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
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
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
NCT ID
NCT03777748
First Posted
December 6, 2018
Last Updated
March 10, 2020
Sponsor
RWTH Aachen University
Collaborators
Institut Straumann AG
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
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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
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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
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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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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.
Results Reference
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Outcome of Implant-supported Overdentures
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