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Validation and Cross-Cultural Adaptation of the Romanian Version of Oral Health Impact Profile in Edentulous Adults (ROM-OHIP-ED)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
ITI (INTERNATIONAL TEAM FOR IMPLANTOLOGY)
Information provided by:
Concordia Dent Srl
ClinicalTrials.gov Identifier:
NCT01392456
First received: July 11, 2011
Last updated: July 14, 2011
Last verified: June 2011
History of Changes
  Purpose

The aim of the study is:

  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. To compare satisfaction of 69 fully mandibular edentulous patients rehabilitated with implant-supported overdentures with three different types of retention: Retentive Anchors, Magnets, Locator.

Condition Intervention
Severe Atrophy of the Edentulous Mandible
 Procedure: Insertion of two screw type dental implants

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Patient Satisfaction With the Use of Three Different Systems as Retention for Implant Supported Mandibular Overdentures.

Resource links provided by NLM:

MedlinePlus related topics: Dental Health
U.S. FDA Resources

Further study details as provided by Concordia Dent Srl:

Primary Outcome Measures:
  • OHIP-EDENT linguistic and cultural adaptation in Romanian [ Time Frame: Two-weeks ] [ Designated as safety issue: No ]

    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.


Secondary Outcome Measures:
  • Evaluation of patient satisfaction with the use of three different systems as retention for implant supported mandibular overdentures. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

    Patient satisfaction is assessed with the use of OHIP-EDENT questionnaire validated in Romanian language.

    The questionnaire is administrated initial (before surgery for assessing patient satisfaction with the original denture), after 6 months of implant over-denture insertion (T) and at 1,3 and 5-year follow-up (T1, T3, T5).

    The means scores will be calculated. Lower scores represents a good perception of the oral conditions, good satisfaction level and good masticatory capacity.



Enrollment: 69
Study Start Date: June 2004
Estimated Study Completion Date: December 2012
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Retentive Anchor Group
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
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).
Other Name: Straumann (Institute Straumann AG, Basel, Switzerland)
Active Comparator: Magnet Group
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
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).
Other Name: Straumann (Institute Straumann AG, Basel, Switzerland)
Active Comparator: Locator Group
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
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).
Other Name: Straumann (Institute Straumann AG, Basel, Switzerland)

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  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01392456

Locations
Romania
Concordia Dent Clinic
Bucharest, Romania, 041335
Sponsors and Collaborators
Concordia Dent Srl
ITI (INTERNATIONAL TEAM FOR IMPLANTOLOGY)
Investigators
Principal Investigator: CORINA MARILENA I CRISTACHE, DMD, PhD CONCORDIA DENT CLINIC
  More Information

Publications:

Responsible Party: CORINA MARILENA CRISTACHE, DMD, PhD, CONCORDIA DENT CLINIC
ClinicalTrials.gov Identifier: NCT01392456     History of Changes
Other Study ID Numbers: 507-207, 316/03 & 507-207
Study First Received: July 11, 2011
Last Updated: July 14, 2011
Health Authority: Romania: Ministry of Public Health

Keywords provided by Concordia Dent Srl:
OHIP-EDENT, VALIDATION, OVERDENTURE, ROMANIAN

Additional relevant MeSH terms:
Mouth, Edentulous
Atrophy
Mouth Diseases
 Stomatognathic Diseases
Tooth Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 19, 2013