Clinical Study on the Efficiency of Three Different Attachment Systems for Implant-supported Mandibular Overdenture

NCT01034930 | Completed DMC

• 1 other identifier: 316/03-207-507
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the investigators study is to compare, in a prospective controlled clinical trial, the Locator® System with two other types of stress-breaking retention (Retentive Anchors and Magnets) for implant supported overdenture in atrophic edentulous mandible, with the use of Straumann Dental Implant System.

Conditions

MANDIBLE; ATROPHYC EDENTULOUS JAW

Keywords

MANDIBLE; IMPLANTS; OVERDENTURE

Outcome Measures

Primary Outcomes (1)

• The following parameters will be assessed for implant survival: - Gingiva-score, Plaque-score, Calculus, Bleeding-score, Probing pocket depth and Implant stability will be measured using Osstell (RFA).

  5 years

Secondary Outcomes (2)

• Radiographic outcome: Standardised intra-oral radiographs will be made using the long cone technique. Prosthetic maintenance and complications and soft-tissue complications of the denture bearing area will be recorded.

  5 years

• Patient satisfaction will be assessed with the aid of questionnaires: initial (with the original denture), after 6 months, 1-year and 5 years. Final costs for each type of retention will be calculated according to all the procedures and complications.

  5 years

Study Arms (3)

Retentive Anchors

ACTIVE COMPARATOR

23 patients will receive as retention system for overdentures Retentive Anchors (Straumann).

Procedure: Insertion of dental implants

Magnets

ACTIVE COMPARATOR

23 patients will receive Magnets (Straumann) as retention system for overdenture.

Procedure: Insertion of dental implants

Locator System

ACTIVE COMPARATOR

23 patients will receive Locator System (Straumann) as retention for the mandibular overdenture.

Procedure: Insertion of dental implants

Interventions

Insertion of dental implants PROCEDURE

Each patient will receive 2 screw-type Straumann (Institut Straumann AG, Basel, Switzerland) standard implants Ø4.1 mm, with SLA surface in the canine region of the mandible with an interconnecting line approaching parallelism with the terminal mandibular hinge axis, according to a standard surgical protocol.

Also known as: Mandibular overdenture metal reinforced will be made.

Locator System; Magnets; Retentive Anchors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Complains about the stability of the existing mandibular denture satisfactory from a technical point of view.
• Acceptance of a mandibular over-denture retained by two endosseous implants.
• Patients agree to a 5-year follow-up period.

You may not qualify if:

• Insufficient bone volume (height and with) for inserting at least a 10 mm implant (Ø 4,1).
• Angle class II relationship.
• Physical severe consideration that will affect the minimal invasive surgical procedure or constitute a hindrance for a 5-year follow-up.
• History of radiotherapy in the head and neck region.
• History of pre-prosthetic surgery (including bone graft procedures) or previous oral implants.

Sponsors & Collaborators

• Concordia Dent Srl: lead
• ITI International Team for Implantology, Switzerland: collaborator

Study Sites (1)

Concordia Dent Clinic

Bucharest, 041335, Romania

Location

Related Publications (11)

• Thomason JM, Feine J, Exley C, Moynihan P, Muller F, Naert I, Ellis JS, Barclay C, Butterworth C, Scott B, Lynch C, Stewardson D, Smith P, Welfare R, Hyde P, McAndrew R, Fenlon M, Barclay S, Barker D. Mandibular two implant-supported overdentures as the first choice standard of care for edentulous patients--the York Consensus Statement. Br Dent J. 2009 Aug 22;207(4):185-6. doi: 10.1038/sj.bdj.2009.728.

  PMID: 19696851 BACKGROUND

• Meijer HJ, Raghoebar GM, Batenburg RH, Vissink A. Mandibular overdentures supported by two Branemark, IMZ or ITI implants: a ten-year prospective randomized study. J Clin Periodontol. 2009 Sep;36(9):799-806. doi: 10.1111/j.1600-051X.2009.01442.x. Epub 2009 Jun 26.

  PMID: 19563327 BACKGROUND

• Meijer HJ, Raghoebar GM, Batenburg RH, Visser A, Vissink A. Mandibular overdentures supported by two or four endosseous implants: a 10-year clinical trial. Clin Oral Implants Res. 2009 Jul;20(7):722-8. doi: 10.1111/j.1600-0501.2009.01710.x. Epub 2009 Mar 27.

  PMID: 19489933 BACKGROUND

• Naert I, Alsaadi G, van Steenberghe D, Quirynen M. A 10-year randomized clinical trial on the influence of splinted and unsplinted oral implants retaining mandibular overdentures: peri-implant outcome. Int J Oral Maxillofac Implants. 2004 Sep-Oct;19(5):695-702.

  PMID: 15508985 BACKGROUND

• Naert I, Alsaadi G, Quirynen M. Prosthetic aspects and patient satisfaction with two-implant-retained mandibular overdentures: a 10-year randomized clinical study. Int J Prosthodont. 2004 Jul-Aug;17(4):401-10.

  PMID: 15382775 BACKGROUND

• Feine JS, Carlsson GE, Awad MA, Chehade A, Duncan WJ, Gizani S, Head T, Lund JP, MacEntee M, Mericske-Stern R, Mojon P, Morais J, Naert I, Payne AG, Penrod J, Stoker GT, Tawse-Smith A, Taylor TD, Thomason JM, Thomson WM, Wismeijer D. The McGill consensus statement on overdentures. Mandibular two-implant overdentures as first choice standard of care for edentulous patients. Montreal, Quebec, May 24-25, 2002. Int J Oral Maxillofac Implants. 2002 Jul-Aug;17(4):601-2. No abstract available.

  PMID: 12182304 BACKGROUND

• Boerrigter EM, van Oort RP, Raghoebar GM, Stegenga B, Schoen PJ, Boering G. A controlled clinical trial of implant-retained mandibular overdentures: clinical aspects. J Oral Rehabil. 1997 Mar;24(3):182-90.

  PMID: 9131473 BACKGROUND

• van Steenberghe D, Quirynen M, Naert I, Maffei G, Jacobs R. Marginal bone loss around implants retaining hinging mandibular overdentures, at 4-, 8- and 12-years follow-up. J Clin Periodontol. 2001 Jul;28(7):628-33. doi: 10.1034/j.1600-051x.2001.028007628.x.

  PMID: 11422583 BACKGROUND

• Cristache CM, Muntianu LA, Burlibasa M, Didilescu AC. Five-year clinical trial using three attachment systems for implant overdentures. Clin Oral Implants Res. 2014 Feb;25(2):e171-8. doi: 10.1111/clr.12086. Epub 2012 Dec 21.

  PMID: 23278517 BACKGROUND

• Cristache CM, Ionescu C, Cristache G, Ionescu I, Iliescu AA, Burlibasa M. A 5-year prospective randomised clinical trial on the efficiency of two different attachment systems as retention for implant-supported mandibular overdenture. Radiographic assessment, cost analysis and final evaluation of treatment's success. Metalurgia International vol. XIV (2009)Special Issue nr. 16:27-34.

  RESULT

• Cristache CM, Ionescu C, Burlibasa M, Cristache G, Iliescu AA, Dumitriu HT. Retentive anchors versus magnets as attachment systems for mandibular overdenture. A 5-year prospective randomised clinical study.Metalurgia International vol. XIV (2009) special issue no.16: 59-64

  RESULT

Study Officials

• CORINA MARILENA I CRISTACHE, DMD, PhD

  Concordia Dent Srl

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Corina Marilena Cristache, DMD, PhD, senior lecturer

Study Record Dates

• First Submitted: December 17, 2009
• First Posted: December 18, 2009
• Study Start: August 1, 2004
• Primary Completion: September 1, 2009
• Study Completion: December 1, 2012
• Last Updated: February 4, 2015

Record last verified: 2015-02

Locations

RO (1)