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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Denture A with Locator ST Participants receive Denture A retained by Locator ST attachments. | Experimental | Participants receive Denture A retained by Locator ST attachments. |
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| Denture A with Locator EMI | Experimental | Participants receive Denture A retained by two Locator EMI attachments. Same outcome measures as above, allowing comparison of attachment type influence on patient-reported and clinical outcomes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | 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) | 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. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dental Medicine, Al-Azhar University, (Assiut Branch) | Asyut | Egypt |
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| ID | Term |
|---|---|
| D019217 | Tooth Attrition |
| ID | Term |
|---|---|
| D057085 | Tooth Wear |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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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
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| Oral Health-Related Quality of Life (OHIP-19 score) | 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. | 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) | 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 | 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 |