NCT Number: NCT07166224
Objective:
To compare three different oral hygiene regimens regarding plaque index (PI), bleeding on probing (BOP), the number of deepened periodontal pockets ≥4 mm (PPD), oral halitosis, and changes in oral health-related quality of life (OHRQoL) in an older population with periodontitis stage I-III and mild cognitive impairment.
1. Are there improvements in plaque index (PI), number of bleeding on probing (BOP) sites, number of probing depths (PPD), and intraoral halitosis in the two test groups compared to the control group? 2. Do the study interventions affect oral health-related quality of life in older adults with periodontitis and mild cognitive impairment?
Study design:
Type: Randomized controlled trial Duration: 6 months per participant, 2 years in total for data collection Participants: 90 participants divided into Intervention and Control groups
Intervention Group A (Lumoral Dual-Light aPDT + Manual Toothbrush) Standardized oral hygiene instructions and the use of a manual toothbrush during the test period, with an adjunctive aPDT device (Lumoral®).
Intervention Group B (Oral-B iO Powered Toothbrush) Standardized oral hygiene instructions and the use of an Oral-B iO powered toothbrush during the test period.
Control Group Standardized oral hygiene instructions and the use of a manual TePe Select extra soft toothbrush during the test period.
Trial opening soon.
Get Notified60 year and older
All sexes
Interventional
Not applicable
Karlskrona, Blekinge County, 371 79, Sweden
Evelina Klingborg PhD student
CONTACT
Evelina Klingborg, PhD student
SUB_INVESTIGATOR
Johan Flyborg, DDS PhD
PRINCIPAL_INVESTIGATOR
Johan Sanmartin Berglund Professor
CONTACT
Johan Sanmartin Berglund, Professor
SUB_INVESTIGATOR
Seida Erovic Ademovski, PhD
SUB_INVESTIGATOR
Stefan Renvert, Professor
SUB_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intervention Group B:
Participants receive standardized oral hygiene instructions and use an Oral-B iO powered toothbrush during the test period.
The Oral-B iO is an advanced powered toothbrush that combines oscillating-rotating and micro-vibrating bristle movements with real-time feedback technology. It is CE-marked for home use and designed to improve plaque removal and overall oral hygiene compared to manual toothbrushing. The device incorporates pressure sensors and guided brushing modes to support optimal brushing technique and patient adherence, which may contribute to improved periodontal outcomes.
Intervention Group A:
Participants receive standardized oral hygiene instructions and use only a manual toothbrush during the test period, with the addition of an adjunctive antimicrobial photodynamic therapy (aPDT) device (Lumoral®).
The Lumoral® treatment device is a CE-marked antibacterial device intended for home use. It is designed to support the treatment and prevention of oral diseases caused by bacterial biofilms. The device functions by emitting light at a specific wavelength, which activates a CE-marked photosensitizing mouthrinse, Lumorinse®. This light-activated process enhances antibacterial efficacy, targeting pathogenic microorganisms in the oral cavity and supporting improved oral hygiene outcomes.
Time frame: Assessments will be conducted at baseline, at 3 months, and at 6 months.
Assessment will be performed on all teeth at six sites per tooth. The plaque index (PI) will be reported as the percentage of sites with visible plaque, providing an estimate of the overall plaque accumulation on the teeth.
Time frame: Assessments will be conducted at baseline, at 3 months, and at 6 months.
A full-mouth assessment will be performed at six sites per tooth. Bleeding on probing (BOP) will be reported as the percentage of sites exhibiting bleeding.
Time frame: Assessments will be conducted at baseline, at 3 months, and at 6 months.
Pocket depth will be measured from the base of the pocket to the gingival margin at six sites per tooth. Probing pocket depths (PPD) of ≥4 mm will be recorded.
Time frame: Baseline
An 11-item cognitive assessment covering five domains: orientation, registration, attention and calculation, recall, and language. The maximum possible score is 30, with a score of 23 or lower indicating cognitive impairment.
Time frame: Assessments will be conducted at baseline, at 3 months, and at 6 months.
Volatile sulfur compounds (VSCs) in exhaled air will be measured using the OralChroma® device. The cutoff values are as follows: H₂S ≥112 ppb, CH₃SH ≥26 ppb, and (CH₃)₂S ≥8 ppb.
Time frame: Assessments will be conducted from baseline to 6 months.
Oral health-related quality of life will be assessed using the OHIP-14 (Oral Health Impact Profile-14) instrument. Scores range from 0 to 56, with lower scores indicating better oral health-related quality of life.
Blekinge Institute of Technology
Other
The Effect of Regular Home Use of Dual-light Antibacterial Photodynamic Therapy (aPDT) or the Use of a Powered Toothbrush in Older Individuals With Periodontitis and Mild Cognitive Impairment: a Randomized Controlled Trial.
Acronym: e-DENT II
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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