Outcome of Implant-supported Overdentures

NCT03777748 | Unknown

• 1 other identifier: UKA 373147
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this pilot study was to assess survival rates and peri-implant bone loss of two narrow-diameter titanium-zirconium implants supporting maxillary and mandibular overdentures during an observation time of 3 years. The masticatory performance, self-reported chewing ability and change of oral health impact profile (OHIP) after rehabilitation were also investigated.

Conditions

Alveolar Bone Loss; Bone Resorption; Dental Implants; Edentulous Maxilla; Edentulous Patient

Keywords

Oral Health Impact Factor; Survival rate; Maxillary overdenture; Implant-Supported; Bone Resorption; Titanium-Zirconium; Anchor System

Outcome Measures

Primary Outcomes (2)

• Investigation of the success rates of the implants

  Implant fracture, implant loss

  5 Years

• Marginal bone loss

  Measurement of marginal bone loss on standardized radiographs \[mm\]

  5 years

Secondary Outcomes (7)

• Probing depth

  5 Years

• Gingival status

  5 Years

• Oral hygiene

  5 Years

• Oral Health Quality of Life

  5 years

• Chewing satisfaction

  5 years

Study Arms (1)

Two dental implants in the edentulous maxilla and mandible

EXPERIMENTAL

Edentulous maxilla und mandible are treated with two diameter-reduced tissue level implants (Straumann, Basel) and anchored with CM LOC® and CM LOC Flex® attachments (Cendres+Métaux SA, Bienne).

Device: dental implants and stud attachments

Interventions

dental implants and stud attachments DEVICE

Also known as: CM LOC® and CM LOC Flex® (Cendres+Métaux SA, Bienne), (sandblasted/acid-etched) SLActive® Roxolid® implants, Ø 3.3 mm (Straumann, Switzerland)

Two dental implants in the edentulous maxilla and mandible

Eligibility Criteria

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

You may qualify if:

• Female and male subjects older than 18 years.
• Edentulous patients with a bone atrophy, which necessitates the use of diameter-reduced implants and excessive augmentation procedures are denied by the patient.
• Sufficient bone supply with minimal risk of injury to neighboring structures when using two 10 mm or longer implants per jaw.
• Bone height above the N. alveolaris inferior of at least 11 mm and the precondition of a one-stage implantation and augmentation.
• Good health condition according to the Physical Status Classification System one or two (American Society of Anesthesiologists, ASA 2010)
• Good oral hygiene and an at most moderate tobacco consumption
• Signed informed consent

You may not qualify if:

• Indication for large augmentations of the jaw bone
• Allergy to metallic implant components or prosthesis plastics
• Bisphosphonate therapy
• Chemo-, immuno-, or radiation therapy
• Psychological disorder
• Substance abuse
• Pregnant woman
• Persons who are placed in an institution on a judicial or administrative order
• Any other circumstances that prevent the use of oral surgery

Sponsors & Collaborators

• RWTH Aachen University: lead
• Institut Straumann AG: collaborator

Related Publications (11)

• Murphy WM. The effect of complete dentures upon taste perception. Br Dent J. 1971 Mar 2;130(5):201-5. doi: 10.1038/sj.bdj.4802647. No abstract available.

  PMID: 5278921 BACKGROUND

• Zembic A, Wismeijer D. Patient-reported outcomes of maxillary implant-supported overdentures compared with conventional dentures. Clin Oral Implants Res. 2014 Apr;25(4):441-50. doi: 10.1111/clr.12169. Epub 2013 Apr 15.

  PMID: 23581398 BACKGROUND

• Roccuzzo M, Bonino F, Gaudioso L, Zwahlen M, Meijer HJ. What is the optimal number of implants for removable reconstructions? A systematic review on implant-supported overdentures. Clin Oral Implants Res. 2012 Oct;23 Suppl 6:229-37. doi: 10.1111/j.1600-0501.2012.02544.x.

  PMID: 23062145 BACKGROUND

• Kern JS, Kern T, Wolfart S, Heussen N. A systematic review and meta-analysis of removable and fixed implant-supported prostheses in edentulous jaws: post-loading implant loss. Clin Oral Implants Res. 2016 Feb;27(2):174-95. doi: 10.1111/clr.12531. Epub 2015 Feb 9.

  PMID: 25664612 BACKGROUND

• Richter E, Knapp WJI. Auf zwei Eckzahnimplantaten abgestützte Oberkiefer-Coverdentureprothesen-Ergebnisse einer klinischen Studie. 2010;18:165-174.

  BACKGROUND

• Zembic A, Tahmaseb A, Jung RE, Wismeijer D. One-year results of maxillary overdentures supported by 2 titanium-zirconium implants - implant survival rates and radiographic outcomes. Clin Oral Implants Res. 2017 Jul;28(7):e60-e67. doi: 10.1111/clr.12863. Epub 2016 May 6.

  PMID: 27150942 BACKGROUND

• Al-Nawas B, Bragger U, Meijer HJ, Naert I, Persson R, Perucchi A, Quirynen M, Raghoebar GM, Reichert TE, Romeo E, Santing HJ, Schimmel M, Storelli S, ten Bruggenkate C, Vandekerckhove B, Wagner W, Wismeijer D, Muller F. A double-blind randomized controlled trial (RCT) of Titanium-13Zirconium versus Titanium Grade IV small-diameter bone level implants in edentulous mandibles--results from a 1-year observation period. Clin Implant Dent Relat Res. 2012 Dec;14(6):896-904. doi: 10.1111/j.1708-8208.2010.00324.x. Epub 2011 Mar 17.

  PMID: 21414131 BACKGROUND

• Chiapasco M, Casentini P, Zaniboni M, Corsi E, Anello T. Titanium-zirconium alloy narrow-diameter implants (Straumann Roxolid((R))) for the rehabilitation of horizontally deficient edentulous ridges: prospective study on 18 consecutive patients. Clin Oral Implants Res. 2012 Oct;23(10):1136-41. doi: 10.1111/j.1600-0501.2011.02296.x. Epub 2011 Aug 18.

  PMID: 22092806 BACKGROUND

• Passia N, Ghazal M, Kern M. Long-term retention behaviour of resin matrix attachment systems for overdentures. J Mech Behav Biomed Mater. 2016 Apr;57:88-94. doi: 10.1016/j.jmbbm.2015.11.038. Epub 2015 Dec 7.

  PMID: 26705935 BACKGROUND

• Di Francesco F, De Marco G, Gironi Carnevale UA, Lanza M, Lanza A. The number of implants required to support a maxillary overdenture: a systematic review and meta-analysis. J Prosthodont Res. 2019 Jan;63(1):15-24. doi: 10.1016/j.jpor.2018.08.006. Epub 2018 Sep 28.

  PMID: 30269880 BACKGROUND

• Jordan RA, Bodechtel C, Hertrampf K, Hoffmann T, Kocher T, Nitschke I, Schiffner U, Stark H, Zimmer S, Micheelis W; DMS V Surveillance Investigators' Group. The Fifth German Oral Health Study (Funfte Deutsche Mundgesundheitsstudie, DMS V) - rationale, design, and methods. BMC Oral Health. 2014 Dec 29;14:161. doi: 10.1186/1472-6831-14-161.

  PMID: 25547464 BACKGROUND

MeSH Terms

Conditions

Alveolar Bone Loss; Bone Resorption

Interventions

Dental Implants

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Materials; Biomedical and Dental Materials; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2018
• First Posted: December 17, 2018
• Study Start: June 1, 2013
• Primary Completion: April 1, 2016
• Study Completion: December 30, 2022
• Last Updated: March 12, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share