Maxillary overdenture supported by dental implants
DeviceMaxillary overdenture supported by dental implants
NCT Number: NCT07439237
* Background Patients experiencing problems with their conventional maxillary denture can benefit from implant- retained overdentures. Bar-retained implant overdentures can be supported by 4 or 6 implants, splinted by a bar. Evidence on maxillary implant overdentures has been mostly short to medium term, non-comparing or retrospective. Even more, 15-years data of comparative studies are lacking. It is important to evaluate treatment outcomes, such as implant survival, peri-implant bone changes and patient satisfaction at the long-term. * Main research question The aim of this 15-years study is to evaluate a patient group treated 15 years ago in a prospective study with a maxillary overdenture on 4 or 6 implants in an edentulous maxilla. The primary objective of the study is to analyze marginal bone level changes by radiological assessments at 15-years follow-up. Secondary objectives are implant and overdenture survival, condition of peri- implant mucosa and patients' satisfaction. * Design (including population, confounders/outcomes) The study design is an observational study of a group of patients which were treated 15 years ago with dental implants and an overdenture in the maxilla because of problems with retention and stability with their conventional denture. Outcomes: primary outcome is the change in marginal peri-implant bone level 15 years after placing the overdenture. Secondary outcome measures will be implant and overdenture survival, peri-implant mucosa health and patients' satisfaction using a questionnaire. * Expected results Stable peri-implant bone levels, high implant and overdenture survival rate and satisfied patients.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Four- and 6-implant bar-supported maxillary overdenture studies report successful short and medium-term results, indicating that these treatment modalities are comparable and favourable. However, there is considerable heterogeneity with respect to patient and treatment variables within studies reporting on maxillary overdentures in general and four versus six implants in particular, with a lack of high quality long term data as well.
The aim of the present study is to report long term results of bar-supported maxillary implant overdentures on four and six anterior implants for which various clinical surgical and prosthetic outcome measures and subjective, patient-reported parameters are described and compared. Evidence on maxillary IOD attachment systems has been mostly short to medium term, non-comparing or retrospective and therefore inconclusive. This underlines the need for studies comparing different attachment systems with a longer follow-up.
The study design is an observational study to compare treatment outcomes of fully edentulous patients with maxillary IODs, supported by four or six implants. Patients were treated 15 years ago with dental implants and an overdenture in the maxilla because of problems with retention and stability with their conventional denture. Outcomes: primary outcome is the change in marginal peri-implant bone level 15 years after placing the overdenture. Secondary outcome measures will be implant and overdenture survival, peri-implant mucosa health and patients' satisfaction using a questionnaire.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
At the time of treatment:
Exclusion criteria
at the time of treatment:
Exclusion criteria
None
Maxillary overdenture supported by dental implants
Time frame: Through study completion, an average of 15 years
Comparison between peri-implant bone level at overdenture placement and follow-up time point in millimeters measured on intraoral radiograph
Time frame: Through study completion, an average of 15 years
Percentage of implants and overdentures present at follow-up time point
Time frame: 15 years
Patient satisfaction measured on a Visual Analogue Scale. Minimum =0 (extremely dissatisfied); Maximum = 100 (extremely satisfied)
Time frame: 15 years
Plaque index from 0 to 3. Minimum = 0 (zero plaque visible); Maximum = 3 (abundant amount of plaque visible)
Time frame: 15 years
Health of peri-implant mucosa described by Gingival index from 0 to 3. Minimum = 0 (healthy mucosa); Maximum = 3 (very infected mucosa)
Time frame: 15 years
Probing depth in the peri-implant sulcus in millimeters measured with a periodontal probe
Time frame: 15 years
Bleeding in peri-implant sulcus after probing measured with a Bleeding index from 0 to 3. Minimum = 0 (no bleeding after probing); Maximum = 3 (abundance amount of bleeding after probing)
Contact information is provided by the study sponsor or research team.
University Medical Center Groningen
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07654218
Alveolar Bone Loss, Alveolar Ridge Deficiency
Porto, Portugal
View Trial DetailsNCT07657026
Atrophic Maxilla, Bone Diseases
Cairo, Cairo Governate, Egypt
View Trial DetailsNCT07258940
Atrophic Maxilla, Bone Diseases
Verona, Italy
View Trial DetailsNCT07014085
Atrophic Maxilla, Bone Diseases
View Trial Details