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Completed

NCT Number: NCT03126942

Single-implant Overdentures Retained by the Novaloc Attachment System

The objective of this explanatory mixed methods study is to compare a novel attachment system (Novaloc) to a traditional alternative (Locator) for single implants in the mandible of edentate elders. The investigators will carry out a randomized cross-over clinical trial comparing Novaloc attachments to Locators for single-implant mandibular overdentures in edentate elders. Participants will be followed for three months with each attachment type; patient-based, clinical and economic outcomes will be gathered. A sample of 26 participants is estimated to be required to detect clinically relevant differences in terms of the primary outcome (patient ratings of general satisfaction). Participants will choose which attachment they wish to keep, then be interviewed about their experiences and preferences with a single implant prosthesis and with the 2 attachments. Data from the quantitative and qualitative assessments will be integrated through a mixed-methods explanatory strategy. A last quantitative assessment will take place after 12 months with preferred attachment; this latter assessment will enable the observation of attachments' long-term wear and maintenance events.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McGill University, Faculty of Dentistry

Montreal, Quebec, H3A1G1, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Not have had a tooth extraction within the past six months
  • Request implant stabilization of a mandibular conventional complete denture
  • Have clinically acceptable maxillary and mandibular complete dentures
  • Have adequate bone in the anterior mandible for the placement of a single 3.3 mm wide implant in the midline
  • Be able to maintain adequate oral hygiene and clean dentures;
  • Present no systemic conditions for which minor oral surgery would be counter-indicated
  • Have an adequate understanding of written and spoken English or French;
  • Be capable of giving written informed consent

Exclusion criteria

  • Severe/serious illness that requires frequent hospitalization
  • Impaired cognitive function
  • Unable to return for evaluations/study recalls
  • Have a history of radiation therapy to the orofacial region
  • Have specific conditions that may jeopardize the treatment, such as alcoholism or smoking (>10 cigarettes/day)
  • Have acute or chronic symptoms of parafunctional or temporomandibular disorders
  • Previous dental implant treatment

Following radiographic exam, investigators will exclude volunteers with bony pathologic lesions, less than 11 mm of minimum vertical mandibular bone height in the midline or width for planned implants, evident endosseous vascular structures or mandibular ridges with remaining alveolar sockets

Treatment and study plan

Novaloc

Device

Attachment composed by a polyetheretherketone (PEEK) capsule and carbon-coated abutment. The yellow (medium) retentive component will be used

Locator

Device

Traditional cylindrical attachment (Locator system) with pink (medium) retentive components

Primary outcomes

  1. Denture satisfaction

    Time frame: 18 months

    To be assessed by specific questionnaires

Secondary outcomes

  1. Oral health-related quality of life

    Time frame: 18 months

    To be assessed by the OHIP-EDENT (Oral Health Impact Profile, shortened version for edentulous subjects) questionnaire

  2. Overdenture rotation

    Time frame: 18 months

    Two questions regarding perceived rotation, as done by Kimoto et al. (Clin Oral Implants Res 2009;20:838-43)

  3. Success/survival rate

    Time frame: 18 months

    Success/survival rate of prostheses and implants (yes/no)

  4. Plaque Index

    Time frame: 18 months

    Presence of plaque according to Silness & Loe (Acta Odont Scand 1963;21:533-51) (ordinal scale ranging from 0 to 3)

  5. Presence of calculus

    Time frame: 18 months

    Presence of calculus according to Ramfjord (J Periodontol 1967;38:602-10) (ordinal scale ranging from 0 to 3)

  6. Peri-implant probing depth

    Time frame: 18 months

    Depth of peri-implant pockets (in mm)

  7. Bleeding on probing

    Time frame: 18 months

    Bleeding on probing around implant (yes/no)

  8. Mucosal inflammation

    Time frame: 18 months

    Signs of swelling or inflammation of the peri-implant-mucosa (yes/no, plus categorical evaluation - type of pathological change)

  9. Treatment costs

    Time frame: 18 months

    Specific forms quantifying costs involved with cost of labor, materials, radiographs, medications, patient's time and transportation expenses

Other outcomes

  1. Qualitative assessment

    Time frame: 6 months

    Qualitative assessment (descriptive approach based on transcribed interviews) regarding: a) patients' reasons for choosing one attachment system; b) their perceptions of the advantages and disadvantages of each attachment; and c) their experience of living with a single implant retention for their mandibular overdenture

Sponsors and collaborators

Lead sponsor

McGill University

Other

Collaborators

  • ITI International Team for Implantology, Switzerland
  • Institut Straumann AG

Registry information

Official study title

Single-implant Overdentures Retained by the Novaloc Attachment System: Study Protocol for a Mixed Methods Randomized Cross-over Trial

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Apr 25, 2017
Registry last updated
Sep 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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