Clinical trial NCT02551146: Influence of Implants and Locators for Improved Retention
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Mouth, Edentulous
Lead sponsor: Philipps University Marburg
Sponsor class: OTHER
First posted: 2015-09-16
Enrollment: 14
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Quality of life (OHIP-G-49)
timeFrame: 3 months after randomization
Secondary outcomes:
measure: masticatory function
timeFrame: 3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3)
measure: Plaque index
timeFrame: 3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3)
measure: Probing pocket depth
timeFrame: 3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3)
measure: Gingival index
timeFrame: 3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3)
measure: Gingival recessions
timeFrame: 3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3)
measure: Mucosal recessions
timeFrame: 3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3)
measure: width of keratinized gingiva/mucosa
timeFrame: 3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3)
measure: intraoral photo-documentation
timeFrame: 3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3)
Other outcomes:
Locations:
city: Marburg
country: Germany
facility: Dept. of Prosthodontics and Orofacial Function Philipps-University, School of Dental Medicine
Study officials:
affiliation: Dept. of Prosthodontics and Orofacial Function Philipps-University, School of Dental Medicine
name: Reiner Mengel, Professor MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.