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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test toothpaste group | Experimental | Test Toothpaste |
|
| Negative control group | Active Comparator | Negative control toothpaste |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test Toothpaste | Other | Toothpaste containing a gum-heath active and fluoride |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Baseline, Week 17 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Associate Prof. Benso Sulijaya | Contact | (+6221) 3911502 | bensosulijaya@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, University of Indonesia | Recruiting | Jakarta Pusat | 10430 | Indonesia |
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| ID | Term |
|---|---|
| D005891 | Gingivitis |
| D005884 | Gingival Hemorrhage |
| D003773 | Dental Plaque |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
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| Control Toothpaste |
| Other |
Toothpaste containing fluoride |
|
| 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. | 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. | Baseline, Week 4, Week 13 |
| 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. | Baseline, Week 4, Week 13 and Week 17 |
| D009057 |
| Stomatognathic Diseases |
| D006472 | Oral Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003741 | Dental Deposits |
| D014076 | Tooth Diseases |