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Active, Not Recruiting

NCT Number: NCT02117856

Complete Lower Dentures on 1 or 2 Implants

This study is a randomized clinical trial to compare patient satisfaction and prosthetic outcomes with lower dentures retained by one or two implants. The investigators long-term objective is to establish evidence of the cost-effectiveness of a single implant intervention for improving tolerance to complete dentures. The investigators MAIN AIM will be to investigate patient satisfaction between and within groups with mandibular dentures retained by one or two implants over five years, and SECONDARILY to investigate the survival of implants, and the frequency of events to maintain the dentures and prosthetic attachments as clinically serviceable. Furthermore, multivariate analysis can assess the prediction of patient satisfaction with implant dentures based on various possible factors including age, health, demography and socioeconomic status, number of implants, and maintenance needs. Patient satisfaction will be measured by means of Visual Analogue Scales (VAS) including a measure of overall satisfaction and various specific aspects of satisfaction such as appearance, stability and comfort of the dentures.

The CENTRAL HYPOTHESIS is that mandibular complete dentures retained by single implants are at least as satisfying to patients over a five years period as those retained by two implants for the same period.

The SECONDARY HYPOTHESES are that:

i) there is no difference over five years between groups in the survival of original implants, or in the number of events for maintenance of the dentures or implant attachments; and ii) using each treatment group as it's own control, there is no change in patient satisfaction with lower dentures retained by either one or two implants during the five year loading period.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Tooth-loss Anodontia Behavior Complete Denture Complete Lower Denture Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Edentulous Mouth Health Behavior Mouth Diseases Mouth, Edentulous Patient Satisfaction Stomatognathic Diseases Stomatognathic System Abnormalities Tooth Abnormalities Tooth Diseases Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Oral Health Sciences, University of British Columbia

Vancouver, British Columbia, V6T 1Z3, Canada

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • functional in English or accompanied by a responsible adult who can provide translation services
  • able to consent to, and participate in, the treatment provided
  • available for the duration of the study
  • edentulous and with at least six month's experience with conventional complete dentures
  • currently wearing conventional complete dentures that are esthetically satisfactory to the patient and technically acceptable in the judgment of the study prosthodontist(s)
  • medically/psychologically suitable for implant surgery in the judgment of the study dentists

Exclusion criteria

  • insufficient alveolar bone height for implant(s) (< 10 mm)
  • history of head and neck radiation
  • systemic or neurological disease, including: American Society of Anesthesiologists (ASA) Class 3 with recently diagnosed severe systemic disease, e.g. recent (within 6 months) myocardial infarction or stroke; risks associated with bacteraemia, e.g. immune compromise, steroids, in-dwelling catheters, stents, prosthetic heart valves, etc.; Type 1 diabetes, pituitary and adrenal insufficiency, and untreated hypothyroidism; chronic granulomatous disease, e.g. tuberculosis and sarcoidosis; bone disease, e.g. histiocytosis X, Paget's disease, fibrous dysplasia; history of congenital or acquired uncontrolled bleeding, e.g. coumadin
  • previous oral implant treatment
  • need for additional pre-prosthetic surgery
  • need for new complete dentures
  • medically/psychologically unsuitable for surgery in the opinion of the study dentists

Treatment and study plan

1 implant placed surgically in the mandibular midline

Procedure

Participants receive an implant in the mandibular midline using a surgical flap procedure with local anaesthesia.

Other names: Implant is Solid Screw, SLA surface, Straumann Canada

2 implants placed surgically in the mandibular canine sites

Procedure

Participants receive implants bilaterally in the site of the mandibular canines using a surgical flap procedure with local anaesthesia.

Other names: Implants are Solid Screw, SLA surface, Straumann Canada

Soft reline (Coe Comfort) of the existing complete lower denture

Procedure

Participants receive a soft reline of the existing complete lower denture approximately 10 days after placement of the implant(s).

Other names: Soft reline is Coe Comfort, GC Corporation

2.25mm ball patrix placed on 1 healed implant

Device

A 2.25mm ball patrix is screwed onto the 1 implant approximately six weeks after placement of the implant.

Other names: Patrix is Spherical Stud Retentive Anchor, Straumann Canada

2.25mm ball patrices placed on 2 healed implants

Device

2.25mm ball patrices are screwed onto the 2 implants approximately six weeks after placement of the implants.

Other names: Patrix is Spherical Stud Retentive Anchor, Straumann Canada

Reline (Ivoclar acrylic-resin) with 1 retentive matrix in the lower denture

Procedure

Participants have their complete lower denture relined with a laboratory-processed acrylic resin to incorporate 1 retentive matrix in the denture-base to retain on the implant.

Other names: Reline is Ivoclar acrylic-resin, Ivoclar Vivaent Inc, Canada, Matrix is Straumann Gold Matrix, Straumann Canada

Reline (Ivoclar acrylic-resin) with 2 retentive matrices in the lower denture

Procedure

Participants have their complete lower denture relined with a laboratory-processed acrylic resin to incorporate 2 retentive matrices in the denture-base to retain on the implants

Other names: Reline is Ivoclar acrylic-resin, Ivoclar Vivaent Inc, Canada, Matrix is Straumann Gold Matrix, Straumann Canada

Primary outcomes

  1. Self-assessed VAS satisfaction with the mandibular denture

    Time frame: Annually during 10 years after attaching the mandibular implant denture

    Self-assessed satisfaction is measured on a 10 cm uninterrupted visual analogue scale (VAS) representing a continuum of feelings, with "unsatisfied" at one end and "satisfied" at the other. Each participant makes a global assessment of their satisfaction by marking an X on the line at a point corresponding to their response to the question: "How would you evaluate your 'overall satisfaction' with your lower denture?". A research assistant translates the mark into a number from 0 to 100 by superimposing a template with numbered intervals from 0 to 100 mm.

Secondary outcomes

  1. Change in self-assessed VAS satisfaction with the mandibular denture

    Time frame: From baseline (before implants) to each annual followup for 10 years after attaching the mandibular implant denture

    Self-assessed satisfaction is measured on a 10 cm uninterrupted visual analogue scale (VAS) representing a continuum of feelings, with "unsatisfied" at one end and "satisfied" at the other. Each participant makes a global assessment of their satisfaction by marking an X on the line at a point corresponding to their response to the question: "How would you evaluate your 'overall satisfaction' with your lower denture?". A research assistant translates the mark into a number from 0 to 100 by superimposing a template with numbered intervals from 0 to 100 mm.

  2. Cumulative Implant Survival

    Time frame: During the 10 years after attaching the mandibular implant denture

    Cumulative implant survival was judged by the time to the presence of clinical mobility, pain or suppuration associated with the original mandibular implants.

  3. The frequency of prosthetic maintenance events for the mandibular implant overdenture

    Time frame: During 10 years after attaching the mandibular implant denture

    The frequency of prosthetic maintenance treatment events for the mandibular denture including adjustment, reattachment, or replacement of implant attachment components, and denture base fractures, relining or rebasing, and denture replacement with a new lower denture.

  4. Time to provide the initial surgical and prosthetic treatment for the mandibular implant overdenture intervention

    Time frame: From baseline (before implants) until attachment of the mandibular implant denture, 6 weeks after implant placement

    This is the total professional chair-time recorded to provide the initial surgical and prosthetic treatment for the mandibular implant overdenture intervention.

  5. Costs to provide the initial surgical and prosthetic treatment for the mandibular implant overdenture intervention

    Time frame: From baseline (before implants) until attachment of the mandibular implant denture, 6 weeks after implant placement

    This is the total cost of components and professional and dental laboratory fees to provide the initial surgical and prosthetic treatment for the mandibular implant overdenture intervention.

  6. Time to provide prosthetic maintenance treatment for the mandibular implant overdenture

    Time frame: During 1 year after attachment of the mandibular implant denture

    This is the total professional chair-time recorded to provide prosthetic maintenance treatment for the maxillary denture and the mandibular implant overdenture including contour adjustments, and adjustment, reattachment, or replacement of implant attachment components, and denture repairs, relining or rebasing.

  7. Costs to provide prosthetic maintenance treatment for the mandibular implant overdenture

    Time frame: During 1 year after attachment of the mandibular implant denture

    This is the total cost of components and professional and dental laboratory fees to provide prosthetic maintenance treatment for the maxillary denture and the mandibular implant overdenture including contour adjustments, and adjustment, reattachment, or replacement of implant attachment components, and denture repairs, relining or rebasing.

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)
  • ITI International Team for Implantology, Switzerland
  • Straumann Canada Ltd.

Registry information

Official study title

A Randomized Clinical Trial Comparing Patient Satisfaction and Prosthetic Outcomes With Mandibular Implant Overdentures Retained by 1 or 2 Implants

Important dates

Study start
2002
Primary completion
2027
Study completion
2027
First posted
Apr 21, 2014
Registry last updated
Jun 19, 2019

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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