- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00066014
Clinical Investigation of Mandibular Implant Overdenture
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This project utilizes 30 subjects in a prospective, randomly assigned clinical study that uses a four-period, six sequence, three treatment crossover design to test the hypothesis that defined outcomes of variable implant overdenture treatments are equivalent. The project tests three overdenture treatment modalities, (1) four-implant, bar/clip-attached treatment, (2) two-implant, bar/clip-attached treatment, and (3) two-implant independently attached (O-ring) treatment. Each subject has four dental implants placed into the anterior mandible and new dentures are fabricated. After successful implant integration, subjects are randomly assigned to one of six sequences of treatment. Each treatment is followed for data collection for at least twelve months before the mandibular denture is modified to incorporate the next treatment in the sequence. Equivalence is measured in terms of prosthesis retention, stability, supporting and peri-implant tissue response, patient satisfaction/preference and treatment complications/failures.
Information from this study will assist dental practitioners during treatment planning in selecting appropriate and cost effective treatment choices. There is an inverse relationship between edentulism in the U.S. population and socioeconomic status. If less costly and simplified treatment methods are shown to provide an equivalent treatment outcome to more costly/complex methods, these simplified treatments can be used to treat a larger percentage of the edentulous population.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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Virginia
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Richmond,, Virginia, Forenede Stater, 23298
- Virginia Commonwealth University
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion:
- Adult patient;
- Male or female;
- At least one year of previous conventional complete denture treatment history;
- Willing to accept the conditions of the study and informed consent freely given;
- Ability to participate for 6 years;
- Able to understand and respond to self-reporting measurement scales used in the study;
- Minimum 20-mm interarch distance at the estimated vertical dimension of occlusion;
- Adequate bone quality;
- Adequate bone quantity to accommodate minimally four 3.75-mm diameter by 7-mm long Brånemark implants.
Exclusion:
- Administrative or physical considerations which would seriously affect the surgical procedure or construe a hindrance for a six-year involvement;
- History of drug or alcohol abuse;
- Excessive smoking (1+ pack/day);
- Uncontrolled systemic disease;
- Inability to undergo minor oral surgery because of health or personal reasons;
- Irradiated surgical site;
- Unrealistic expectations of the prosthodontic treatment outcome;
- Psychological or psychiatric conditions that could influence the subject's reaction to treatment;
- Acute or chronic TMD problems;
- pregnancy;
- Class II jaw relationship;
- Conventional dental treatment the treatment of choice.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: treatment modalities changed for comparison
All subjects experienced all treatment modalities being studied.
|
All overdenture treatment modalities were provided to each subject using a crossover design.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Comparison of implant overdenture clinical modalities using clinical measures to compare treatment outcomes
Tidsramme: 6 month and 12 month
|
6 month and 12 month
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: David R Burns, Virginia Commonwealth University
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- NIDCR-12204
- R01DE012204 (U.S. NIH-bevilling/kontrakt)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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