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Edentulous MouthNCT03126942

Single-implant Overdentures Retained by the Novaloc Attachment System

A study testing Novaloc and Locator in people with Edentulous Mouth and Edentulous Jaw, run by McGill University at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Edentulous Mouth, Edentulous Jaw
What is being tested?
Novaloc and Locator
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteCanada
Study dates
1 Mar 2018to 8 Mar 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • McGill University, Faculty of Dentistry

    Montreal, Quebec, H3A1G1

Other trials in Canada

About this study

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

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.

Being tested
Novaloc, Locator
Keywords
Aged patients, Cost Estimates, Complete Denture, Dental Economics, Dental Implants, Dental Prosthesis, Implant-Supported, Denture Retention, Minimally Invasive Surgical Procedures, Oral Health-Related Quality of Life, Overdenture, Patient Acceptance of Health Care, Quality of Healthcare, Quality of Life, Patient Satisfaction, Single implant overdenture
Medical subject headings
Mouth, Edentulous, Jaw, Edentulous, Patient Acceptance of Health Care, Patient Satisfaction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NovalocDevice

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

  • LocatorDevice

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

Study groups in NCT03126942
Study groupRoleWhat they receive
Novaloc, then LocatorExperimentalParticipants will receive the Novaloc attachment on a single implant inserted in the mandibular midline. This attachment will be used for 3 months and then changed by the Locator attachment. The second attachment will be used for another 3-month period. Participants will keep preferred attachment for further 12 months
Receives: Device: Novaloc; Device: Locator
Locator, then NovalocActive comparatorParticipants will receive the Locator attachment on a single implant inserted in the mandibular midline. This attachment will be used for 3 months and then changed by the Novaloc attachment. The second attachment will be used for another 3-month period. Participants will keep preferred attachment for further 12 months
Receives: Device: Novaloc; Device: Locator

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Denture satisfaction

    To be assessed by specific questionnaires

    Measured: 18 months

Secondary outcomes (9)

  1. Oral health-related quality of life

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

    Measured: 18 months

  2. Overdenture rotation

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

    Measured: 18 months

  3. Success/survival rate

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

    Measured: 18 months

  4. Plaque Index

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

    Measured: 18 months

  5. Presence of calculus

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

    Measured: 18 months

  6. Peri-implant probing depth

    Depth of peri-implant pockets (in mm)

    Measured: 18 months

  7. Bleeding on probing

    Bleeding on probing around implant (yes/no)

    Measured: 18 months

  8. Mucosal inflammation

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

    Measured: 18 months

  9. Treatment costs

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

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2017
  2. Study start1 Mar 2018
  3. Primary completion30 Sep 2020
  4. Study completion8 Mar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03126942
Sponsor's protocol ID
A03-M07-17A
Other IDs
1185_2016
Status last verified
Sep 2021
First submitted
13 Apr 2017
Last updated
5 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • de Souza RF, Jabbar AA, Jafarpour D, Bedos C, Esfandiari S, Makhoul NM, Dagdeviren D, Abi Nader S, Feine JS. Single-Implant Overdentures Retained by a Novel Attachment: A Mixed Methods Crossover Randomized Clinical Trial. JDR Clin Trans Res. 2024 Jan;9(1):27-41. doi: 10.1177/23800844221124083. Epub 2022 Sep 20.

    PubMed 36127832

  • de Souza RF, Bedos C, Esfandiari S, Makhoul NM, Dagdeviren D, Abi Nader S, Jabbar AA, Feine JS. Single-implant overdentures retained by the Novaloc attachment system: study protocol for a mixed-methods randomized cross-over trial. Trials. 2018 Apr 23;19(1):243. doi: 10.1186/s13063-018-2606-7.

    PubMed 29685161

Questions about this trial

What is this clinical trial studying?

A study testing Novaloc and Locator in people with Edentulous Mouth and Edentulous Jaw, run by McGill University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Denture satisfaction (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03126942, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.

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