Single-implant Overdentures Retained by the Novaloc Attachment System

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.

Study Overview

• Status: Completed
• Conditions: Edentulous Jaw; Edentulous Mouth
• Intervention / Treatment: Device: Novaloc; Device: Locator

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3A1G1
      • McGill University, Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 63 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Novaloc, then Locator; 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: Novaloc; Attachment composed by a polyetheretherketone (PEEK) capsule and carbon-coated abutment. The yellow (medium) retentive component will be used; Device: Locator; Traditional cylindrical attachment (Locator system) with pink (medium) retentive components
Active Comparator: Locator, then Novaloc; 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: Novaloc; Attachment composed by a polyetheretherketone (PEEK) capsule and carbon-coated abutment. The yellow (medium) retentive component will be used; Device: Locator; Traditional cylindrical attachment (Locator system) with pink (medium) retentive components

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Denture satisfaction	To be assessed by specific questionnaires	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oral health-related quality of life	To be assessed by the OHIP-EDENT (Oral Health Impact Profile, shortened version for edentulous subjects) questionnaire	18 months
Overdenture rotation	Two questions regarding perceived rotation, as done by Kimoto et al. (Clin Oral Implants Res 2009;20:838-43)	18 months
Success/survival rate	Success/survival rate of prostheses and implants (yes/no)	18 months
Plaque Index	Presence of plaque according to Silness & Loe (Acta Odont Scand 1963;21:533-51) (ordinal scale ranging from 0 to 3)	18 months
Presence of calculus	Presence of calculus according to Ramfjord (J Periodontol 1967;38:602-10) (ordinal scale ranging from 0 to 3)	18 months
Peri-implant probing depth	Depth of peri-implant pockets (in mm)	18 months
Bleeding on probing	Bleeding on probing around implant (yes/no)	18 months
Mucosal inflammation	Signs of swelling or inflammation of the peri-implant-mucosa (yes/no, plus categorical evaluation - type of pathological change)	18 months
Treatment costs	Specific forms quantifying costs involved with cost of labor, materials, radiographs, medications, patient's time and transportation expenses	18 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative assessment	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	6 months

Collaborators and Investigators

• Sponsor: McGill University
• Collaborators: Institut Straumann AG; ITI International Team for Implantology, Switzerland
• Investigators: Principal Investigator: Raphael F de Souza, McGill University, Faculty of Dentistry

Publications and helpful links

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

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): September 30, 2020
• Study Completion (Actual): March 8, 2021

Study Registration Dates

• First Submitted: April 13, 2017
• First Submitted That Met QC Criteria: April 24, 2017
• First Posted (Actual): April 25, 2017

Study Record Updates

• Last Update Posted (Actual): September 5, 2021
• Last Update Submitted That Met QC Criteria: September 3, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Quality of Life; Dental Implants; Patient Satisfaction; Minimally Invasive Surgical Procedures; Patient Acceptance of Health Care; Overdenture; Complete Denture; Dental Economics; Denture Retention; Oral Health-Related Quality of Life; Aged patients; Cost Estimates; Dental Prosthesis, Implant-Supported; Quality of Healthcare; Single implant overdenture
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Jaw Diseases; Mouth, Edentulous; Jaw, Edentulous
• Other Study ID Numbers: A03-M07-17A; 1185_2016 (Other Grant/Funding Number: ITI - International Team for Implantology)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No