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NCT Number: NCT07580534

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

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

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Key information

Conditions

Implant Supported Overdenture Stomatognathic Diseases Tooth Attrition Tooth Diseases Tooth Wear Wear, Occlusal

Age range

Up to 70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dental Medicine, Al-Azhar University, (Assiut Branch)

Asyut, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Crossover Assignment

Other

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 outcomes

  1. 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

    Retention force measured using a digital force gauge to quantify the dislodgement force required to remove the overdenture from the implants. Measurements will be reported in Newtons (N).

  2. 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

    Denture wear assessed by measuring surface loss on occlusal surface using digital analysis. Wear depth recorded in millimeters (mm) at each evaluation point.

  3. 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

    Peri-implant soft tissue health assessed using the Modified Plaque Index (mPI) and Modified Bleeding Index (mBI).

    Both indices are ordinal clinical scales scored according to standard peri-implant evaluation criteria:

    mPI range: 0-3 0 = no plaque 3 = abundant plaque

    mBI range: 0-3 0 = no bleeding 3 = profuse bleeding

    Interpretation:

    Higher scores indicate worse peri-implant soft tissue health.

    Unit of Measure:

    Ordinal index scores (mPI, mBI)

  4. 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

    Crestal bone levels measured on standardized periapical radiographs taken with a paralleling technique. Bone level is defined as the distance from the implant shoulder to the first bone-to-implant contact.

  5. 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

    Oral health-related quality of life assessed using the Oral Health Impact Profile-19 (OHIP-19) questionnaire. The OHIP-19 consists of 19 items, each scored on a 5-point ordinal scale from 0 to 4:

    0 = never 4 = very often

    Minimum score: 0 Maximum score: 76 Interpretation: Higher scores indicate worse oral health-related quality of life.

  6. 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

    Patient satisfaction with the denture and attachment system measured using a 10-point Visual Analog Scale (VAS).

    Participants rated their satisfaction on a scale from 0 to 10:

    0 = completely dissatisfied 10 = completely satisfied

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Acronym: IODs

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 12, 2026
Registry last updated
May 12, 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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