Influence of Implants and Locators for Improved Retention

Mouth, Edentulous Clinical Trial

— GC  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02551146
• Other study ID #: KKS-217
• Status: Terminated
• Phase: N/A
• Start date: September 7, 2015
• Est. completion date: May 17, 2018

Study information

• Verified date: December 2022
• Source: Philipps University Marburg Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: May 17, 2018
• Est. primary completion date: May 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Mouth, Edentulous

Intervention

Device:
• A Locator with retention elements
Insertion of GC Pilier locator abutments with retention elements
• B Locator without retention elements
Insertion of GC Pilier locator abutments without retention elements

Locations

Country	Name	City	State
Germany	Dept. of Prosthodontics and Orofacial Function Philipps-University, School of Dental Medicine	Marburg

Sponsors (1)

Lead Sponsor	Collaborator
Philipps University Marburg Medical Center

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)