Dental ImplantsUKAConelogNCT03558347
CF41102 5-year Clinical Evaluation of Conelog® Implant With 7 mm Length
A study testing short implants with splinted crowns and short implants with non-splinted crowns in people with Dental Implants and Partial Edentulism, run by RWTH Aachen University at 1 site in Germany.
Trial summary
The objective of this prospective, randomized, pilot study is to determine whether the Conelog® connection is suitable for splinted/non-splinted cemented crowns in the chewing centre (focus only on implant-abutment connection) and whether implants with the Conelog® connection and a length of 7mm are suitable for use… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Implants, Partial Edentulism
- What is being tested?
- short implants with splinted crowns and short implants with non-splinted crowns
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2012to 27 Sep 2021
- 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
- absence of all molars and, optionally, the second premolar in at least on quadrant of the lower jaw
- the periodontal situation of the other teeth is healthy or periodontal treatment has already been successfully performed
- the antagonists are natural teeth or treated with fixed dentures
- good health according to the ASA Physical Status Classification System one or two (ASA 2010)
- good oral hygiene and an at most moderate tobacco consumption
- bone height above the N. alveolaris inferior of at least 11mm and the precondition of a one-stage implantation and augmentation
- signed consent
Who cannot join
- Indication for large augmentations of the jaw bone
- Bone abundance with minimal risk of injury to neighbouring structures when using two 11 mm or longer implants
- Psychological disorder
- substance abuse
- removable dentures (with or without implants)
- pregnancy
- patients under age or unable to reason
- persons who are placed in an institution on a judicial or administrative order
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universitätsklinikum Aachen
Aachen, North Rhine-Westphalia, 52072
About this study
Official title: 5 Year Clinical Evaluation of CONELOG® Screw-Line Implants With 7 mm Length: a Prospective Randomized Double-blinded Clinical Study
The objective of this prospective, randomized, pilot study is to determine whether the Conelog® connection is suitable for splinted/non-splinted cemented crowns in the chewing centre (focus only on implant-abutment connection) and whether implants with the Conelog® connection and a length of 7mm are suitable for use in the molar region of the lower jaw.
Read the detailed description
In order to avoid sinus augmentation in the upper jaw and a vertical augmentation in the lower jaw, various manufacturers offer short implants of 6-8mm length. The prevention of augmentative measures, especially in the mandible, is a fundamental component of the minimization of invasiveness while at the same time improving the functional capability. The benefit lies in the possibility to place implants without prior bone augmentation even in difficult anatomical conditions. This significantly reduces the invasiveness which on the one hand allows a higher number of patients to be treated with implants (especially morbid patients and anxiety patients) and on the other hand makes the treatment more predictable, with less risk, cost-efficient and considerably faster. Moreover, new scientific insights are gained in the area of short implants.
As with all implants, the risks associated with the study consist of intraoperative complications (e.g. damage of adjacent structures), failure of the implant (e.g. impairment of wound healing, fracture of the implant body), the abutment or abutment screw (e.g. loosening, fracture), or the crown on the abutment (veneer fracture, scaffold fracture).
The objective is to determine whether implants with the Conelog® connection and a length of 7mm are suitable for splinted/non-splinted monolithic lithium disilicate crowns cemented on individualized titanium abutments in the chewing centre of the mandible. The main indication for short implants is severe atrophy of the jaw, which creates a longer distance from the implant shoulder to the occlusal plane. An unfavourable crown-to-implant ratio means higher stress on the screws, the implant-abutment surface and possibly on the osseointegration of the implants. This raises the question whether splinted crowns have a positive effect on implant survival compared to non-splinted crowns.
The two 7mm Conelog ® implants are either used in the area of the second premolar and the first molar or the first and second molars of the mandible. The diameter of the implant depends on the width of the alveolar bone and ranges from 3.8 to 4.3 mm.
In case of a bilateral free-end situation, both quadrants are treated as part of the study, and both treatment variants are applied by using splinted crowns on one side and individual crowns on the other (split mouth design).
20 patients will be included in the study, which will be divided into two equally sized groups of 10 patients. All patients are recruited by the three clinical investigators at the Department of Prosthodontics and Biomaterials, Centre for Implantology, Medical Faculty, Rheinisch-Westfälische Technische Hochschule Aachen (RWTH) Aachen University Hospital. In order to achieve sufficient patient numbers, the population of Aachen will be informed via print media.
Each patient receives a single dose of antibiotics one hour prior to implant surgery. A mucoperiosteal flap was mobilized and the implants were placed as recommended by the manufacturer, using a surgical template as a guide. Healing abutments were screwed, and submerged healing is used for all implants. Second stage surgery is performed after 3 months. The prosthetic restoration is completed within 4 weeks after exposure.
Patients in group A will receive splinted monolithic lithium disilicate crowns cemented on individualized titanium abutments. Patients in group B will receive 2 non-splinted monolithic lithium disilicate-crowns cemented on individualized titanium abutments.
The cementation is done with Multilink Implant ® on the machined abutments, which have been cleaned for 5 minutes in an ultrasonic cleaner with 95% alcohol. The crowns are conditioned with hydrofluoric acid for 20 seconds and silanized with Monobond Plus® for 60 seconds. The day of insertion of the restoration is marked as baseline.
The examination performed at baseline and the follow up after 6 months includes occlusion, probing depth, plaque index and the condition of the ceramic surface of the crowns. Additionally, radiographs with customized positioning jigs are taken at baseline, after 1, 3, and 5 years.
- Conditions
- Dental Implants, Partial Edentulism
- Being tested
- short implants with splinted crowns, short implants with non-splinted crowns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
short implants with splinted crownsDevice
Also called CONELOG® Implant System
7 mm short implants (CONELOG® Implant System), individualized titanium abutments, splinted lithium disilicate crowns
short implants with non-splinted crownsDevice
Also called CONELOG® Implant System
7 mm short implants (CONELOG® Implant System), individualized titanium abutments, non-splinted lithium disilicate crowns
| Study group | Role | What they receive |
|---|---|---|
| short implants with splinted crowns | Experimental | Patients of that group received splinted crowns on the two adjacent implants Intervention: short implants with splinted crowns Receives: Device: short implants with splinted crowns |
| short implants with non-splinted crowns | Experimental | Patients of that group received single crowns on the two adjacent implants Intervention: short implants with non-splinted crowns Receives: Device: short implants with non-splinted crowns |
What is being measured
The primary outcome is the main question the study is designed to answer.
marginal bone loss
measurement of marginal bone loss on standardized radiographs [mm]
Measured: 5 years
Secondary outcomes (4)
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
survival rate of prosthetic restoration
screw loosening, screw fracture, implant fracture, chippings
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 posted15 Jun 2018
- Study start1 Mar 2012
- Primary completion27 Sep 2016
- Study completion27 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Dental ImplantsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study consists of 20 patients (15 female, 5 male, mean age 59) who, after implant placement and second stage surgery, are randomly divided into two groups: group A was treated with two splinted crowns, group B with non-splinted single crowns. Four patients with bilateral free-end situation received both splinted and non-splinted restorations.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Collaborators
- Camlog Oral Reconstruction Foundation
- Responsible party
- Sponsor
- Investigators
- Stefan Wolfart, Prof. Dr., Study director, University Hospital, Aachen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03558347
- Sponsor's protocol ID
- UKA 360569
- Acronym
- UKAConelog
- Status last verified
- Mar 2020
- First submitted
- 4 May 2018
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tawil G, Aboujaoude N, Younan R. Influence of prosthetic parameters on the survival and complication rates of short implants. Int J Oral Maxillofac Implants. 2006 Mar-Apr;21(2):275-82.
PubMed 16634499Misch CE. Short dental implants: a literature review and rationale for use. Dent Today. 2005 Aug;24(8):64-6, 68.
PubMed 16161821Vehemente VA, Chuang SK, Daher S, Muftu A, Dodson TB. Risk factors affecting dental implant survival. J Oral Implantol. 2002;28(2):74-81. doi: 10.1563/1548-1336(2002)0282.3.CO;2.
PubMed 12498449Gentile MA, Chuang SK, Dodson TB. Survival estimates and risk factors for failure with 6 x 5.7-mm implants. Int J Oral Maxillofac Implants. 2005 Nov-Dec;20(6):930-7.
PubMed 16392351Urdaneta RA, Rodriguez S, McNeil DC, Weed M, Chuang SK. The effect of increased crown-to-implant ratio on single-tooth locking-taper implants. Int J Oral Maxillofac Implants. 2010 Jul-Aug;25(4):729-43.
PubMed 20657868Li R, Sun W, Shi B. [Retrospective analysis of placing short dental implants in the posterior areas]. Zhonghua Kou Qiang Yi Xue Za Zhi. 2010 Dec;45(12):708-11. Chinese.
PubMed 21211233Yi YS, Emanuel KM, Chuang SK. Short (5.0 x 5.0 mm) implant placements and restoration with integrated abutment crowns. Implant Dent. 2011 Apr;20(2):125-30. doi: 10.1097/ID.0b013e31820fb67e.
PubMed 21448021Etoz OA, Ulu M, Kesim B. Treatment of patient with Papillon-Lefevre syndrome with short dental implants: a case report. Implant Dent. 2010 Oct;19(5):394-9. doi: 10.1097/ID.0b013e3181ed0798.
PubMed 20881810Ogawa T, Dhaliwal S, Naert I, Mine A, Kronstrom M, Sasaki K, Duyck J. Effect of tilted and short distal implants on axial forces and bending moments in implants supporting fixed dental prostheses: an in vitro study. Int J Prosthodont. 2010 Nov-Dec;23(6):566-73.
PubMed 21209995Wu H, Li JH, DI P, Qiu LX, Lin Y, Luo J. [A long-term retrospective clinical study of short dental implant restoration]. Zhonghua Kou Qiang Yi Xue Za Zhi. 2010 Dec;45(12):712-6. Chinese.
PubMed 21211234De Santis D, Cucchi A, Longhi C, Vincenzo B. Short threaded implants with an oxidized surface to restore posterior teeth: 1- to 3-year results of a prospective study. Int J Oral Maxillofac Implants. 2011 Mar-Apr;26(2):393-403.
PubMed 21483893Neldam CA, Pinholt EM. State of the art of short dental implants: a systematic review of the literature. Clin Implant Dent Relat Res. 2012 Aug;14(4):622-32. doi: 10.1111/j.1708-8208.2010.00303.x. Epub 2010 Oct 26.
PubMed 20977606Raviv E, Turcotte A, Harel-Raviv M. Short dental implants in reduced alveolar bone height. Quintessence Int. 2010 Jul-Aug;41(7):575-9.
PubMed 20614044Hasan I, Heinemann F, Aitlahrach M, Bourauel C. Biomechanical finite element analysis of small diameter and short dental implant. Biomed Tech (Berl). 2010 Dec;55(6):341-50. doi: 10.1515/BMT.2010.049. Epub 2010 Oct 28.
PubMed 21028950Al-Sawaf O, Tuna T, Rittich A, Kern T, Wolfart S. Randomized clinical trial evaluating the effect of splinting crowns on short implants in the mandible 3 years after loading. Clin Oral Implants Res. 2020 Nov;31(11):1061-1071. doi: 10.1111/clr.13652. Epub 2020 Sep 12.
PubMed 33463774
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 5 Year Clinical Evaluation of CONELOG® Screw-Line Implants With 7 mm Length: a Prospective Randomized Double-blinded Clinical Study
- ClinicalTrials.gov ID
- NCT03558347
- Acronym / sponsor ID
- UKAConelog / UKA 360569
- Conditions
- Dental Implants, Partial Edentulism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Collaborators
- Camlog Oral Reconstruction Foundation
- Study start
- 1 Mar 2012 (actual)
- Primary completion
- 27 Sep 2016 (actual)
- Study completion
- 27 Sep 2021 (estimated)
- First posted
- 15 Jun 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 objective of this prospective, randomized, pilot study is to determine whether the Conelog® connection is suitable for splinted/non-splinted cemented crowns in the chewing centre (focus only on implant-abutment connection) and whether implants with the Conelog® connection and a length of 7mm are suitable for use in the molar region of the lower jaw.
Detailed description
In order to avoid sinus augmentation in the upper jaw and a vertical augmentation in the lower jaw, various manufacturers offer short implants of 6-8mm length. The prevention of augmentative measures, especially in the mandible, is a fundamental component of the minimization of invasiveness while at the same time improving the functional capability. The benefit lies in the possibility to place implants without prior bone augmentation even in difficult anatomical conditions. This significantly reduces the invasiveness which on the one hand allows a higher number of patients to be treated with implants (especially morbid patients and anxiety patients) and on the other hand makes the treatment more predictable, with less risk, cost-efficient and considerably faster. Moreover, new scientific insights are gained in the area of short implants.
As with all implants, the risks associated with the study consist of intraoperative complications (e.g. damage of adjacent structures), failure of the implant (e.g. impairment of wound healing, fracture of the implant body), the abutment or abutment screw (e.g. loosening, fracture), or the crown on the abutment (veneer fracture, scaffold fracture).
The objective is to determine whether implants with the Conelog® connection and a length of 7mm are suitable for splinted/non-splinted monolithic lithium disilicate crowns cemented on individualized titanium abutments in the chewing centre of the mandible. The main indication for short implants is severe atrophy of the jaw, which creates a longer distance from the implant shoulder to the occlusal plane. An unfavourable crown-to-implant ratio means higher stress on the screws, the implant-abutment surface and possibly on the osseointegration of the implants. This raises the question whether splinted crowns have a positive effect on implant survival compared to non-splinted crowns.
The two 7mm Conelog ® implants are either used in the area of the second premolar and the first molar or the first and second molars of the mandible. The diameter of the implant depends on the width of the alveolar bone and ranges from 3.8 to 4.3 mm.
In case of a bilateral free-end situation, both quadrants are treated as part of the study, and both treatment variants are applied by using splinted crowns on one side and individual crowns on the other (split mouth design).
20 patients will be included in the study, which will be divided into two equally sized groups of 10 patients. All patients are recruited by the three clinical investigators at the Department of Prosthodontics and Biomaterials, Centre for Implantology, Medical Faculty, Rheinisch-Westfälische Technische Hochschule Aachen (RWTH) Aachen University Hospital. In order to achieve sufficient patient numbers, the population of Aachen will be informed via print media.
Each patient receives a single dose of antibiotics one hour prior to implant surgery. A mucoperiosteal flap was mobilized and the implants were placed as recommended by the manufacturer, using a surgical template as a guide. Healing abutments were screwed, and submerged healing is used for all implants. Second stage surgery is performed after 3 months. The prosthetic restoration is completed within 4 weeks after exposure.
Patients in group A will receive splinted monolithic lithium disilicate crowns cemented on individualized titanium abutments. Patients in group B will receive 2 non-splinted monolithic lithium disilicate-crowns cemented on individualized titanium abutments.
The cementation is done with Multilink Implant ® on the machined abutments, which have been cleaned for 5 minutes in an ultrasonic cleaner with 95% alcohol. The crowns are conditioned with hydrofluoric acid for 20 seconds and silanized with Monobond Plus® for 60 seconds. The day of insertion of the restoration is marked as baseline.
The examination performed at baseline and the follow up after 6 months includes occlusion, probing depth, plaque index and the condition of the ceramic surface of the crowns. Additionally, radiographs with customized positioning jigs are taken at baseline, after 1, 3, and 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study consists of 20 patients (15 female, 5 male, mean age 59) who, after implant placement and second stage surgery, are randomly divided into two groups: group A was treated with two splinted crowns, group B with non-splinted single crowns. Four patients with bilateral free-end situation received both splinted and non-splinted restorations.
| Arm | Type | Receives |
|---|---|---|
| short implants with splinted crowns | Experimental | Device: short implants with splinted crownsPatients of that group received splinted crowns on the two adjacent implants Intervention: short implants with splinted crowns |
| short implants with non-splinted crowns | Experimental | Device: short implants with non-splinted crownsPatients of that group received single crowns on the two adjacent implants Intervention: short implants with non-splinted crowns |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- female and male subjects older than 18 years
- absence of all molars and, optionally, the second premolar in at least on quadrant of the lower jaw
- the periodontal situation of the other teeth is healthy or periodontal treatment has already been successfully performed
- the antagonists are natural teeth or treated with fixed dentures
- good health according to the ASA Physical Status Classification System one or two (ASA 2010)
Key exclusion criteria (8 listed)
- Indication for large augmentations of the jaw bone
- Bone abundance with minimal risk of injury to neighbouring structures when using two 11 mm or longer implants
- Psychological disorder
- substance abuse
- removable dentures (with or without implants)
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 |
|---|---|---|
| short implants with splinted crownsAlso: CONELOG® Implant System7 mm short implants (CONELOG® Implant System), individualized titanium abutments, splinted lithium disilicate crowns | Device | short implants with splinted crowns |
| short implants with non-splinted crownsAlso: CONELOG® Implant System7 mm short implants (CONELOG® Implant System), individualized titanium abutments, non-splinted lithium disilicate crowns | Device | short implants with non-splinted crowns |
Primary outcome
marginal bone loss
Time frame: 5 years
measurement of marginal bone loss on standardized radiographs [mm]
4 secondary outcomes
probing depth
Time frame: 5 years
gingival status
Time frame: 5 years
oral hygiene
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 17 Mar 2020.
- Background: PubMed 16634499Tawil G, Aboujaoude N, Younan R. Influence of prosthetic parameters on the survival and complication rates of short implants. Int J Oral Maxillofac Implants. 2006 Mar-Apr;21(2):275-82.
- Background: PubMed 16161821Misch CE. Short dental implants: a literature review and rationale for use. Dent Today. 2005 Aug;24(8):64-6, 68.
- Background: PubMed 12498449Vehemente VA, Chuang SK, Daher S, Muftu A, Dodson TB. Risk factors affecting dental implant survival. J Oral Implantol. 2002;28(2):74-81. doi: 10.1563/1548-1336(2002)0282.3.CO;2.
- Background: PubMed 16392351Gentile MA, Chuang SK, Dodson TB. Survival estimates and risk factors for failure with 6 x 5.7-mm implants. Int J Oral Maxillofac Implants. 2005 Nov-Dec;20(6):930-7.
- Background: PubMed 20657868Urdaneta RA, Rodriguez S, McNeil DC, Weed M, Chuang SK. The effect of increased crown-to-implant ratio on single-tooth locking-taper implants. Int J Oral Maxillofac Implants. 2010 Jul-Aug;25(4):729-43.
- Background: PubMed 21211233Li R, Sun W, Shi B. [Retrospective analysis of placing short dental implants in the posterior areas]. Zhonghua Kou Qiang Yi Xue Za Zhi. 2010 Dec;45(12):708-11. Chinese.
- Background: PubMed 21448021Yi YS, Emanuel KM, Chuang SK. Short (5.0 x 5.0 mm) implant placements and restoration with integrated abutment crowns. Implant Dent. 2011 Apr;20(2):125-30. doi: 10.1097/ID.0b013e31820fb67e.
- Background: PubMed 20881810Etoz OA, Ulu M, Kesim B. Treatment of patient with Papillon-Lefevre syndrome with short dental implants: a case report. Implant Dent. 2010 Oct;19(5):394-9. doi: 10.1097/ID.0b013e3181ed0798.
- Background: PubMed 21209995Ogawa T, Dhaliwal S, Naert I, Mine A, Kronstrom M, Sasaki K, Duyck J. Effect of tilted and short distal implants on axial forces and bending moments in implants supporting fixed dental prostheses: an in vitro study. Int J Prosthodont. 2010 Nov-Dec;23(6):566-73.
- Background: PubMed 21211234Wu H, Li JH, DI P, Qiu LX, Lin Y, Luo J. [A long-term retrospective clinical study of short dental implant restoration]. Zhonghua Kou Qiang Yi Xue Za Zhi. 2010 Dec;45(12):712-6. Chinese.
- Background: PubMed 21483893De Santis D, Cucchi A, Longhi C, Vincenzo B. Short threaded implants with an oxidized surface to restore posterior teeth: 1- to 3-year results of a prospective study. Int J Oral Maxillofac Implants. 2011 Mar-Apr;26(2):393-403.
- Background: PubMed 20977606Neldam CA, Pinholt EM. State of the art of short dental implants: a systematic review of the literature. Clin Implant Dent Relat Res. 2012 Aug;14(4):622-32. doi: 10.1111/j.1708-8208.2010.00303.x. Epub 2010 Oct 26.
- 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.
Stefan Wolfart, Prof. Dr. study director
University Hospital, Aachen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing short implants with splinted crowns and short implants with non-splinted crowns in people with Dental Implants and Partial Edentulism, run by RWTH Aachen University at 1 site in Germany.
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 8 inclusion and 8 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 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
marginal bone loss (time frame: 5 years). 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 NCT03558347, which also lists 15 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 17 Mar 2020; AzTrials last refreshed its copy on 8 Nov 2026.