Sponsor study identifier
interventional
12
1 country
1
Study Start
December 5, 2018
Actual (reported)Primary Completion
September 5, 2020
Actual (reported)Study Completion
September 30, 2020
Actual (reported)The aim of the study was to clinically and radiographically evaluate and compare the use of unsplinted and splinted short implants with ball abutments to support mandibular overdentures in cases with severe mandibular ridge resorption.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 30, 2020
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 5, 2018
Actual (reported)September 5, 2020
Actual (reported)September 30, 2020
Actual (reported)October 4, 2020
Actual (reported)October 9, 2020
Actual (reported)Implant stability
Stability was assessed using resonance frequency analysis measured with the Osstell device instrument. The Osstell unit records a numeric value of 1-100 which is referred to as the implant stability quotient (ISQ). The measurements were performed and 3 mean of three readings were recorded in each evaluation period.
up to 12 months
Peri-implant probing depth
Peri-implant probing depth refers to the distance between the gingival margin and the most apically probable portion in millimeters (mm). The peri-implant probing depth was measured using a graduated plastic periodontal probe. The probe was held parallel to the long axis of the implant and introduced to the peri-implant sulcus until slight resistance was felt. Measurements were made at four sites around each implant; buccal, lingual, mesial and distal. Probing depth of 1 mm or less was recorded as "1mm", and those exceeding 1 mm but less than 2 mm were recorded as "2mm" and so forth. The mean records for each implant were then calculated.
up to 12 months
Clinical attachment loss
It is the distance from the junction implant/abutment to the most apically probable portion, in millimeters. Assessment of the clinical attachment level was performed simultaneously while measuring the peri-implant probing depth.
up to 12 months
Gingival inflammation (Modified gingival index)
The peri-implant mucosal tissues around the implants were assessed using Apse's modification of Löe and Silness index. The criteria for assessment were: 0 =Normal mucosa, 1 =Mild inflammation, slight change in colour and texture, slight oedema and no bleeding on probing, 2 =Mild inflammation, redness, in all portions of gingival margin, 3 =Moderate inflammation, 4 =Severe inflammation. The gingival index was assessed at 4 sites around each implant (buccal, lingual, mesial and distal) the sum gingival index score was calculated from all these surfaces and then divided by 4 to obtain the gingival index for each implant. Indices of the three implants were added to each other, and then divided by 3 to get the mean gingival index for each case. A score from 0.1-1.0 reflects mild inflammation; 1.1-2.0 reflects moderate inflammation from, and 2.1-3.0 signifies severe inflammation.
Patients received ball abutments on each implant without splinting for retaining an implant retained mandibular overdenture.
Patients had their implants splinted using Rhein bars with ball extension for retaining an implant retained mandibular overdenture.
Faculty of Dentistry, Alexandria University
Alexandria, 21512, Egypt
Rocchietta I, Fontana F, Simion M. Clinical outcomes of vertical bone augmentation to enable dental implant placement: a systematic review. J Clin Periodontol. 2008 Sep;35(8 Suppl):203-15. doi: 10.1111/j.1600-051X.2008.01271.x.
Bell RB, Blakey GH, White RP, Hillebrand DG, Molina A. Staged reconstruction of the severely atrophic mandible with autogenous bone graft and endosteal implants. J Oral Maxillofac Surg. 2002 Oct;60(10):1135-41. doi: 10.1053/joms.2002.34986.
Ahmed Weheda, M.Sc
Faculty of Dentistry, Alexandria University, Egypt
Ahmed A Abdelhakim, PhD
Faculty of Dentistry, Alexandria University, Egypt
Magued H Fahmy, PhD
Faculty of Dentistry, Alexandria University, Egypt
Nermeen A Rady, PhD
Faculty of Dentistry, Alexandria University, Egypt
12 participants (actual enrollment reported by the registry).
First Submitted
October 4, 2020
First Posted
October 9, 2020
Study Start
December 5, 2018
Actual (reported)up to 12 months
Crestal bone loss
Mesial and Distal crestal bone loss were evaluated using digital periapical x-rays. In order to standardize the cones' and sensors' position and angulation, a film positioning system was used along with a customized silicone bite.
up to 12 months
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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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.
Annibali S, Cristalli MP, Dell'Aquila D, Bignozzi I, La Monaca G, Pilloni A. Short dental implants: a systematic review. J Dent Res. 2012 Jan;91(1):25-32. doi: 10.1177/0022034511425675. Epub 2011 Oct 27.
Baggi L, Cappelloni I, Di Girolamo M, Maceri F, Vairo G. The influence of implant diameter and length on stress distribution of osseointegrated implants related to crestal bone geometry: a three-dimensional finite element analysis. J Prosthet Dent. 2008 Dec;100(6):422-31. doi: 10.1016/S0022-3913(08)60259-0.
Bernard JP, Szmukler-Moncler S, Pessotto S, Vazquez L, Belser UC. The anchorage of Branemark and ITI implants of different lengths. I. An experimental study in the canine mandible. Clin Oral Implants Res. 2003 Oct;14(5):593-600. doi: 10.1034/j.1600-0501.2003.120908.x.
Stellingsma C, Meijer HJ, Raghoebar GM. Use of short endosseous implants and an overdenture in the extremely resorbed mandible: a five-year retrospective study. J Oral Maxillofac Surg. 2000 Apr;58(4):382-7; discussion 387-8. doi: 10.1016/s0278-2391(00)90917-0.
Primary Completion
September 5, 2020
Actual (reported)Study Completion
September 30, 2020
Actual (reported)Last Updated
December 4, 2023
Record last verified: 2023-12
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Source: ClinicalTrials.gov.
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