Health Condition 1: K081- Complete loss of teeth
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: -Fully edentulous patients encountering problems (functional, esthetic) with existing dentures in the upper and lower jaw or patients seeking for implant-supported prostheses -Adequate bone in the anterior mandible for the placement of implants in the canine region -Ability to understand the procedure and to answer a questionnaire
Exclusion criteria
Exclusion criteria: -Impaired cognitive function and/or manual dexterity -Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant -Unable to attend follow-up examinations -Known or suspected non-compliance, drug or alcohol abuse -Presence of any uncontrolled systematic disease that could compromise implant surgery -History of radiotherapy in the head and neck region -Heavy smoker ( >20 cig./day)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To test whether or not the ADLC system results in superior VAS scores in terms of retention compared to the LOC system after 6 months applying a cross-over design.Timepoint: T0: Baseline (1 week after insertion of denture) T1: 1 month following insertion of denture T2: 3 months following insertion of denture T3: 6 months following insertion of denture | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient-reported outcome measures (PROMs) Stability of the prosthesis, maintenance of oral hygiene, ability to speak, comfort and esthetics be evaluated using VAS scores. Assessment using OHIP-14 questionnaire. Cost effective analysis for both the attachment system. Technical outcomes Timepoint: T0: Baseline (1 week after insertion of denture) T1: 1 month following insertion of denture T2: 3 months following insertion of denture T3: 6 months following insertion of denture T4: 1 year following insertion of denture T5: 3 years following insertion of denture T6: 5 years following insertion of denture | — |
Countries
India
Contacts
M.A. Rangoonwala College of Dental Sciences and Research Centre