Evaluation of a Toothpaste Containing a Gum Health Active in Participants With Gingival Problem
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUnilever R&D
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Participants need to be competent i.e., able to understand what is to take place and able to provide a free decision on agreeing to the activity/taking part in the study on this.
Participants must be able to read and understand study instructions and any other relevant study documents.
Have at least 20 natural teeth without subgingival calculus, including 5 assessable teeth (excluding 3rd molars) in each quadrant.
Have a mean whole mouth BOP ≥ 10% at screening.
Disqualifiers
Be pregnant or breastfeeding.
Participants who participated in gum health study within 3 months prior to screening.
Current participation in any other cosmetic studies, any dental clinical studies or clinical trials.
Participants who have used any gum health products in the 4 weeks prior to screening.
Trial design
Design model
Parallel
Treatments tested in this trial
Test Toothpaste
Other interventionToothpaste containing a gum-heath active and fluoride
Control Toothpaste
Other interventionToothpaste containing fluoride
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Test toothpaste groupExperimental treatment 1 intervention
Group B: Negative control groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 172
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 173
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 17Secondary outcomes
1
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 132
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 133
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 13Other outcomes
1
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 172
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 17Sponsors and contacts
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Source ClinicalTrials.gov