura University will enroll 16 completely edentulous adults aged 45–70 who will receive two implants in the mandibular canine region. Each participant will receive three 3D-printed mandibular overdentures fabricated from impressions taken by (1) a conventional open-tray implant-level technique, (2) a functionally generated reline technique, and (3) a mucostatic base with functional borders, wearing each prosthesis for three months with a two-week washout between phases. The primary outcome is masticatory efficiency measured by a color-mixing ability test at 3, 6, and 9 months, and patient satisfaction is a secondary outcome measured by a visual analog scale at the same intervals. Randomization determines the sequence of impressions in this crossover design to control for order effects.

Why it matters

Who can join: the full rules

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

Where it's running

• Faculty of Dentistry, Mansoura University
  Al Mansurah, Dakahlia Governorate, Egypt Recruiting

Study contacts

• Principal investigator: Shimaa E Aboelenin — Faculty of Dentistry, Mansoura University
• Study coordinator: Shimaa E Aboelenin
• Email: shimaaaboelenin@mans.edu.eg
• Phone: 01113786860

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.