Gingival Inflammation, Gingival Bleeding, Dental Plaque
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERTest Toothpaste
Toothpaste containing a gum-heath active and fluoride
OTHERControl Toothpaste
Toothpaste containing fluoride
Sponsors
Unilever R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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. * Willing to follow the lifestyle and dietary restrictions as detailed in the Information Sheet for study.
Exclusion criteria
* 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. * Obvious signs of untreated caries or significant periodontal disease, which in the opinion of the study dentist, will affect either the scientific validity of the study or if the participant to take part in the study would affect their wellbeing. * Have more than three sites with a probing pocket depth (PPD) of ≥ 5 mm. * Full or partial dentures wearers. * Current orthodontic treatment. * Smokers or those who have a recent smoking history, including e-cigarettes. * Diabetics. * Have had a dental prophylaxis in the month prior to enrolment or have one scheduled prior to the end of the study. * Medical condition and/or regular use of any medication which might affect the outcome of the study, as determined by the study dentist, principally a course of anti-inflammatory, antimicrobial or statin drugs within 4 weeks of screening. * Taking dietary supplements (e.g. multivitamins, antioxidants, fish oils, etc.). * Known allergy to any ingredient in study products. * The participant is a Unilever employee or a member of the study team. * Any participant who, in the judgement of the investigator, should not participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in gingival condition as measured by Gingival Index | Baseline, Week 17 | 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. |
| Change in plaque level as measured by Full Mouth Plaque Score | Baseline, Week 17 | 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. |
| Change in gingival bleeding measured by Bleeding on Probing | Baseline, Week 17 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in gingival condition as measured by Gingival Index | Baseline, Week 4, Week 13 | 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. |
| Change in plaque level as measured by Full Mouth Plaque Score | Baseline, Week 4, Week 13 | 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. |
| Change in gingival bleeding measured by Bleeding on Probing | Baseline, Week 4, Week 13 | 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. |
Countries
Indonesia
Contacts
CONTACTAssociate Prof. Benso Sulijaya
Outcome results
None listed