NCT01392456

Brief Summary

The aim of the study is:

  1. 1.To validate the Romanian translation of OHIP-EDENT (Oral Health Impact Profile in Edentulous Adults), the short form of OHIP (Oral Health Impact Profile) developed by Allen and Locker for edentulous adults. The OHIP questionnaire is an efficient instrument for assessment of OHRQoL - Oral Health-Related Quality of Life.
  2. 2.To compare satisfaction of 69 fully mandibular edentulous patients rehabilitated with implant-supported overdentures with three different types of retention: Retentive Anchors, Magnets, Locator.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 1, 2004

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 12, 2011

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

February 4, 2015

Status Verified

February 1, 2015

Enrollment Period

6.3 years

First QC Date

July 11, 2011

Last Update Submit

February 2, 2015

Conditions

Severe Atrophy of the Edentulous Mandible

Keywords

OHIP-EDENT, VALIDATION, OVERDENTURE, ROMANIAN

Outcome Measures

Primary Outcomes (1)

  • OHIP-EDENT linguistic and cultural adaptation in Romanian

    Steps for validation: * linguistic and cultural adaptation of the original instrument to Romanian; * pilot study to assess face and content validity; * main study to assess the reliability and construct validity. OHIP-EDENT questionnaire includes 19-items addressing masticatory capacity, pleasure of eating, level of comfort, and relationship among others while wearing the prosthesis and detects the impact of oral health in the quality of life of edentulous adults wearing total prosthesis. Response categories:4=very often; 3=fairly often; 2=occasionally; 1=hardly ever; 0=never/don't know.

    Two-weeks

Secondary Outcomes (1)

  • Evaluation of patient satisfaction with the use of three different systems as retention for implant supported mandibular overdentures.

    5 years

Study Arms (3)

Retentive Anchor Group

ACTIVE COMPARATOR

23 fully edentulous patients will receive Retentive Anchors (Institute Straumann AG, Basel Switzerland)as retention system for the two implant overdenture.

Procedure: Insertion of two screw type dental implants

Magnet Group

ACTIVE COMPARATOR

23 fully edentulous patients will receive Magnets (Institute Straumann AG, Basel Switzerland)as retention system for the two implant overdenture.

Procedure: Insertion of two screw type dental implants

Locator Group

ACTIVE COMPARATOR

23 fully edentulous patients will receive Locator (Institute Straumann AG, Basel Switzerland)as retention system for the two implant overdenture.

Procedure: Insertion of two screw type dental implants

Interventions

Insertion of two screw type dental implantsPROCEDURE

Each patient (of the 69 recruited) will receive 2 screw-type Straumann (Institute Straumann AG, Basel, Switzerland) standard implants Ø4.1 mm, with SLA surface in the canine region of the mandible with an interconnecting line approaching parallelism with the terminal mandibular hinge axis, in a 1-stage non-submerged procedure according to a strict protocol (Weingart D and ten Bruggenkate 2000).

Also known as: Straumann (Institute Straumann AG, Basel, Switzerland)
Locator GroupMagnet GroupRetentive Anchor Group

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Fully mandibular edentulous patients
  • Complains about the stability of the existing mandibular denture satisfactory from a technical point of view.
  • Acceptance of a mandibular over-denture retained by two endosseous implants.
  • Patients agree to a 5-year follow-up period.

You may not qualify if:

  • Insufficient bone volume (height and with) for inserting at least a 10 mm implant (Ø 4,1).
  • Angle class II relationship.
  • Physical severe consideration that will affect the minimal invasive surgical procedure or constitute a hindrance for a 5-year follow-up.
  • History of radiotherapy in the head and neck region.
  • History of pre-prosthetic surgery (including bone graft procedures) or previous oral implants.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Concordia Dent Clinic

Bucharest, 041335, Romania

Location

Related Publications (7)

  • Zani SR, Rivaldo EG, Frasca LC, Caye LF. Oral health impact profile and prosthetic condition in edentulous patients rehabilitated with implant-supported overdentures and fixed prostheses. J Oral Sci. 2009 Dec;51(4):535-43. doi: 10.2334/josnusd.51.535.

    PMID: 20032605BACKGROUND

  • Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3186-91. doi: 10.1097/00007632-200012150-00014. No abstract available.

    PMID: 11124735BACKGROUND

  • Assad AS, Abd El-Dayem MA, Badawy MM. Comparison between mainly mucosa-supported and combined mucosa-implant-supported mandibular overdentures. Implant Dent. 2004 Dec;13(4):386-94. doi: 10.1097/01.id.0000144512.43654.08.

    PMID: 15592001BACKGROUND

  • Weingart D, ten Bruggenkate CM. Treatment of fully edentulous patients with ITI implants. Clin Oral Implants Res. 2000;11 Suppl 1:69-82. doi: 10.1034/j.1600-0501.2000.011s1069.x.

    PMID: 11168258BACKGROUND

  • Chan MF, Johnston C, Howell RA, Cawood JI. Prosthetic management of the atrophic mandible using endosseous implants and overdentures: a six year review. Br Dent J. 1995 Nov 11;179(9):329-37. doi: 10.1038/sj.bdj.4808917.

    PMID: 7495628BACKGROUND

  • Davis DM, Packer ME. Mandibular overdentures stabilized by Astra Tech implants with either ball attachments or magnets: 5-year results. Int J Prosthodont. 1999 May-Jun;12(3):222-9.

    PMID: 10635189BACKGROUND

  • Naert I, Alsaadi G, Quirynen M. Prosthetic aspects and patient satisfaction with two-implant-retained mandibular overdentures: a 10-year randomized clinical study. Int J Prosthodont. 2004 Jul-Aug;17(4):401-10.

    PMID: 15382775BACKGROUND

Study Officials

  • CORINA MARILENA I CRISTACHE, DMD, PhD

    CONCORDIA DENT CLINIC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Corina Marilena Cristache, DMD, PhD, senior lecturer

Study Record Dates

First Submitted

July 11, 2011

First Posted

July 12, 2011

Study Start

June 1, 2004

Primary Completion

September 1, 2010

Study Completion

February 1, 2015

Last Updated

February 4, 2015

Record last verified: 2015-02

Locations

RO(1)