An interventional study of Test Toothpaste and Control Toothpaste in Gingival Inflammation, Gingival Bleeding and Dental Plaque, sponsored by Unilever R&D. Active, not recruiting at 1 site in Indonesia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Unilever R&D (part of Unilever) · Not applicable, Interventional, and Prevention
The primary objective of this clinical study is to evaluate the impact on gingival health when participants switch to a fluoride toothpaste without gum-health actives for 4 weeks after using a proven gum-health toothpaste for 13 weeks.
This is a double-blind, randomized, controlled, parallel design study. A minimum of 150 participants (75 per group) will be enrolled according to the inclusion and exclusion criteria. The accepted participants will be randomly allocated to one of the two test products, which they will use at home twice daily for 13 weeks, followed by a switch to use a fluoride toothpaste without gum-health actives (the same formulation as the negative control) for an additional 4 weeks. Dental assessments of gingival condition, plaque levels and gingival bleeding will be performed at baseline, Weeks 4, 13 and 17. Gingival crevicular fluid (GCF) samples will be taken to detect biomarkers, and supragingival plaque samples will be collected to evaluate changes in microbial species relevant to gingival health. The Oral Health Impact Profile applied to Periodontal Disease (OHIP-14-PD) questionnaire will also be administered.
631 studies on the registry are indexed under Gingivitis; 107 are open to participants now.
This study's planned enrollment of 150 is above the median of 66 across 507 interventional studies indexed under Gingivitis.
Browse Gingivitis studies →Unilever R&D is the lead sponsor of 71 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Test Toothpaste
Other: Test Toothpaste
Negative control toothpaste
Other: Control Toothpaste
Toothpaste containing a gum-heath active and fluoride
Toothpaste containing fluoride
Change in gingival condition as measured by Gingival Index
The gingival condition will be assessed using gingival index (GI) \[1\]. The scoring criteria are: 0 = Absence of inflammation; 1 = Mild inflammation - slight change in colour and little change in texture; 2 = Moderate inflammation - moderate glazing, redness,oedema, and hypertrophy, bleeding on pressure; 3 = Severe inflammation - marked redness and hypertrophy, tendency to spontaneous bleeding, ulceration. Six sites on each tooth will be assessed, three on facial (buccal, mesial and distal) and three on palatal/lingual (palatal/lingual, mesial and distal) surfaces. \[1\] LOE H, SILNESS J. Acta Odontol Scand. 1963;21:533-551.
Time frame: Baseline, Week 17
Change in plaque level as measured by Full Mouth Plaque Score
Plaque will be scored using a dichotomous index (presence or absence of plaque). The Full Mouth Plaque Score (FMPS, %) will be calculated as: (Number of sites with plaque/Total number of sites assessed) × 100 \[2\]. Six sites per tooth will be assessed, three on facial (buccal, mesial and distal) and three on palatal/lingual (palatal/lingual, mesial and distal) surfaces. \[2\] D'Elia G, Floris W, Marini L, et al. Dent J (Basel). 2023 Jul 17;11(7):172.
Time frame: Baseline, Week 17
Change in gingival bleeding measured by Bleeding on Probing
Bleeding on Probing (BOP) is defined as the percentage of sites that bleed upon probing \[3\]. Six sites per tooth will be assessed: three on the facial surface (buccal, mesial, distal) and three on the palatal/lingual surface (palatal/lingual, mesial, distal). \[3\] Joss A, Adler R, Lang NP. J Clin Periodontol. 1994;21(6):402-408.
Time frame: Baseline, Week 17
Change in gingival condition as measured by Gingival Index
The gingival condition will be assessed using gingival index (GI) \[1\]. The scoring criteria are: 0 = Absence of inflammation; 1 = Mild inflammation - slight change in colour and little change in texture; 2 = Moderate inflammation - moderate glazing, redness,oedema, and hypertrophy, bleeding on pressure; 3 = Severe inflammation - marked redness and hypertrophy, tendency to spontaneous bleeding, ulceration. Six sites per tooth will be assessed, three on facial (buccal, mesial and distal) and three on palatal/lingual (palatal/lingual, mesial and distal) surfaces. \[1\] LOE H, SILNESS J. Acta Odontol Scand. 1963;21:533-551.
Time frame: Baseline, Week 4, Week 13
Change in plaque level as measured by Full Mouth Plaque Score
Plaque will be scored using a dichotomous index (presence or absence of plaque). The Full Mouth Plaque Score (FMPS, %) will be calculated as: (Number of sites with plaque/Total number of sites assessed) × 100 \[2\]. Six sites per tooth will be assessed, three on facial (buccal, mesial and distal) and three on palatal/lingual (palatal/lingual, mesial and distal) surfaces. \[2\] D'Elia G, Floris W, Marini L, et al. Dent J (Basel). 2023 Jul 17;11(7):172.
Time frame: Baseline, Week 4, Week 13
Change in gingival bleeding measured by Bleeding on Probing
Bleeding on Probing (BOP) is defined as the percentage of sites that bleed upon probing \[3\]. Six sites per tooth will be assessed: three on the facial surface (buccal, mesial, distal) and three on the palatal/lingual surface (palatal/lingual, mesial, distal). \[3\] Joss A, Adler R, Lang NP. J Clin Periodontol. 1994;21(6):402-408.
Time frame: Baseline, Week 4, Week 13
Change in oral health biomarkers and biological responses
Gingival crevicular fluid (GCF) samples will be collected from a tooth site with gingival inflammation for each participant. Biomarkers will be analyzed from GCF samples using ELISA. Supragingival plaque will be collected from the same tooth site selected for GCF sampling. The microbiological status, based on the expression of bacteria will be analyzed from plaque sample through RT-PCR.
Time frame: Baseline, Week 4, Week 13 and Week 17
Change in oral health-related quality of life as measured by the Oral Health Impact Profile applied to Periodontal Disease (OHIP-14-PD) questionnaire
Quality of life will be evaluated using Oral Health Impact Profile Scale applied to Periodontal Disease (OHIP-14-PD) questionnaire \[4\]. The instrument consists of 14 questions covering seven dimensions: functional limitation, physical discomfort, psychological discomfort, physical disability, psychological disability, social disability and handicap. \[4\] Rodríguez Franco NI, Moral de la Rubia J. The Open Dentistry Journal 2018, 12:1152-1161.
Time frame: Baseline, Week 4, Week 13 and Week 17
Plan to share: No
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Started Feb 2026 (actual). Primary completion is estimated for Nov 2026, 9 months after the start.
Of 53 industry-sponsored interventional studies with no phase under Gingivitis, half reached primary completion within 3 months of starting (the median), counting those still running; a quarter within 1 and three quarters within 5. This study's planned 9 months is above that.
Counting every sponsor, half of 257 studies reached it within 7 months; a quarter within 3 and three quarters within 15.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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