Trial · NCT07054645
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Cognitive Function Assessed by MoCA (Montreal Cognitive Assessment) Score | Baseline and Week 6 | The MoCA score (0-30) will be used to assess global cognitive function. A higher score indicates better cognitive performance. Measurements will be taken at baseline and at 6 weeks. |
| Secondary | Change in Executive Function Assessed by Stroop Test | Baseline and Week 6 | Cognitive flexibility and executive control will be assessed using the Stroop Color-Word Test (TBAG form). The interference score (difference in reaction time between incongruent and color conditions) will be used as the main outcome. Unit of Measure: milliseconds (ms) |
| Secondary | Change in Alpha Diversity Assessed by Shannon Index | Baseline and Week 6 | lpha diversity of oral microbiota will be assessed using the Shannon Index, based on 16S rRNA gene sequencing. Unit of Measure: Shannon diversity index (unitless) |
| Secondary | Change in Beta Diversity Assessed by UniFrac and Bray-Curtis Distances | Baseline and Week 6 | Beta diversity of oral microbiota will be assessed using UniFrac and Bray-Curtis distances, based on 16S rRNA gene sequencing. Unit of Measure: Distance metric (unitless) |
| Secondary | Change in Salivary Flow Rate | Baseline and Week 6 | Unstimulated whole saliva will be collected for 5 minutes. Flow rate will be calculated and expressed in mL/min. Differences from baseline to week 6 will be analyzed. |
| Secondary | Change in Salivary pH | Baseline and Week 6 | Salivary pH will be measured from unstimulated whole saliva samples collected over 5 minutes. Differences from baseline to week 6 will be analyzed.Unit of Measure: pH value (unitless) |
| Secondary | Change in Salivary Total Antioxidant Capacity (FRAP Method) | Baseline and Week 6 | The Ferric Reducing Antioxidant Power (FRAP) assay will be used to evaluate the total antioxidant capacity of unstimulated saliva samples. Results will be expressed as micromoles of Fe²⁺ equivalents per milliliter (µmol Fe²⁺/mL). |
| Secondary | Change in Salivary Total Phenolic Content (Folin-Ciocalteu Method) | Baseline and Week 6 | The Folin-Ciocalteu colorimetric method will be used to quantify the total phenolic content in unstimulated saliva. Results will be reported as milligrams of gallic acid equivalents per milliliter (mg GAE/mL). |
| Secondary | Change in Salivary Streptococcus mutans Count | Baseline and Week 6 | Salivary concentration of Streptococcus mutans will be assessed using microbiological culturing on selective agar. Results will be reported as colony-forming units per milliliter (CFU/mL). |
| Secondary | Change in Salivary Lactobacillus spp. Count | Baseline and Week 6 | Salivary concentration of Lactobacillus spp. will be assessed using microbiological culturing on selective agar. Results will be reported as colony-forming units per milliliter (CFU/mL). |
| Secondary | Product Acceptability Score (Hedonic Scale) | Initial Exposure and Week 6 | Participants will evaluate the taste, texture, aroma, and overall liking of the chewing gum using a 9-point hedonic scale (1 = Dislike extremely, 9 = Like extremely). Higher scores indicate greater acceptability. Unit of Measure: Score (1-9) |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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