Attachment Systems for Implant Overdenture

NCT03640910 | Completed

• 1 other identifier: In_Vitro_Eq_Loc_Smart
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this randomized controlled trial is to compare peri-implant tissue health, number of complications, and patient's preference between two unsplinted overdenture attachments.

Conditions

Dental Implants; Dental Prosthesis Failure

Keywords

Dental implants; Overdenture; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Implant and prosthetic success rate

  An implant will be considered a failure if it presented with any mobility, assessed by tapping or rocking the implant head with the metallic handles of two instruments, progressive marginal bone loss or infection, and any mechanical complications rendering the implant unusable, although still mechanically stable in the bone.

  Up to 5 years after implant placement

Secondary Outcomes (2)

• Marginal bone loss

  Up to 5 years after implant placement

• Oral Health Impact Profile

  Up to 5 years after implant placement

Study Arms (2)

OT Equators® (Rhein83)

EXPERIMENTAL

After gingival healing the newest low-profile OT Equators® (Rhein83) will be screwed on to the implants, using the OT Equator® square screwdriver (Rhein83), with a torque range of 22-25 N cm. The cuff heights ranged from 0.5 to 7.0 mm, depending on the height of the transition zone of each implant, easily measured using the color-coded millimeter Cuff Height Measurer Gauge (Rhein83) after healing abutment removal.

Device: OT Equators® (Rhein83)

Locator® (Zest)

ACTIVE COMPARATOR

The low-profile attachments Locator® (Zest) will be screwed on to the implants, using the Locator® screwdriver (Zest), with a torque range of 20-25 N cm. The cuff heights of 2.5 or 4.0 mm, depending on the height of the transition zone of each implant, measured using the deep probe of the implant line after healing abutment removal.

Device: Locator® (Zest)

Interventions

OT Equators® (Rhein83) DEVICE

Attachment systems to retain an implant overdenture

OT Equators® (Rhein83)

Locator® (Zest) DEVICE

Attachment systems to retain an implant overdenture

Locator® (Zest)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any healthy individual (ASA 1 and 2)( (Dexter and Thompson, 2001), aged 18 years or older at the time of enrollment, with complete edentulous mandible, or a failing dentition in the mandible, scheduled to receive an implant supported overdenture, will be considered eligible for the study.

You may not qualify if:

• General contraindications to oral surgery, pregnancy or nursing, intravenous bisphosphonate therapy, alcohol or drug abuse, heavy smoking (≥ 20 cigarettes/day), radiation therapy to the head or neck region within the last five years, parafunctional activity, untreated periodontitis, and allergy or adverse reactions to the restorative materials.

Sponsors & Collaborators

• Rhein 83 Srl: lead

Study Sites (1)

Studio Dr. Marco Tallarico

Rome, 00151, Italy

Location

Study Officials

• Marco Tallarico, Dr

  University of Aldent, Tirana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal advisor

Study Record Dates

• First Submitted: March 29, 2018
• First Posted: August 21, 2018
• Study Start: January 1, 2018
• Primary Completion: January 30, 2020
• Study Completion: December 31, 2020
• Last Updated: February 9, 2021

Record last verified: 2021-02

Locations

IT (1)