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Single-implant Overdentures Retained by the Novaloc Attachment System

Primary Purpose

Edentulous Mouth, Edentulous Jaw

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Novaloc

Locator

About this trial

This is an interventional treatment trial for Edentulous Mouth focused on measuring 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

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

McGill University, Faculty of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Novaloc, then Locator

Locator, then Novaloc

Arm Description

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

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

Outcomes

Primary Outcome Measures

Denture satisfaction

To be assessed by specific questionnaires

Secondary Outcome Measures

Oral health-related quality of life

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

Overdenture rotation

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

Success/survival rate

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

Plaque Index

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

Presence of calculus

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

Peri-implant probing depth

Depth of peri-implant pockets (in mm)

Bleeding on probing

Bleeding on probing around implant (yes/no)

Mucosal inflammation

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

Treatment costs

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

Full Information

NCT ID

NCT03126942

First Posted

April 13, 2017

Last Updated

September 3, 2021

Sponsor

McGill University

Collaborators

ITI International Team for Implantology, Switzerland, Institut Straumann AG

1. Study Identification

Unique Protocol Identification Number

NCT03126942

Brief Title

Single-implant Overdentures Retained by the Novaloc Attachment System

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Completed

Study Start Date

March 1, 2018 (Actual)

Primary Completion Date

September 30, 2020 (Actual)

Study Completion Date

March 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

McGill University

Collaborators

ITI International Team for Implantology, Switzerland, Institut Straumann AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Edentulous Mouth, Edentulous Jaw

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Novaloc, then Locator

Arm Type

Experimental

Arm Description

Arm Title

Locator, then Novaloc

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Novaloc

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Locator

Intervention Description

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

Primary Outcome Measure Information:

Title

Denture satisfaction

Description

To be assessed by specific questionnaires

Time Frame

18 months

Secondary Outcome Measure Information:

Title

Oral health-related quality of life

Description

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

Time Frame

18 months

Title

Overdenture rotation

Description

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

Time Frame

18 months

Title

Success/survival rate

Description

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

Time Frame

18 months

Title

Plaque Index

Description

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

Time Frame

18 months

Title

Presence of calculus

Description

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

Time Frame

18 months

Title

Peri-implant probing depth

Description

Depth of peri-implant pockets (in mm)

Time Frame

18 months

Title

Bleeding on probing

Description

Bleeding on probing around implant (yes/no)

Time Frame

18 months

Title

Mucosal inflammation

Description

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

Time Frame

18 months

Title

Treatment costs

Description

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

Time Frame

18 months

Other Pre-specified Outcome Measures:

Title

Qualitative assessment

Description

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

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Raphael F de Souza

Organizational Affiliation

McGill University, Faculty of Dentistry

Official's Role

Principal Investigator

Facility Information:

Facility Name

McGill University, Faculty of Dentistry

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3A1G1

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

36127832

Citation

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. 2022 Sep 20:23800844221124083. doi: 10.1177/23800844221124083. Online ahead of print.

Results Reference

derived

PubMed Identifier

29685161

Citation

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.

Results Reference

derived

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Single-implant Overdentures Retained by the Novaloc Attachment System

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