Clinical Evaluation of Conventional and 3D-printed Implant-supported Overdentures Retained With New Attachment Systems (IODs)
7. Mai 2026 aktualisiert von: Mohamed Moustafa, Al-Azhar University
Randomized Crossover Clinical Trial Comparing Two Denture Designs (A and B) Retained by Two Locator Systems (ST and EMI) in Implant Overdenture Patients
Studienübersicht
Status
Anmeldung auf Einladung
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Geschätzt)
20
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Asyut, Ägypten
- Faculty of Dental Medicine, Al-Azhar University, (Assiut Branch)
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Versorgungsforschung
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: Arm 1: Denture A with Locator ST Participants receive Denture A retained by Locator ST attachments.
Participants receive Denture A retained by Locator ST attachments.
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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.
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Experimental: Denture A with Locator EMI
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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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.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Retention Force of Implant Overdentures (IODs)
Zeitfenster: 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
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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).
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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
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Denture Wear of Implant Overdentures (IODs)
Zeitfenster: 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
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Denture wear assessed by measuring surface loss on occlusal surface using digital analysis.
Wear depth recorded in millimeters (mm) at each evaluation point.
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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
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Peri-implant Soft Tissue Health (Modified Plaque Index and Modified Bleeding Index Scores)
Zeitfenster: 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
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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
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Crestal bone level changes
Zeitfenster: 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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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.
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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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Oral Health-Related Quality of Life (OHIP-19 score)
Zeitfenster: 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
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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
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Patient Satisfaction (Visual Analog Scale Score)
Zeitfenster: 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
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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
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Mitarbeiter und Ermittler
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Sponsor
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
1. Juni 2024
Primärer Abschluss (Geschätzt)
1. Juni 2026
Studienabschluss (Geschätzt)
1. August 2026
Studienanmeldedaten
Zuerst eingereicht
25. April 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
7. Mai 2026
Zuerst gepostet (Tatsächlich)
12. Mai 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
12. Mai 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
7. Mai 2026
Zuletzt verifiziert
1. April 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- Al-Azhar University, (Assiut B
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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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