Clinical trial NCT03126942: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: McGill University
Sponsor class: OTHER
Collaborators: name: ITI International Team for Implantology, Switzerland
name: Institut Straumann AG
First posted: 2017-04-25
Enrollment: 10
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Denture satisfaction
timeFrame: 18 months
Secondary outcomes:
measure: Oral health-related quality of life
timeFrame: 18 months
measure: Overdenture rotation
timeFrame: 18 months
measure: Success/survival rate
timeFrame: 18 months
measure: Plaque Index
timeFrame: 18 months
measure: Presence of calculus
timeFrame: 18 months
measure: Peri-implant probing depth
timeFrame: 18 months
measure: Bleeding on probing
timeFrame: 18 months
measure: Mucosal inflammation
timeFrame: 18 months
measure: Treatment costs
timeFrame: 18 months
Other outcomes:
measure: Qualitative assessment
timeFrame: 6 months
Locations:
city: Montreal
country: Canada
facility: McGill University, Faculty of Dentistry
state: Quebec
Study officials:
affiliation: McGill University, Faculty of Dentistry
name: Raphael F de Souza
role: PRINCIPAL_INVESTIGATOR
References:
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. 2024 Jan;9(1):27-41. doi: 10.1177/23800844221124083. Epub 2022 Sep 20.
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.