CF41102 5-year Clinical Evaluation of Conelog® Implant With 7 mm Length
NCT ID: NCT03558347
Last Updated: 2020-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2012-03-01
2021-09-27
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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short implants with splinted crowns
Patients of that group received splinted crowns on the two adjacent implants Intervention: short implants with splinted crowns
short implants with splinted crowns
7 mm short implants (CONELOG® Implant System), individualized titanium abutments, splinted lithium disilicate crowns
short implants with non-splinted crowns
Patients of that group received single crowns on the two adjacent implants Intervention: short implants with non-splinted crowns
short implants with non-splinted crowns
7 mm short implants (CONELOG® Implant System), individualized titanium abutments, non-splinted lithium disilicate crowns
Interventions
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short implants with splinted crowns
7 mm short implants (CONELOG® Implant System), individualized titanium abutments, splinted lithium disilicate crowns
short implants with non-splinted crowns
7 mm short implants (CONELOG® Implant System), individualized titanium abutments, non-splinted lithium disilicate crowns
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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Camlog Oral Reconstruction Foundation
OTHER
RWTH Aachen University
OTHER
Responsible Party
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Principal Investigators
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Stefan Wolfart, Prof. Dr.
Role: STUDY_DIRECTOR
University Hospital, Aachen
Locations
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Universitätsklinikum Aachen
Aachen, North Rhine-Westphalia, Germany
Countries
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References
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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.
Misch CE. Short dental implants: a literature review and rationale for use. Dent Today. 2005 Aug;24(8):64-6, 68.
Vehemente 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.
Gentile 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.
Urdaneta 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.
Li 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.
Yi 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.
Etoz 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.
Ogawa 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.
Wu 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.
De 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.
Neldam 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.
Raviv E, Turcotte A, Harel-Raviv M. Short dental implants in reduced alveolar bone height. Quintessence Int. 2010 Jul-Aug;41(7):575-9.
Hasan 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.
Al-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.
Other Identifiers
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UKA 360569
Identifier Type: -
Identifier Source: org_study_id
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