Study Comparing OsseoSpeed™ Implants of Two Different Lengths in the Upper and Lower Posterior Jaw
7 maj 2020 uppdaterad av: Dentsply Sirona Implants and Consumables
An Open, Prospective, Randomized, Multi-center Study Comparing OsseoSpeed™ Implant 6 mm With OsseoSpeed™ Implant 11 mm in the Posterior Maxilla and Mandible. A 5-year Follow-up Study.
The purpose of this study is to see if OsseoSpeed™ implant 6 mm long is effective for rehabilitation of edentulism and if so, how it compares with OsseoSpeed™ implant 11 mm long.
The primary hypothesis is that the alteration in bone level is equal in patients randomized to 6 mm as to patients randomized to 11 mm implants.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
97
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Victoria
-
Melbourne, Victoria, Australien, 3010
- School of Dental Science, University of Melbourne
-
-
-
-
California
-
Los Angeles, California, Förenta staterna, 90089-0641
- USC School of Dentistry
-
-
Iowa
-
Iowa City, Iowa, Förenta staterna, 52242-1010
- The University of Iowa, College of Dentistry
-
-
-
-
-
Apeldoorn, Nederländerna, 7315
- Praktijk De Mondhoek
-
-
-
-
-
London, Storbritannien, SE1 9RT
- King's College London Dental Institute at Guy's King's and St Thomas' Hospitals
-
-
-
-
-
Göteborg, Sverige, SE 405 30
- Dept. of Parodontology, Göteborg University
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
20 år till 70 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Provision of informed consent
- Aged 20-70 years at enrolment
- History of edentulism in the study area of at least four months
- Neighboring tooth/teeth to the planned bridge must have natural root(s)
- Presence of natural teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned bridge.
- Deemed by the investigator to have a bone height of at least 11 mm and a bone width of minimum 6 mm
- Deemed by the investigator as likely to present an initially stable implant situation
Exclusion Criteria:
- Unlikely to be able to comply with study procedures, as judged by the investigator
- Earlier graft procedures in the study area
- Uncontrolled pathologic processes in the oral cavity
- Known or suspected current malignancy
- History of radiation therapy in the head and neck region
- History of chemotherapy within 5 years prior to surgery
- Systemic or local disease or condition that could compromise post-operative healing and/or osseointegration
- Uncontrolled diabetes mellitus
- Corticosteroids or any other medication that could influence post-operative healing and/or osseointegration
- Smoking more than 10 cigarettes/day
- Present alcohol and/or drug abuse
- Involvement in the planning and conduct of the study (applies to both Astra Tech staff and staff at the study site)
- Previous enrolment in the present study.
- Severe non-compliance to protocol as judged by the investigator and/or Astra Tech
- Simultaneous participation in another clinical study, or participation in a clinical study during the last 6 months
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Group-1, Implant length 6 mm
Subjects treated with OsseoSpeed™ implant, length: 6 mm
|
OsseoSpeed™ dental implant, length: 6 mm
|
|
Övrig: Group-2, Implant length 11 mm
Subjects treated with OsseoSpeed™ implant, length: 11 mm
|
OsseoSpeed™ dental implant, length: 11 mm
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Radiological Assessments of Marginal Bone Level Alteration
Tidsram: Evaluated from implant installation to 5 years follow-up after implant placement
|
Marginal Bone Level determined from radiographs and expressed as the difference from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant. Marginal Bone Level expressed in millimeters at the 5 year follow-up visit compared to values obtained at delivery of temporary restoration i.e. loading (baseline). Positive value = bone gain, Negative value = bone loss. |
Evaluated from implant installation to 5 years follow-up after implant placement
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Overall Implant Survival
Tidsram: Evaluated 5 years after implant placement
|
Overall implant survival, measured on implant level
|
Evaluated 5 years after implant placement
|
|
Evaluation of the Periimplant Mucosa Condition - By Assessment BoP
Tidsram: Measured at the 5-year follow-up visit after loading
|
Condition of the periimplant mucosa by assessment of Bleeding on Probing (BoP).
Presented as s count of implants that show presence of BoP.
|
Measured at the 5-year follow-up visit after loading
|
|
Evaluation of the Periimplant Mucosa Condition - By Assessment of Change in PPD
Tidsram: Evaluated at implant loading and at the 5-year follow-up visit.
|
Condition of the periimplant mucosa by assessment of change in probing pocket depth (PPD). Change in pocket depth expressed in millimeters at the 5-year follow-up visit, compared to values obtained at delivery of permanent restoration, i.e. loading (baseline). Negative value = increased pocket depth. |
Evaluated at implant loading and at the 5-year follow-up visit.
|
|
Presence of Plaque
Tidsram: Evaluated at the 5-year follow-up visit after loading.
|
Presence of plaque was evaluated at four surfaces around each study position (mesial, facial, distal and lingual). Plaque was recorded as presence or absence of plaque by visual inspection. A study position was considered as bleeding "yes" if at least one of the four surfaces around the implant showed presence of bleeding on probing. |
Evaluated at the 5-year follow-up visit after loading.
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Studierektor: Anna-Karin Lundgren, Direktor Clinical Research, Dentsply Sirona Implants, Mölndal, SWEDEN
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Gulje F, Abrahamsson I, Chen S, Stanford C, Zadeh H, Palmer R. Implants of 6 mm vs. 11 mm lengths in the posterior maxilla and mandible: a 1-year multicenter randomized controlled trial. Clin Oral Implants Res. 2013 Dec;24(12):1325-31. doi: 10.1111/clr.12001. Epub 2012 Sep 3.
- Zadeh HH, Gulje F, Palmer PJ, Abrahamsson I, Chen S, Mahallati R, Stanford CM. Marginal bone level and survival of short and standard-length implants after 3 years: An Open Multi-Center Randomized Controlled Clinical Trial. Clin Oral Implants Res. 2018 Aug;29(8):894-906. doi: 10.1111/clr.13341. Epub 2018 Jul 12.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 november 2007
Primärt slutförande (Faktisk)
1 maj 2016
Avslutad studie (Faktisk)
1 maj 2016
Studieregistreringsdatum
Först inskickad
16 oktober 2007
Först inskickad som uppfyllde QC-kriterierna
16 oktober 2007
Första postat (Uppskatta)
17 oktober 2007
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
19 maj 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
7 maj 2020
Senast verifierad
1 maj 2020
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- YA-SHO-0001
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .