Mouth, Edentulous
Conditions
Brief summary
The aim of this study is to assess the influence of this particular treatment method on the patients' quality of life and masticatory function.
Detailed description
For this prospective randomized controlled clinical trial patients with edentulous mandibles and tissue supported (full) dentures were treated with 2 dental implants and locators in order to improve prosthesis stability. The LOCATOR System is comprised of three parts: The LOCATOR implant attachment (LOCATOR abutment), the LOCATOR Male and the LOCATOR Denture Cap. The abutment is inserted directly into the implant using a torque wrench, while the Denture Cap is placed into the base of the overdenture for polymerization using acrylic resin. Custom retention is achieved via LOCATOR Males - small color-coded (according to retention force) plastic inserts - which can be exchanged as needed.
Interventions
DEVICEA Locator with retention elements
Insertion of GC Pilier locator abutments with retention elements
DEVICEB Locator without retention elements
Insertion of GC Pilier locator abutments without retention elements
Sponsors
Philipps University Marburg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* age 45-80 years (male or female) * sufficient full dentures in the mandible * must be able to clean their teeth on their own * edentulous mandible with interforaminal adequate bone for insertion of implants * implantation sites free of infections and root fragments * no need for treatment of the maxillary teeth * Written Informed Consent
Exclusion criteria
* systemic diseases * mental disability that may affect the participant's ability to properly follow study instructions * oral mucosal diseases * long-term medication with steroids, bisphosphonates * known allergic reactions to dental materials * malignant tumor in the head and neck area * requirement of any concurrent radiotherapy or chemotherapy or any radiotherapy or chemotherapy within the last 10 years pregnancy or breastfeeding at study entry
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life (OHIP-G-49) | 3 months after randomization | The oral health-related quality of life is assessed by the German version of the Oral Health Impact Profile questionnaire (OHIP-G-49, Locker et al 1993) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plaque index | 3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3) | The Plaque index (Silness and Loe 1964) will be assessed and the change from baseline will be documented. |
| Probing pocket depth | 3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3) | The Probing pocket depth with bleeding on probing (6 sites of every tooth and implant) will be assessed and the change from baseline will be documented. |
| Gingival index | 3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3) | The Gingival index (Loe and Silness 1963) will be assessed and the change from baseline will be documented. |
| masticatory function | 3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3) | Video documentation of chewing a defined bolus. After chewing a defined bolus for 10 seconds comparison of reduction ratio of the bolus is documented by photography and the change from baseline will be documented. |
| Mucosal recessions | 3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3) | The mucosal recessions at implants will be assessed and the change from baseline will be documented. |
| width of keratinized gingiva/mucosa | 3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3) | The width of keratinized gingiva/mucosa will be assessed and the change from baseline will be documented. |
| intraoral photo-documentation | 3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3) | A photo-documentation (intraoral) will be done to assess the changes from baseline. |
| Gingival recessions | 3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3) | The Gingival recessions at teeth will be assessed and the change from baseline will be documented. |
Countries
Germany
Outcome results
None listed