CF41102 5-year Clinical Evaluation of Conelog® Implant With 7 mm Length

NCT03558347 | Unknown

• 1 other identifier: UKA 360569
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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 in the molar region of the lower jaw.

Conditions

Dental Implants; Partial Edentulism

Outcome Measures

Primary Outcomes (1)

• marginal bone loss

  measurement of marginal bone loss on standardized radiographs \[mm\]

  5 years

Secondary Outcomes (4)

• probing depth

  5 years

• gingival status

  5 years

• oral hygiene

  5 years

• survival rate of prosthetic restoration

  5 years

Study Arms (2)

short implants with splinted crowns

EXPERIMENTAL

Patients of that group received splinted crowns on the two adjacent implants Intervention: short implants with splinted crowns

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

Device: short implants with non-splinted crowns

Interventions

short implants with splinted crowns DEVICE

7 mm short implants (CONELOG® Implant System), individualized titanium abutments, splinted lithium disilicate crowns

Also known as: CONELOG® Implant System

short implants with splinted crowns

short implants with non-splinted crowns DEVICE

7 mm short implants (CONELOG® Implant System), individualized titanium abutments, non-splinted lithium disilicate crowns

Also known as: CONELOG® Implant System

short implants with non-splinted crowns

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• RWTH Aachen University: lead
• Camlog Oral Reconstruction Foundation: collaborator

Study Sites (1)

Universitätsklinikum Aachen

Aachen, North Rhine-Westphalia, 52072, Germany

Location

Related Publications (15)

• 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.

  PMID: 16634499 BACKGROUND

• Misch CE. Short dental implants: a literature review and rationale for use. Dent Today. 2005 Aug;24(8):64-6, 68.

  PMID: 16161821 BACKGROUND

• 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.

  PMID: 12498449 BACKGROUND

• 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.

  PMID: 16392351 BACKGROUND

• 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.

  PMID: 20657868 BACKGROUND

• 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.

  PMID: 21211233 BACKGROUND

• 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.

  PMID: 21448021 BACKGROUND

• 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.

  PMID: 20881810 BACKGROUND

• 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.

  PMID: 21209995 BACKGROUND

• 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.

  PMID: 21211234 BACKGROUND

• 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.

  PMID: 21483893 BACKGROUND

• 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.

  PMID: 20977606 BACKGROUND

• Raviv E, Turcotte A, Harel-Raviv M. Short dental implants in reduced alveolar bone height. Quintessence Int. 2010 Jul-Aug;41(7):575-9.

  PMID: 20614044 BACKGROUND

• 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.

  PMID: 21028950 BACKGROUND

• 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.

  PMID: 33463774 DERIVED

Study Officials

• Stefan Wolfart, Prof. Dr.

  University Hospital, Aachen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 4, 2018
• First Posted: June 15, 2018
• Study Start: March 1, 2012
• Primary Completion: September 27, 2016
• Study Completion: September 27, 2021
• Last Updated: March 17, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)