Implant Supported Overdenture, Wear, Occlusal
Conditions
Keywords
Implant overdentures (IODs), Denture wear, Peri-implant soft tissue health, Crossover clinical trial, Prosthodontic outcomes, attachment system
Brief summary
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
OTHERCrossover 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.
Sponsors
Al-Azhar University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
This randomized crossover clinical trial investigates the impact of two different denture designs (Denture A and Denture B) retained by two locator attachment systems (Locator ST and Locator EMI) in patients rehabilitated with mandibular implant overdentures (IODs). The study aims to evaluate both clinical performance and patient-reported outcomes, providing a comprehensive assessment of treatment effectiveness. Each participant receives both denture designs in a crossover sequence, allowing direct within-subject comparison and minimizing inter-patient variability. The locator systems (ST and EMI) are tested with each denture design to determine whether attachment type influences patient satisfaction, prosthesis function, and oral health-related quality of life. Primary outcomes are measured using the Arabic version of the Oral Health Impact Profile-19 (OHIP-19) and Visual Analog Scales (VAS) for satisfaction domains (comfort, chewing ability, speech clarity, esthetics, and retention
Eligibility
Sex/Gender
ALL
Age
No minimum to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention Force of Implant Overdentures (IODs) | 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). |
| Denture Wear of Implant Overdentures (IODs) | 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. |
| Peri-implant Soft Tissue Health (Modified Plaque Index and Modified Bleeding Index Scores) | 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) |
| Crestal bone level changes | 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. |
| Oral Health-Related Quality of Life (OHIP-19 score) | 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. |
| Patient Satisfaction (Visual Analog Scale Score) | 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 |
Countries
Egypt
Outcome results
None listed