Influence of Implants and Locators for Improved Retention

Study Overview
=================
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.

Official Title
-----------------
Influence of Implants and Locators for Improved Retention of Mandibular Full Dentures on Patient's Quality of Life and Oral Function. A Controlled, Randomized and Prospective Study

Conditions
-----------------
Mouth, Edentulous

Intervention / Treatment
-----------------
* Device: A Locator with retention elements
* Device: B Locator without retention elements


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A Locator with retention elements<br>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. | Device: A Locator with retention elements<br>* Insertion of GC Pilier locator abutments with retention elements<br>|
| Active Comparator: B Locator without retention elements<br>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. | Device: B Locator without retention elements<br>* Insertion of GC Pilier locator abutments without retention elements<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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) |