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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Quality of life (OHIP-G-49)
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 45 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
A Locator with retention elements
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.
Intervention: A Locator with retention elements (Device)
B Locator without retention elements
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.
Intervention: B Locator without retention elements (Device)
Outcomes
Primary Outcomes
Quality of life (OHIP-G-49)
Time Frame: 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 Outcomes
- Mucosal recessions(3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3))
- width of keratinized gingiva/mucosa(3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3))
- Gingival index(3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3))
- intraoral photo-documentation(3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3))
- masticatory function(3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3))
- Plaque index(3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3))
- Probing pocket depth(3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3))
- Gingival recessions(3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3))