Single-implant Overdentures Retained by the Novaloc Attachment System

Edentulous Jaw Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03126942
• Other study ID #: A03-M07-17A
• Secondary ID: 1185_2016
• Status: Completed
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: March 8, 2021

Study information

• Verified date: September 2021
• Source: McGill University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 8, 2021
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Edentulous Jaw
• Edentulous Mouth
• Jaw, Edentulous
• Mouth, Edentulous

Intervention

Device:
• Novaloc
Attachment composed by a polyetheretherketone (PEEK) capsule and carbon-coated abutment. The yellow (medium) retentive component will be used
• Locator
Traditional cylindrical attachment (Locator system) with pink (medium) retentive components

Locations

Country	Name	City	State
Canada	McGill University, Faculty of Dentistry	Montreal	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
McGill University	Institut Straumann AG, ITI International Team for Implantology, Switzerland

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Denture satisfaction	To be assessed by specific questionnaires	18 months
Secondary	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
Secondary	Overdenture rotation	Two questions regarding perceived rotation, as done by Kimoto et al. (Clin Oral Implants Res 2009;20:838-43)	18 months
Secondary	Success/survival rate	Success/survival rate of prostheses and implants (yes/no)	18 months
Secondary	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
Secondary	Presence of calculus	Presence of calculus according to Ramfjord (J Periodontol 1967;38:602-10) (ordinal scale ranging from 0 to 3)	18 months
Secondary	Peri-implant probing depth	Depth of peri-implant pockets (in mm)	18 months
Secondary	Bleeding on probing	Bleeding on probing around implant (yes/no)	18 months
Secondary	Mucosal inflammation	Signs of swelling or inflammation of the peri-implant-mucosa (yes/no, plus categorical evaluation - type of pathological change)	18 months
Secondary	Treatment costs	Specific forms quantifying costs involved with cost of labor, materials, radiographs, medications, patient's time and transportation expenses	18 months