NCT03126942

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2018

Typical duration 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

First Submitted

Initial submission to the registry

April 13, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 25, 2017

Completed
10 months until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 8, 2021

Completed
Last Updated

September 5, 2021

Status Verified

September 1, 2021

Enrollment Period

2.6 years

First QC Date

April 13, 2017

Last Update Submit

September 3, 2021

Conditions

Edentulous MouthEdentulous Jaw

Keywords

Aged patientsCost EstimatesComplete DentureDental EconomicsDental ImplantsDental Prosthesis, Implant-SupportedDenture RetentionMinimally Invasive Surgical ProceduresOral Health-Related Quality of LifeOverdenturePatient Acceptance of Health CareQuality of HealthcareQuality of LifePatient SatisfactionSingle implant overdenture

Outcome Measures

Primary Outcomes (1)

  • Denture satisfaction

    To be assessed by specific questionnaires

    18 months

Secondary Outcomes (9)

  • Oral health-related quality of life

    18 months

  • Overdenture rotation

    18 months

  • Success/survival rate

    18 months

  • Plaque Index

    18 months

  • Presence of calculus

    18 months

  • +4 more secondary outcomes

Other Outcomes (1)

  • Qualitative assessment

    6 months

Study Arms (2)

Novaloc, then Locator

EXPERIMENTAL

Participants 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

Device: NovalocDevice: Locator

Locator, then Novaloc

ACTIVE COMPARATOR

Participants 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

Device: NovalocDevice: Locator

Interventions

NovalocDEVICE

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

Locator, then NovalocNovaloc, then Locator
LocatorDEVICE

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

Locator, then NovalocNovaloc, then Locator

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McGill University, Faculty of Dentistry

Montreal, Quebec, H3A1G1, Canada

Location

Related Publications (2)

  • 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.

    PMID: 36127832DERIVED

  • 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.

    PMID: 29685161DERIVED

MeSH Terms

Conditions

Mouth, EdentulousJaw, EdentulousPatient Acceptance of Health CarePatient Satisfaction

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesTooth DiseasesJaw DiseasesMusculoskeletal DiseasesTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Raphael F de Souza

    McGill University, Faculty of Dentistry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2017

First Posted

April 25, 2017

Study Start

March 1, 2018

Primary Completion

September 30, 2020

Study Completion

March 8, 2021

Last Updated

September 5, 2021

Record last verified: 2021-09

Locations

CA(1)