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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
150
Toothpaste containing a gum-heath active and fluoride
Toothpaste containing fluoride
Faculty of Dentistry, University of Indonesia
Jakarta Pusat, Indonesia
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.
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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