Titanium Zirconium (TiZr) Mini Implants

Dental Implants Clinical Trial

Official title:

Is the Stabilization of a Mandibular Overdenture Employing Four Novel One-piece Immediately Loaded TiZr Implants With Miniaturized Stud-type Attachments a Feasible Alternative to Two Two-piece Early Loaded Tissue-level Implants With Regular Stud-type Attachments?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03837158
• Other study ID #: Mini 1286_2018
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: December 2025

Study information

• Verified date: November 2023
• Source: University of Bern
• Contact: Martin Schimmel, Prof.
• Phone: 0316322597
• Email: martin.schimmel[@]zmk.unibe.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

H0: "Within the first year post-placement, four interforaminally placed, immediately loaded 2.4 mm narrow-diameter one-piece TiZr implants with miniaturized stud-type attachments show improved patient-reported outcome measures (PROMS) compared to two interforaminally placed, early loaded, TiZr two-piece implants with stud-type attachments to retain a mandibular overdenture."The specific aim is to compare both treatment alternatives to evaluate which one may be recommended for elderly edentulous patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: December 2025
• Est. primary completion date: February 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• At patient level:
• Written informed consent
• Age = 18 years
• Sufficient complete dentures (Marxkors and Ferger, 1989) not older than 1 year
• Patient is unsatisfied with mandibular denture to the degree that he/she seeks treatment
• At site level:
• Healed edentulous mandible (minimum 8 weeks since last extraction)
• Minimal ridge dimensions 5.5 mm (width) by 12 mm (height) in the anterior (interforaminal) area, allowing the placement of 3.3 (endosseous diameter) by 10 mm (length) implants
• Opposing dentition: complete denture on a edentulous maxilla
• Physical status (PS) 1 and 2 (American Society of Anesthesiologists)

Exclusion Criteria:

• At patient level
• Any physical or mental disorder that would interfere with the ability to perform adequate oral hygiene or the capability of providing written informed consent and compliance to the protocol
• Any disorder that would interfere with wound healing or represent a contraindication for oral surgery such as, but not limited to, uncontrolled diabetes or conditions resulting in or requiring immunosuppression, radiation, chemotherapy, frequent use of antibiotics or antiresorptive medication such as bisphosphonates
• Pregnancy or lactation
• Heavy smoking habit with > 20 cig/d
• Severe bruxism or clenching habits, present oro-facial pain
• At site level:
• Ridge defects requiring staged bone augmentation procedures (simultaneous Guided Bone Regeneration (GBR) within the ridge contour allowed)

Related Conditions & MeSH terms

• Dental Implants

Intervention

Procedure:
• early loading
two TiZr implants on SLA surface
• immediate loading
four TiZr implants on SLA surface

Locations

Country	Name	City	State
Switzerland	University of Bern	Bern
Switzerland	Private Practice Dr. B. Wallkamm	Langenthal	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University of Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Geriatric Oral Health Assessment Index (GOHAI)	Change from baseline questionnaires in Oral Health Related Quality of Life (OHRQoL).; Scores 0-60: higher values represent lower OHRQoL	One-year follow-up
Secondary	Additional Oral Health Impact Profile for edentulism (OHIP-EDENT)	Change from baseline questionnaires	Follow-up (up to 365 days)
Secondary	Additional PROM Denture Satisfaction Index (DSI)	Change in Denture Satisfaction higher values represent better satisfaction (0-1200mm)	Baseline, follow-up (up to 365 days)
Secondary	Implant Survival	Survival (yes/no)	at implant loading (at 24 hours for arm B, at 6-8 weeks for arm A), at the one-year follow-up
Secondary	Implant Success	Success according to Misch (2007) Misch criteria scores 1-4: higher values represent better success	at implant loading (at 24 hours for arm B, at 6-8 weeks for arm A), at the one-year follow-up
Secondary	Prosthetic Survival	Prosthetic Survival (yes/no): is the denture still in place?	Baseline, follow-up (up to 365 days)
Secondary	Chewing Efficiency	Color mixing test	Baseline, follow-up (up to 365 days)
Secondary	Plaque Index	Plaque Index Scores 0-3 3= thick plaque is visible along gingival margin 2= plaque is visible along gingival margin, with or without air drying; 1= following air drying, plaque is not visible but can be wiped off with an explorer 0= following air drying, plaque is not visible nor can be wiped off with an explorer	at implant loading (at 24 hours for arm B, at 6-8 weeks for arm A), at the one-year follow-up
Secondary	Bleeding Index	Bleeding Index Scores 0-3 0= Healthy gingival; Gingival look inflamed, but don't bleed when probed; Gingival look inflamed and bleed when probed; Ulceration and spontaneous bleeding	at implant loading (at 24 hours for arm B, at 6-8 weeks for arm A), at the one-year follow-up
Secondary	Pocket Probing depth	depth measured in mm	at implant loading (at 24 hours for arm B, at 6-8 weeks for arm A), at the one-year follow-up
Secondary	Time-Cost-Analysis	Total treatment time will be collected and added. Total treatment cost will be evaluated and a ratio will be calculated. The groups will be compared on the base of this ration	After surgery, after implants loading, after follow-up (up to 365 days)
Secondary	Cost Effectiveness and Willingness to Pay	Cost effectiveness wil be calculated as a ratio of treatment cost in relation to change of GOHAI sum score. This will allow to evaluate how much monetary item is needed to achieve a change in GOHAI	Total change and time at 1y follow-up
Secondary	In-vivo evaluated loss of retentive force	Measurement with a hand-held digital force gauge	after implant loading (expected to be after 6 weeks on average) and at follow-up (up to 365 days)