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

7 mei 2026 bijgewerkt door: 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

Studie Overzicht

Toestand

Aanmelden op uitnodiging

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

20

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Onderzoek naar gezondheidsdiensten
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Ander: Crossover 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.
Experimenteel: 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.
Ander: Crossover 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Retention Force of Implant Overdentures (IODs)
Tijdsspanne: 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).
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)
Tijdsspanne: 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.
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)
Tijdsspanne: 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)
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
Tijdsspanne: 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.
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
Oral Health-Related Quality of Life (OHIP-19 score)
Tijdsspanne: 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.
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)
Tijdsspanne: 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
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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Al-Azhar University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 juni 2024

Primaire voltooiing (Geschat)

1 juni 2026

Studie voltooiing (Geschat)

1 augustus 2026

Studieregistratiedata

Eerst ingediend

25 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

7 mei 2026

Eerst geplaatst (Werkelijk)

12 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

12 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

7 mei 2026

Laatst geverifieerd

1 april 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • Al-Azhar University, (Assiut B

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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