NCT02551146

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 3, 2015

Completed
4 days until next milestone

Study Start

First participant enrolled

September 7, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 16, 2015

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2018

Completed
Last Updated

December 22, 2022

Status Verified

December 1, 2022

Enrollment Period

2.7 years

First QC Date

September 3, 2015

Last Update Submit

December 20, 2022

Conditions

Mouth, Edentulous

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • 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 index

    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)

  • +3 more secondary outcomes

Study Arms (2)

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.

Device: A Locator 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.

Device: B Locator without retention elements

Interventions

A Locator with retention elementsDEVICE

Insertion of GC Pilier locator abutments with retention elements

A Locator with retention elements
B Locator without retention elementsDEVICE

Insertion of GC Pilier locator abutments without retention elements

B Locator without retention elements

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Prosthodontics and Orofacial Function Philipps-University, School of Dental Medicine

Marburg, 35033, Germany

Location

Related 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.

    PMID: 19467020BACKGROUND

MeSH Terms

Conditions

Mouth, Edentulous

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesTooth Diseases

Study Officials

  • Reiner Mengel, Professor MD

    Dept. of Prosthodontics and Orofacial Function Philipps-University, School of Dental Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2015

First Posted

September 16, 2015

Study Start

September 7, 2015

Primary Completion

May 17, 2018

Study Completion

May 17, 2018

Last Updated

December 22, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)