Not provided
Not provided
Not provided
Not provided
Difficulties concerning the recruitment of participants
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of this study is to assess the influence of this particular treatment method on the patients' quality of life and masticatory function.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A Locator with retention elements | Experimental | GC Pilier Locator abutment with retention elements: For patients in the experimental group (arm A) the connection of the full dentures to the implants will be achieved by fitting the dentures with GC Pilier Locator abutments with retention elements. |
|
| B Locator without retention elements | Active Comparator | GC Pilier Locator abutment without retention elements: For patients with the active comparator (arm B) the full dentures will get Pilier Locator abutments without retention elements and thus no connection to the implants. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A Locator with retention elements | Device | Insertion of GC Pilier locator abutments with retention elements |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life (OHIP-G-49) | 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) | 3 months after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| masticatory function | 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. | 3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3) |
| Plaque index |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Reiner Mengel, Professor MD | Dept. of Prosthodontics and Orofacial Function Philipps-University, School of Dental Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Prosthodontics and Orofacial Function Philipps-University, School of Dental Medicine | Marburg | 35033 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19467020 | Background | Assuncao WG, Barao VA, Delben JA, Gomes EA, Tabata LF. A comparison of patient satisfaction between treatment with conventional complete dentures and overdentures in the elderly: a literature review. Gerodontology. 2010 Jun;27(2):154-62. doi: 10.1111/j.1741-2358.2009.00299.x. Epub 2009 May 6. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009066 | Mouth, Edentulous |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D014076 | Tooth Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| B Locator without retention elements | Device | Insertion of GC Pilier locator abutments without retention elements |
|
The Plaque index (Silness and Loe 1964) will be assessed and the change from baseline will be documented. |
| 3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3) |
| Probing pocket depth | 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. | 3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3) |
| Gingival index | The Gingival index (Loe and Silness 1963) will be assessed and the change from baseline will be documented. | 3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3) |
| Gingival recessions | The Gingival recessions at teeth will be assessed and the change from baseline will be documented. | 3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3) |
| Mucosal recessions | The mucosal recessions at implants will be assessed and the change from baseline will be documented. | 3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3) |
| width of keratinized gingiva/mucosa | The width of keratinized gingiva/mucosa will be assessed and the change from baseline will be documented. | 3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3) |
| intraoral photo-documentation | A photo-documentation (intraoral) will be done to assess the changes from baseline. | 3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3) |