Effectiveness of Removable Prosthesis Retained by 4 Implant-supported Locator-Attachments

NCT02380404 | Completed

• 1 other identifier: 958_2013
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

1\. Hypothesis/Specific aims The aim of the present study proposal is to validate an implant treatment concept in the edentulous upper maxilla using four implants-supported locators abutments to retain removable prosthesis. Specific aims:

• The primary objective of the study is to evaluate the implant and prosthodontics success rates of the proposed implant treatment approach after a follow-up period of 1, 3 and 5 years as well as the biological and prosthodontics complications.
• The secondary objective is to assess the evolution of patient centered outcomes with the suggested treatment in the maxilla. Oral health-related quality of life (OHRQoL) and patients' satisfaction relating to their prostheses will be considered.
• The third objective will be to compare the implant, prosthodontics and patient-centered outcomes according to the implant distribution; 4 anterior to maxillary sinus (ANT) versus 2 anterior implants and 2 implants in the maxillary tuberosity (POST). Hypothesis:
• Implant survival rate using this treatment concept is similar to restoration with implant-supported fixed prosthesis, based on published data. No difference of implant survival rates is found between ANT and POST implant distribution.
• Prosthodontics survival rate using the following treatment concept is similar to the ones found with a bar, based on published data. The ANT implant distribution causes fewer prosthodontics complications compared to the POST implant distribution.
• There is a significant improvement in OHRQoL and patient satisfaction compared to the baseline OHRQoL observed with a conventional removable denture. The levels of improvement OHRQoL and patient satisfaction are similar for ANT and POST implant distributions.

Conditions

Edentulous Alveolar Ridge

Keywords

Edentulous maxilla

Outcome Measures

Primary Outcomes (1)

• Implant outcomes

  At each follow-up visit (3 months, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years), a clinical exam including plaque assessment, bleeding on probing and mucosal palpation will be done. A CBCT scan will be done directly after surgery and at one year post-surgery. Specifically, the integration will be considered successful if the following parameters are met: (1) absence of recurring peri-implant infection with suppuration; (2) absence of persistent subjective complaints such as pain, foreign body sensation, and/or dysesthesia; (3) absence of a continuous radiolucency around the implant; and (4) absence of any detectable implant mobility. Marginal bone levels will be measured using CBCT radiograph at baseline and 1, 3 and 5 years follow-up, using the implant neck as reference point and calibrating them using Image J64. Marginal bone remodeling will be calculated accordingly. CBCT radiographs will be taken using the bisector technique.

  5 years

Secondary Outcomes (1)

• Prosthodontics success rates

  5 years

Other Outcomes (1)

• Quality of life and self-assessment

  12 months

Study Arms (1)

Edentulous maxilla

Ibuprofen (600 mg - Film-coated Tablets) 3x/day before the surgery. Duration : 5 days Amoxicilline Teva (500 mg - dispersible tablets) 3x/day before the surgery. Duration : 16 days

Procedure: Implants-supported locators placement

Interventions

Implants-supported locators placement PROCEDURE

Antibiotics will be prescribed 1 day before surgery and continued for 5 days. Three calibrated surgeons will place 4 NN or RN Roxolid tissue level implants. Two implants have to be placed in the ANT region (lateral or canine) and 2 implants in the POST region (as distal as possible). Angulated implant and placement of implant in the tuberosity region can be considered.

Also known as: Locators abutments, NN or RN Roxolid tissue level implants

Edentulous maxilla

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients from the Department of Periodontology and Oral Surgery, CHU of Liège

You may qualify if:

• Physical status according to ASA = 1, 2
• Wearing a complete upper denture that is adequate and in good conditions
• Signed informed consent form describing the purpose and process of the study

You may not qualify if:

• Uncontrolled periodontitis/peri-implantitis (lower jaw)
• Lack of bone for the placement of 4 implants of 3.3 diameter and 8 mm with bone regeneration.
• Tobacco use \> 10cigarettes/day

Sponsors & Collaborators

• University of Liege: lead
• Université de Liège: collaborator
• ITI International Team for Implantology, Switzerland: collaborator
• Institut Straumann AG: collaborator

Study Sites (2)

Hospital University of Liège (CHU-Ulg)

Liège, 4000, Belgium

Location

University Hospital of Liege

Liège, 4000, Belgium

Location

Related Publications (18)

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  PMID: 22111809 BACKGROUND

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  PMID: 9714961 BACKGROUND

• Slot W, Raghoebar GM, Vissink A, Huddleston Slater JJ, Meijer HJ. A systematic review of implant-supported maxillary overdentures after a mean observation period of at least 1 year. J Clin Periodontol. 2010 Jan;37(1):98-110. doi: 10.1111/j.1600-051X.2009.01493.x. Epub 2009 Dec 7.

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  PMID: 23581398 BACKGROUND

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  PMID: 22577941 BACKGROUND

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  PMID: 8193981 BACKGROUND

Study Officials

• France Lambert

  CHU of Liège

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Clinic

Study Record Dates

• First Submitted: March 6, 2014
• First Posted: March 5, 2015
• Study Start: April 2, 2014
• Primary Completion: March 1, 2016
• Study Completion: November 1, 2020
• Last Updated: May 19, 2022

Record last verified: 2022-05

Locations

BE (2)