Alveolar Bone LossNCT03777748
Outcome of Implant-supported Overdentures
A study testing dental implants and stud attachments in people with Alveolar Bone Loss and Bone Resorption, run by RWTH Aachen University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Loss, Bone Resorption, Dental Implants
- What is being tested?
- dental implants and stud attachments
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2013to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
About this study
Official title: A Pilot Study to Clinically Evaluate Maxillary and Mandibular Overdentures Retained by Two Unsplinted Diameter-reduced Titanium-zirconium Implants
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.
Read the 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.
- Conditions
- Alveolar Bone Loss, Bone Resorption, Dental Implants, Edentulous Maxilla, Edentulous Patient
- Being tested
- dental implants and stud attachments
- Keywords
- Oral Health Impact Factor, Survival rate, Maxillary overdenture, Implant-Supported, Bone Resorption, Titanium-Zirconium, Anchor System
- Medical subject headings
- Alveolar Bone Loss, Bone Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dental implants and stud attachmentsDevice
Also called CM LOC® and CM LOC Flex® (Cendres+Métaux SA, Bienne), (sandblasted/acid-etched) SLActive® Roxolid® implants, Ø 3.3 mm (Straumann, Switzerland)
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: dental implants and stud attachments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigation of the success rates of the implants
Implant fracture, implant loss
Measured: 5 Years
Marginal bone loss
Measurement of marginal bone loss on standardized radiographs [mm]
Measured: 5 years
Secondary outcomes (7)
Probing depth
Measurement of probing depth [mm]
Measured: 5 Years
Gingival status
Assessment of gingival index
Measured: 5 Years
Oral hygiene
Assessment of plaque index
Measured: 5 Years
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.
Measured: 5 years
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".
Measured: 5 years
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.
Measured: 5 years
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2018
- Study start1 Jun 2013
- Primary completion1 Apr 2016
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Alveolar Bone LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Straumann AG
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03777748
- Sponsor's protocol ID
- UKA 373147
- Status last verified
- Mar 2020
- First submitted
- 6 Dec 2018
- Last updated
- 12 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 5278921Zembic 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.
PubMed 23581398Roccuzzo 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.
PubMed 23062145Kern 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.
PubMed 25664612Richter E, Knapp WJI. Auf zwei Eckzahnimplantaten abgestützte Oberkiefer-Coverdentureprothesen-Ergebnisse einer klinischen Studie. 2010;18:165-174.
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.
PubMed 27150942Al-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.
PubMed 21414131Chiapasco 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.
PubMed 22092806Passia 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.
PubMed 26705935Di 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.
PubMed 30269880Jordan 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.
PubMed 25547464Kern JS, Salin E, Elvers D, Rittich A, Tuna T, Holzle F, Wolfart S. Maxillary and mandibular overdentures retained by two unsplinted narrow-diameter titanium-zirconium implants - A clinical pilot study. Clin Oral Implants Res. 2024 Sep;35(9):1138-1150. doi: 10.1111/clr.14303. Epub 2024 Jun 1.
PubMed 38822688
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Clinically Evaluate Maxillary and Mandibular Overdentures Retained by Two Unsplinted Diameter-reduced Titanium-zirconium Implants
- ClinicalTrials.gov ID
- NCT03777748
- Acronym / sponsor ID
- UKA 373147
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Collaborators
- Institut Straumann AG
- Study start
- 1 Jun 2013 (actual)
- Primary completion
- 1 Apr 2016 (actual)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 17 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Two dental implants in the edentulous maxilla and mandible | Experimental | Device: dental implants and stud attachmentsEdentulous 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dental implants and stud attachmentsAlso: CM LOC® and CM LOC Flex® (Cendres+Métaux SA, Bienne), (sandblasted/acid-etched) SLActive® Roxolid® implants, Ø 3.3 mm (Straumann, Switzerland) | Device | Two dental implants in the edentulous maxilla and mandible |
Primary outcome
Investigation of the success rates of the implants
Time frame: 5 Years
Implant fracture, implant loss
Marginal bone loss
Time frame: 5 years
Measurement of marginal bone loss on standardized radiographs [mm]
7 secondary outcomes
Probing depth
Time frame: 5 Years
Gingival status
Time frame: 5 Years
Oral hygiene
Time frame: 5 Years
Oral Health Quality of Life
Time frame: 5 years
Chewing satisfaction
Time frame: 5 years
Masticatory performance
Time frame: 5 years
Survival rate of prosthetic restoration
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2020.
- Background: PubMed 5278921Murphy 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.
- Background: PubMed 23581398Zembic 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.
- Background: PubMed 23062145Roccuzzo 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.
- Background: PubMed 25664612Kern 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.
- BackgroundRichter E, Knapp WJI. Auf zwei Eckzahnimplantaten abgestützte Oberkiefer-Coverdentureprothesen-Ergebnisse einer klinischen Studie. 2010;18:165-174.
- Background: PubMed 27150942Zembic 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.
- Background: PubMed 21414131Al-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.
- Background: PubMed 22092806Chiapasco 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.
- Background: PubMed 26705935Passia 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.
- Background: PubMed 30269880Di 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.
- Background: PubMed 25547464Jordan 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.
- Derived from this study: PubMed 38822688Kern JS, Salin E, Elvers D, Rittich A, Tuna T, Holzle F, Wolfart S. Maxillary and mandibular overdentures retained by two unsplinted narrow-diameter titanium-zirconium implants - A clinical pilot study. Clin Oral Implants Res. 2024 Sep;35(9):1138-1150. doi: 10.1111/clr.14303. Epub 2024 Jun 1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing dental implants and stud attachments in people with Alveolar Bone Loss and Bone Resorption, run by RWTH Aachen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigation of the success rates of the implants (time frame: 5 Years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03777748, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2020.