An interventional study of Powered toothbrush in Oral Health and Quality of Life, sponsored by Blekinge Institute of Technology. Completed at 2 sites in Sweden. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2023-07-11.
Sponsored by Blekinge Institute of Technology · Not applicable, Interventional, and Basic science
For this study, 213 individuals with Mild Cognitive Impairment were recruited. The study period ran from June 2018 to October 2021. The procedure involved a combined screening and baseline examination, including oral, medical, cognitive, and quality-of-life examinations. Re-examinations followed this at 6, 12, and 24 months. The examinations were performed at a university research clinic, and all participants received their usual medical and dental care during the study. At baseline, each participant received a powered toothbrush. Participants were carefully instructed on how to operate the powered toothbrush and were asked to brush for at least two minutes in the morning and evening. No restrictions were given against the use of other oral care products. Compliance with the powered toothbrush was followed by a participant survey conducted at each examination.. Facilitating and improving life by introducing a powered toothbrush as part of oral hygiene may benefit individuals with MCI. This study aimed to investigate whether the use of a powered toothbrush could maintain or improve oral health by reducing dental plaque (PI), bleeding on probing (BOP), and periodontal pocket depth (PPD)≥4mm in a group of individuals with MCI for an observation period of 24 months. Furthermore, to study how oral health changes affect QoL aspects.
3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.
This study's enrollment of 170 is above the median of 65 across 2,808 interventional studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →Blekinge Institute of Technology is the lead sponsor of 13 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
Device: Powered toothbrush
Oral-B Powered toothbrush
Change in the amount of dental plaque
Presence of dental plaque measured on four of the tooth surfaces presented as a percentage
Time frame: From baseline, to month 6, and to month 12, and to month 24, and to month 36
Change in the amount of gingival bleeding on probing
Number of bleeding from the gingiva measured on four sides of the teeth presented as a percentage
Time frame: From baseline, to month 6, and to month 12, and to month 24, and to month 36
Change in the number of periodontal pockets 4 mm or deeper
The number of periodontal pockets 4 mm or deeper measured on four of the tooth surfaces presented as a percentage
Time frame: From baseline, to month 6, and to month 12, and to month 24, and to month 36
Change in values for the quality of life instrument QoL-AD
The value for the quality of life instrument QoL-AD (Quality of Life Alzheimer Disease) is measured on a scale from 0-30, where 30 corresponds to the highest quality of life
Time frame: From baseline, to month 6, and to month 12, and to month 24, and to month 36
Change in values for the oral health related quality of life instrument OHIP-14
The value for the oral health-related quality of life instrument OHIP-14 (Oral Health Impact Profile-14) is measured on a scale from 0-56 where 0 corresponds to the highest quality of life
Time frame: From baseline, to month 6, and to month 12, and to month 24, and to month 36
Plan to share: Yes — The trial protocol and the datasets used and analyzed during the current study are available from the corresponding author upon reasonable request.
Supporting information: Study protocol
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Blekinge Institute of Technology