NCT06096753|Unknown
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Sponsor study identifier
observational
20
0 countries
N/A
Study Start
November 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
April 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This study aims to compare the gnathological function of edentulous patient rehabilitated according to the full-arch method (Columbus Bridge Protocol™) with immediate loading with that of dentate patients, through at-home night-time monitoring with Bruxoff® device.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 17, 2023
Actual (reported)October 24, 2023
Actual (reported)November 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Masseter contractions
Number and type of masseter contractions (tonic/phasic/mixed)
Night 1, Night 2, Night 3
Bruxism episodes
Number of possible episodes of nocturnal bruxism in total and per hour of sleep
Night 1, Night 2, Night 3
Heart rate
Average heart rate
Night 1, Night 2, Night 3
The Test Group will include patients rehabilitated according to the full-arch method (Columbus Bridge ProtocolTM) with immediate loading for at least 6 months prior to the first nocturnal recording using Bruxoff®.
The Control Group will include healthy subjects and volunteers awaiting implant-prosthetic rehabilitation of intercalated edentulism (i.e. single-tooth gap) who have natural dentition up to the first molar.
The recordings will be carried out for 3 randomly selected nights within 3 weeks, with at least 4 hours of sleep per night.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The subjects to be included in the study will be chosen from the list of patients rehabilitated according to the immediate-loading full-arch method (Columbus Bridge Protocol™) at the SCDU of Oral Rehabilitation, Maxillofacial Prosthetics and Dental Implantology (University of Turin) (Test Group) and from the list of subjects waiting for implant-prosthetic rehabilitation of intercalated edentulism (i.e. single-tooth implant) (Control Group). The subjects of the Control Group will be matched with a 1:1 ratio for the variables sex and age (±5 years) to the patients of the Test Group. Given the nature of the study (i.e. pilot study), the calculation of the sample size was not possible in the planning phase of the study. However, based on the evidence obtained from similar studies(7), 10 subjects per group are considered sufficient to test this method.
Howe MS, Keys W, Richards D. Long-term (10-year) dental implant survival: A systematic review and sensitivity meta-analysis. J Dent. 2019 May;84:9-21. doi: 10.1016/j.jdent.2019.03.008. Epub 2019 Mar 20.
Pera P, Menini M, Pesce P, Bevilacqua M, Pera F, Tealdo T. Immediate Versus Delayed Loading of Dental Implants Supporting Fixed Full-Arch Maxillary Prostheses: A 10-year Follow-up Report. Int J Prosthodont. 2019 Jan/Feb;32(1):27-31. doi: 10.11607/ijp.5804.
Francesco Pera, Prof.
University of Turin, Italy
First Submitted
October 17, 2023
First Posted
October 24, 2023
Study Start
November 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
April 2025
Contact the study team to confirm eligibility.
Dellepiane E, Pera F, Zunino P, Mugno MG, Pesce P, Menini M. Oral Health-Related Quality of Life and Full-Arch Immediate Loading Rehabilitation: An Evaluation of Preoperative, Intermediate, and Posttreatment Assessments of Patients Using a Modification of the OHIP Questionnaire. J Oral Implantol. 2020 Dec 1;46(6):540-549. doi: 10.1563/aaid-joi-D-19-00274.
Pesce P, Menini M, Furnari M, Pera F, Tealdo T, Pera P. Gastric and masticatory performances in full-arch immediate loading rehabilitated patients. J Oral Rehabil. 2015 Sep;42(9):663-9. doi: 10.1111/joor.12301. Epub 2015 Apr 16.
Tealdo T, Bevilacqua M, Menini M, Pera F, Ravera G, Drago C, Pera P. Immediate versus delayed loading of dental implants in edentulous maxillae: a 36-month prospective study. Int J Prosthodont. 2011 Jul-Aug;24(4):294-302.
Deregibus A, Castroflorio T, Bargellini A, Debernardi C. Reliability of a portable device for the detection of sleep bruxism. Clin Oral Investig. 2014 Nov;18(8):2037-43. doi: 10.1007/s00784-013-1168-z. Epub 2013 Dec 28.
Castroflorio T, Deregibus A, Bargellini A, Debernardi C, Manfredini D. Detection of sleep bruxism: comparison between an electromyographic and electrocardiographic portable holter and polysomnography. J Oral Rehabil. 2014 Mar;41(3):163-9. doi: 10.1111/joor.12131. Epub 2014 Jan 7.
Saczuk K, Lapinska B, Wilmont P, Pawlak L, Lukomska-Szymanska M. The Bruxoff Device as a Screening Method for Sleep Bruxism in Dental Practice. J Clin Med. 2019 Jun 28;8(7):930. doi: 10.3390/jcm8070930.
Shimada A, Castrillon EE, Svensson P. Revisited relationships between probable sleep bruxism and clinical muscle symptoms. J Dent. 2019 Mar;82:85-90. doi: 10.1016/j.jdent.2019.01.013. Epub 2019 Feb 1.
Lobbezoo F, Ahlberg J, Raphael KG, Wetselaar P, Glaros AG, Kato T, Santiago V, Winocur E, De Laat A, De Leeuw R, Koyano K, Lavigne GJ, Svensson P, Manfredini D. International consensus on the assessment of bruxism: Report of a work in progress. J Oral Rehabil. 2018 Nov;45(11):837-844. doi: 10.1111/joor.12663. Epub 2018 Jun 21.
Bertazzo-Silveira E, Kruger CM, Porto De Toledo I, Porporatti AL, Dick B, Flores-Mir C, De Luca Canto G. Association between sleep bruxism and alcohol, caffeine, tobacco, and drug abuse: A systematic review. J Am Dent Assoc. 2016 Nov;147(11):859-866.e4. doi: 10.1016/j.adaj.2016.06.014. Epub 2016 Aug 10.
Mizumori T, Sumiya M, Kobayashi Y, Inano S, Yatani H. Prediction of sleep bruxism events by increased heart rate. Int J Prosthodont. 2013 May-Jun;26(3):239-43. doi: 10.11607/ijp.3305.
Farina D, Cescon C. Concentric-ring electrode systems for noninvasive detection of single motor unit activity. IEEE Trans Biomed Eng. 2001 Nov;48(11):1326-34. doi: 10.1109/10.959328.
Berglundh T, Armitage G, Araujo MG, Avila-Ortiz G, Blanco J, Camargo PM, Chen S, Cochran D, Derks J, Figuero E, Hammerle CHF, Heitz-Mayfield LJA, Huynh-Ba G, Iacono V, Koo KT, Lambert F, McCauley L, Quirynen M, Renvert S, Salvi GE, Schwarz F, Tarnow D, Tomasi C, Wang HL, Zitzmann N. Peri-implant diseases and conditions: Consensus report of workgroup 4 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Clin Periodontol. 2018 Jun;45 Suppl 20:S286-S291. doi: 10.1111/jcpe.12957.
Tonetti MS, Greenwell H, Kornman KS. Staging and grading of periodontitis: Framework and proposal of a new classification and case definition. J Periodontol. 2018 Jun;89 Suppl 1:S159-S172. doi: 10.1002/JPER.18-0006.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 24, 2023
Record last verified: 2023-10
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