Early Loading
Proceduretwo TiZr implants on SLA surface
NCT Number: NCT03837158
H0: "Within the first year post-placement, four interforaminally placed, immediately loaded 2.4 mm narrow-diameter one-piece TiZr implants with miniaturized stud-type attachments show improved patient-reported outcome measures (PROMS) compared to two interforaminally placed, early loaded, TiZr two-piece implants with stud-type attachments to retain a mandibular overdenture."The specific aim is to compare both treatment alternatives to evaluate which one may be recommended for elderly edentulous patients.
This study is active but is not currently recruiting participants.
18 year and older
All sexes
Interventional
Not applicable
Private Practice Dr. B. Wallkamm, Langenthal, Canton of Bern, Switzerland
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
two TiZr implants on SLA surface
four TiZr implants on SLA surface
Time frame: One-year follow-up
Change from baseline questionnaires in Oral Health Related Quality of Life (OHRQoL).
Scores 0-60: higher values represent lower OHRQoL
Time frame: Follow-up (up to 365 days)
Change from baseline questionnaires
Time frame: Baseline, follow-up (up to 365 days)
Change in Denture Satisfaction higher values represent better satisfaction (0-1200mm)
Time frame: at implant loading (at 24 hours for arm B, at 6-8 weeks for arm A), at the one-year follow-up
Survival (yes/no)
Time frame: at implant loading (at 24 hours for arm B, at 6-8 weeks for arm A), at the one-year follow-up
Success according to Misch (2007) Misch criteria scores 1-4: higher values represent better success
Time frame: Baseline, follow-up (up to 365 days)
Prosthetic Survival (yes/no): is the denture still in place?
Time frame: Baseline, follow-up (up to 365 days)
Color mixing test
Time frame: at implant loading (at 24 hours for arm B, at 6-8 weeks for arm A), at the one-year follow-up
Plaque Index Scores 0-3 3= thick plaque is visible along gingival margin 2= plaque is visible along gingival margin, with or without air drying
1= following air drying, plaque is not visible but can be wiped off with an explorer 0= following air drying, plaque is not visible nor can be wiped off with an explorer
Time frame: at implant loading (at 24 hours for arm B, at 6-8 weeks for arm A), at the one-year follow-up
Bleeding Index Scores 0-3 0= Healthy gingival
Time frame: at implant loading (at 24 hours for arm B, at 6-8 weeks for arm A), at the one-year follow-up
depth measured in mm
Time frame: After surgery, after implants loading, after follow-up (up to 365 days)
Total treatment time will be collected and added. Total treatment cost will be evaluated and a ratio will be calculated. The groups will be compared on the base of this ration
Time frame: Total change and time at 1y follow-up
Cost effectiveness wil be calculated as a ratio of treatment cost in relation to change of GOHAI sum score. This will allow to evaluate how much monetary item is needed to achieve a change in GOHAI
Time frame: after implant loading (expected to be after 6 weeks on average) and at follow-up (up to 365 days)
Measurement with a hand-held digital force gauge
University of Bern
Other
Is the Stabilization of a Mandibular Overdenture Employing Four Novel One-piece Immediately Loaded TiZr Implants With Miniaturized Stud-type Attachments a Feasible Alternative to Two Two-piece Early Loaded Tissue-level Implants With Regular Stud-type Attachments?
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.
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