Comparative Clinical and Radiographic Study of Mandibular Overdentures Immediately Loaded on Implants or Mini-implants Randomized Control Trial
Sponsor study identifier
interventional
36
1 country
1
Study Start
April 3, 2019
Actual (reported)Primary Completion
June 20, 2021
Actual (reported)Study Completion
December 12, 2022
Actual (reported)3 groups of immediately Loaded implant-supported overdenture patients will be evaluated (overdentures supported by two standard-sized implant, overdentures supported by 4 mini implant d: 3.2 mm ,overdentures supported by 4 mini implant d: 2.75 mm) regarding stability, masticatory efficiency, patient's satisfaction, oral health related quality of life, Peri-implant crestal alveolar bone loss.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 12, 2022
Actual (reported)Click on a node to explore related trials.
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.
March 2, 2019
Actual (reported)March 7, 2019
Actual (reported)April 3, 2019
Actual (reported)June 20, 2021
Actual (reported)December 12, 2022
Actual (reported)change in denture stability
The evaluation will be by Digital force gauge, a Hook of orthodontic wire (18 gauge diameter) will attach to the labial flange of overdenture, the other end of wire will connect to the force gauge which will be pull vertically upward until denture retention lost, and then reading will record 3 times and means value will calculate.
T1: before implantation; T2: 1 month after loaded; T3: 3 month after loaded; T4: 6 month after loaded; T5:12 month after loaded
change in masticatory efficiency
The evaluation will be by test food filtering device,Where the subjects will chew a measured portion of test food (peanuts) for 20 strokes. The test food will strain through mesh sieve (2 mm opening). The volume of food remaining on the sieve and that passing through the sieve determined the masticatory performance.
T1: before implantation; T2: 1 month after loaded; T3: 3 month after loaded; T4: 6 month after loaded; T5:12 month after loaded
change in patient's satisfaction
The evaluation will be by 100 mm Visual Analog Scale (VAS), for which higher scores indicate greater satisfaction, They will be asked to rate their level of comfort, ability to chew, stability, ability to speak, ease of cleaning their prostheses and their general satisfaction.
T1: before implantation; T2: 1 month after loaded; T3: 3 month after loaded; T4: 6 month after loaded; T5:12 month after loaded
change in oral health related quality of life
The evaluation will be by oral health impact profile of edentulous (Ohip-Edent) instrument, Patients will answer questions of ohip-edent which included 7 domains: functional limitation, physical pain, psychological discomfort, physical disability, Psychological disability, Social disability, Handicap. Responses will made on a five-grade Likert-type scale: 0=never ; 1=hardly ever ; 2=occasionally ; 3= fairly often ; 4= very often. disability, social disability and handicap
12 Patients will be provided with 4 mini implant-supported mandibular overdentures d: 2.75 mm
12 Patients will be provided with 4 mini implant-supported mandibular overdentures d: 3.25 mm
12 Patients will be provided with 2 standard sized implant-supported mandibular overdentures d: 3.75 mm
The implant-supported overdentures will be placed in immediate functional loading on the same day of implants placement. A direct restorative protocol will be applied to modify the existing prosthesis to implant-supported overdentures.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Removable prosthodontics department and implantation department / Faculty of dental medicine / Damascus univ
Damascus, Syria
Zygogiannis K, Aartman IH, Parsa A, Tahmaseb A, Wismeijer D. Implant Mandibular Overdentures Retained by Immediately Loaded Implants: A 1-Year Randomized Trial Comparing the Clinical and Radiographic Outcomes Between Mini Dental Implants and Standard-Sized Implants. Int J Oral Maxillofac Implants. 2017 Nov/Dec;32(6):1377-1388. doi: 10.11607/jomi.5981.
Kanazawa M, Tanoue M, Miyayasu A, Takeshita S, Sato D, Asami M, Lam TV, Thu KM, Oda K, Komagamine Y, Minakuchi S, Feine J. The patient general satisfaction of mandibular single-implant overdentures and conventional complete dentures: Study protocol for a randomized crossover trial. Medicine (Baltimore). 2018 May;97(20):e10721. doi: 10.1097/MD.0000000000010721.
Heba M Moftah, DDS MSc
PhD student at Removable Prosthodontics Department, faculty of dental medicine, Damascus Univ
Mohannad H Al-saadi, DDS MSc PhD
Professor of Removable Prosthodontics, faculty of dental medicine, Damascus Univ
Khaldoun A Darwich, DDS Msc PhD
Professor of Oral and Maxillofacial surgery, faculty of dental medicine, Damascus Univ
36 participants (actual enrollment reported by the registry).
First Submitted
March 2, 2019
First Posted
March 7, 2019
Study Start
April 3, 2019
Actual (reported)T1: before implantation; T2: 1 month after loaded; T3: 3 month after loaded; T4: 6 month after loaded; T5:12 month after loaded
change in Peri-implant crestal alveolar bone loss
The evaluation will be by panoramic radiogram, Peri-implant vertical and horizontal alveolar bone loss will measure (in mm) at the mesial and distal surface of each implant. implant
T1: on same day of loaded; T2: 3 month after loaded; T3: 6 month after loaded; T4:12 month after loaded
Contact the study team to confirm eligibility.
ALHarthi SS, BinShabaib MS, Ahmed HB, Mehmood A, Khan J, Javed F. Comparison of peri-implant clinical and radiographic inflammatory parameters among cigarette and waterpipe (narghile) smokers and never-smokers. J Periodontol. 2018 Feb;89(2):213-218. doi: 10.1902/jop.2017.170358.
Kappel S, Giannakopoulos NN, Eberhard L, Rammelsberg P, Eiffler C. Immediate Loading of Dental Implants in Edentulous Mandibles by Use of Locator(R) Attachments or Dolder(R) Bars: Two-Year Results from a Prospective Randomized Clinical Study. Clin Implant Dent Relat Res. 2016 Aug;18(4):752-61. doi: 10.1111/cid.12349. Epub 2015 May 7.
Kroll P, Hou L, Radaideh H, Sharifi N, Han PP, Mulligan R, Enciso R. Oral Health-Related Outcomes in Edentulous Patients Treated With Mandibular Implant-Retained Dentures Versus Complete Dentures: Systematic Review With Meta-Analyses. J Oral Implantol. 2018 Aug;44(4):313-324. doi: 10.1563/aaid-joi-D-17-00210. Epub 2018 Feb 19.
Primary Completion
June 20, 2021
Actual (reported)Study Completion
December 12, 2022
Actual (reported)Last Updated
February 9, 2023
Record last verified: 2023-02
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: