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Enrolling by invitation NCT07580534

Clinical Evaluation of Conventional and 3D-printed Implant-supported Overdentures Retained With New Attachment Systems

No phase Interventional Implant Supported Overdenture Wear, Occlusal

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Crossover Assignment.
Who it may be relevant to
Registry conditions: Implant Supported Overdenture, Wear, Occlusal. Basic parameters: up to 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

Randomized Crossover Clinical Trial Comparing Two Denture Designs (A and B) Retained by Two Locator Systems (ST and EMI) in Implant Overdenture Patients

Detailed description

This randomized crossover clinical trial evaluates patient-reported outcomes and clinical performance of implant overdentures (IODs) using two different denture designs (A and B) retained by two locator attachment systems: Locator ST and Locator EMI. Each participant will receive both denture designs in a crossover sequence, allowing direct within-subject comparison.

Interventions

  • Other Crossover Assignment
    Participants receive Denture A, a conventional mandibular implant overdenture, retained by two Locator ST attachments placed in the interforaminal region. Outcomes include OHIP-19, VAS satisfaction, retention force, attachment wear, periodontal parameters, and denture tooth wear resistance.

Primary outcome measures

  • Retention Force of Implant Overdentures (IODs) [Time frame: Outcome measures were assessed at four clearly defined time points: 1. Baseline (Immediately after overdenture pick up) 2. 3 month follow up 3. 6 month follow up 4. 9 month follow up These time points correspond to the evaluation of implant overdentures]
  • Denture Wear of Implant Overdentures (IODs) [Time frame: Wear was evaluated relative to the baseline measurement taken immediately after pick-up, with follow-up assessment 9-month per denture type: 1. 3 month follow up 2. 6 month follow up 3. 9 month follow up]
  • Peri-implant Soft Tissue Health (Modified Plaque Index and Modified Bleeding Index Scores) [Time frame: Assessments performed over an 18-month total follow-up period, at the following intervals: 1 - Immediately after pick-up (baseline) 2 - 3 months 3 - 6 months 4 - 9 months 5 - 12 months 6 - 15 months 7 - 18 months]
  • Crestal bone level changes [Time frame: Radiographic measurements performed over an 18-month total follow-up period, at the following intervals: 1 - Immediately after pick-up (baseline) 2 - 3 months 3 - 6 months 4 - 9 months 5 - 12 months 6 - 15 months 7 - 18 months]
  • Oral Health-Related Quality of Life (OHIP-19 score) [Time frame: OHIP-19 scores recorded three times during each 9-month denture phase: 1 -Before pick-up 2 - Immediately after pick-up 3 - At 9 months follow up]
  • Patient Satisfaction (Visual Analog Scale Score) [Time frame: VAS satisfaction scores recorded three times during each 9-month denture phase: 1 - Before pick-up 2 - Immediately after pick-up 3 - At 9 months follow up]

Eligibility criteria

Inclusion criteria

  • Completely edentulous patients
  • Non-smokers
  • Patients free from intra-oral diseases that may affect implant-overdenture prognosis
  • Patients free from systemic conditions that may influence bone resorption or implant success
  • Able and willing to comply with study visits and follow-up schedule

Exclusion criteria

  • Smokers or tobacco users
  • Presence of active oral lesions, infections, or mucosal pathology
  • Systemic diseases affecting bone metabolism (e.g., uncontrolled diabetes, osteoporosis requiring bisphosphonates)
  • History of head and neck radiation
  • Severe parafunctional habits (e.g., bruxism)
  • Inability to attend follow-up appointments or provide informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Health services research

Study locations

Egypt · 1 center
  • Faculty of Dental Medicine, Al-Azhar University, (Assiut Branch) — Asyut

Identifiers

NCT: NCT07580534 · Al-Azhar University, (Assiut B

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗