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

N/AEnrolling By InvitationNCT07580534

Al-Azhar University20 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Implant Supported Overdenture Wear, Occlusal

Interventions

Crossover AssignmentOTHER

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.

Eligibility

Sex: ALLMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

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

Asyut, Egypt

Outcomes

Primary Outcomes

Retention Force of Implant Overdentures (IODs)

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).

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)

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

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)

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)

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

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.

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

Data from ClinicalTrials.gov

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