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Outcome of Implant-supported Overdentures

Primary Purpose

Alveolar Bone Loss, Bone Resorption, Dental Implants

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
dental implants and stud attachments
Sponsored by
RWTH Aachen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alveolar Bone Loss focused on measuring Oral Health Impact Factor, Survival rate, Maxillary overdenture, Implant-Supported, Bone Resorption, Titanium-Zirconium, Anchor System

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Two dental implants in the edentulous maxilla and mandible

    Arm Description

    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).

    Outcomes

    Primary Outcome Measures

    Investigation of the success rates of the implants
    Implant fracture, implant loss
    Marginal bone loss
    Measurement of marginal bone loss on standardized radiographs [mm]

    Secondary Outcome Measures

    Probing depth
    Measurement of probing depth [mm]
    Gingival status
    Assessment of gingival index
    Oral hygiene
    Assessment of plaque index
    Oral Health Quality of Life
    Oral Health Impact Profile - G14 (OHIP-G14, short version of the OHIP with 14 questions, according to Slade). Responses are made on a scale of never (0), hardly (1), occasionally (2), fairly often (3) and very often (4), resulting in possible values from 0 to 56 points in total.
    Chewing satisfaction
    Assessment of the chewing satisfaction using a Visual Analogue Scale (VAS). The beginning of the scale is defined as "completely dissatisfied" and the end of the line as "completely satisfied".
    Masticatory performance
    Assessment of the masticatory performance with a standardized chewing test. The participants are instructed to chew standardised gums with three degrees of hardness for 30 seconds each on the right and left sides as well as on both sides. The chewed particles were then spread to a standardized detection sheet. Each sheet is placed in a standardized stand support and are photographed.
    Survival rate of prosthetic restoration
    The prosthesis is examined for cracks, fractures, discolorations or other defects. Pass accuracy is examined. Visual and tactile control of the CM LOC® abutments and of the matrices (with retention inserts) are done.

    Full Information

    First Posted
    December 6, 2018
    Last Updated
    March 10, 2020
    Sponsor
    RWTH Aachen University
    Collaborators
    Institut Straumann AG
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03777748
    Brief Title
    Outcome of Implant-supported Overdentures
    Official Title
    A Pilot Study to Clinically Evaluate Maxillary and Mandibular Overdentures Retained by Two Unsplinted Diameter-reduced Titanium-zirconium Implants
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 1, 2013 (Actual)
    Primary Completion Date
    April 1, 2016 (Actual)
    Study Completion Date
    December 30, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    RWTH Aachen University
    Collaborators
    Institut Straumann AG

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    According to the recent German Oral Health Study (DMS V), toothlessness is still frequently represented in the German population. Thus in the group of 65 to 74 years old 12.4% were edentulous. Whereas in the group of 75 to 100 years old 32.8% were toothless. Toothlessness occurred more frequently in the upper jaw (19,8%) than in the lower jaw (13,7%). Although maxillary complete dentures show less retention problems than mandibular complete dentures, edentulous patients often wish prosthesis without a palatal coverage. Since the palate is not covered by the prosthesis, the taste sense will not be affected. Zembic et al. show a significantly higher patient satisfaction for esthetics (mean difference 8.8 mm ± 24.6) and taste (mean difference 28.4 mm ± 29.9) without palatal coverage. To prevent a palatal coverage at least four implants in the upper jaw are recommended. A systematic review concluded that implant loss rates for maxillary overdentures on two implants were significantly higher than for four implants. The recommendation to place more than two implants in the edentulous maxilla is also based on the results of a study by Richter and Knapp. Richter et al. detected very low survival rates for two implants and various anchoring elements in the edentulous upper jaw after mean observation time of five years. The 15 patients received diameter-reduced (3.25 mm) implants in the canine area. The implants were not parallel to each other due to anatomical limitations. The prostheses were attached either with telescopes or locator attachments. The implant survival rate was 39% for telescope attachments and 14% for locator attachments. The study resulted in high amount of implant fractures. In contrast, a recent study of Zembic et al. concluded an implant survival rate of 97.3% (1 year), for maxillary overdentures supported by 2 titanium-zirconium implants. However, the systematic review and meta-Analysis from Di Francesco et al. also verifies the lack of evidence concerning the number of implants in the edentulous maxilla and the relationship between overdenture survival and the patient's quality of life. In the planned observation study, the investigators also used diameter-reduced (3.3 mm) implants. Similarly in the study before the investigators selected a titanium-zirconium (TiZr) implant called Roxolid® (Straumann) to prevent high rate of implant fracture. According to several previous studies the TiZr small-diameter bone level implants provide at least the same outcomes after 12 month as titanium Grade IV bone level implants. The implant survival and success rates were 100% for TiZr implants.These promising results were first indications for an improved mechanical property of TiZr implants which may extend implant therapy to more challenging clinical situations, as discussed before for edentulous maxilla. In addition, the investigators use a new anchoring system called CM LOC® and CM LOC Flex® to compensate different implant angulation. CM LOC Flex® anchor system offers the special advantage of a broad range of clinical applications due to its unique compensation function. The abutment can be angled up to 60°, which significantly reduce the wear between female part and titanium patrix. There is already an in vitro study by Passia et al., demonstrating positive long-term retention behaviour for CM LOC® in comparison to Locator anchor. In the actual study the investigators included ten maxillary and mandible edentulous patients (58-79 years old) being dissatisfied with their complete dentures. In total, 40 diameter-reduced titanium-zirconium implants were placed in the canine region of the upper and lower jaw. Following 3 to 5 months of healing, implant-supported overdentures were inserted on two CM LOC® and CM LOC Flex® attachments depending on the indication. Implants and overdentures were evaluated at 4 weeks (baseline) and 6, 12, 24, 36 months after insertion of overdentures. Standardized radiographs were taken at implant loading and 12, 36 month after loading. Implant survival rates and bone loss were the primary outcomes. The oral health related quality of life was assessed before and after treatment by means of the questionnaires OHIP G14. Further, each patient completed an additional questionnaire to evaluate chewing satisfaction for soft and hard foods. Questions were answered on a 100-mm visual analogue scale (VAS). Additionally, the masticatory performance was assessed with a standardized chewing test. The participants were instructed to chew standardised gums with three degrees of hardness for 30 seconds, each on the right and left side as well as on both sides. The chewed particles were then spread to a standardized detection sheet. Each sheet is placed in a tripod, and photos were made. Chewing efficacy was obtained before treatment, at baseline, 6, 12, 24, 36 month after implant loading. Descriptive statistics were applied by calculating means, medians, standard deviations, and interquartile ranges of bone loss and of the questionnaires. Bone loss and the questionnares were statistically assessed using the Wilcoxon signed rank test. The level of significance was set at 5%. The evaluation of the standardized masticatory function test was performed automatically through the use of a light sensor that measures the size and amounts of chewed particles.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Two dental implants in the edentulous maxilla and mandible
    Arm Type
    Experimental
    Arm Description
    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).
    Intervention Type
    Device
    Intervention Name(s)
    dental implants and stud attachments
    Other Intervention Name(s)
    CM LOC® and CM LOC Flex® (Cendres+Métaux SA, Bienne), (sandblasted/acid-etched) SLActive® Roxolid® implants, Ø 3.3 mm (Straumann, Switzerland)
    Primary Outcome Measure Information:
    Title
    Investigation of the success rates of the implants
    Description
    Implant fracture, implant loss
    Time Frame
    5 Years
    Title
    Marginal bone loss
    Description
    Measurement of marginal bone loss on standardized radiographs [mm]
    Time Frame
    5 years
    Secondary Outcome Measure Information:
    Title
    Probing depth
    Description
    Measurement of probing depth [mm]
    Time Frame
    5 Years
    Title
    Gingival status
    Description
    Assessment of gingival index
    Time Frame
    5 Years
    Title
    Oral hygiene
    Description
    Assessment of plaque index
    Time Frame
    5 Years
    Title
    Oral Health Quality of Life
    Description
    Oral Health Impact Profile - G14 (OHIP-G14, short version of the OHIP with 14 questions, according to Slade). Responses are made on a scale of never (0), hardly (1), occasionally (2), fairly often (3) and very often (4), resulting in possible values from 0 to 56 points in total.
    Time Frame
    5 years
    Title
    Chewing satisfaction
    Description
    Assessment of the chewing satisfaction using a Visual Analogue Scale (VAS). The beginning of the scale is defined as "completely dissatisfied" and the end of the line as "completely satisfied".
    Time Frame
    5 years
    Title
    Masticatory performance
    Description
    Assessment of the masticatory performance with a standardized chewing test. The participants are instructed to chew standardised gums with three degrees of hardness for 30 seconds each on the right and left sides as well as on both sides. The chewed particles were then spread to a standardized detection sheet. Each sheet is placed in a standardized stand support and are photographed.
    Time Frame
    5 years
    Title
    Survival rate of prosthetic restoration
    Description
    The prosthesis is examined for cracks, fractures, discolorations or other defects. Pass accuracy is examined. Visual and tactile control of the CM LOC® abutments and of the matrices (with retention inserts) are done.
    Time Frame
    5 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    5278921
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    23581398
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    23062145
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    25664612
    Citation
    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.
    Results Reference
    background
    Citation
    Richter E, Knapp WJI. Auf zwei Eckzahnimplantaten abgestützte Oberkiefer-Coverdentureprothesen-Ergebnisse einer klinischen Studie. 2010;18:165-174.
    Results Reference
    background
    PubMed Identifier
    27150942
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    21414131
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    22092806
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    26705935
    Citation
    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.
    Results Reference
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    PubMed Identifier
    30269880
    Citation
    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.
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    PubMed Identifier
    25547464
    Citation
    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.
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    Outcome of Implant-supported Overdentures

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