Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 2:15 AM
Study NCT ID:
NCT07415733
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-17
First Post:
2026-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of a Toothpaste Containing a Gum Health Active in Participants With Gingival Problem
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005891', 'term': 'Gingivitis'}, {'id': 'D005884', 'term': 'Gingival Hemorrhage'}, {'id': 'D003773', 'term': 'Dental Plaque'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D005882', 'term': 'Gingival Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D006472', 'term': 'Oral Hemorrhage'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003741', 'term': 'Dental Deposits'}, {'id': 'D014076', 'term': 'Tooth Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-09', 'studyFirstSubmitDate': '2026-02-02', 'studyFirstSubmitQcDate': '2026-02-09', 'lastUpdatePostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in oral health biomarkers and biological responses', 'timeFrame': 'Baseline, Week 4, Week 13 and Week 17', 'description': '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.'}, {'measure': 'Change in oral health-related quality of life as measured by the Oral Health Impact Profile applied to Periodontal Disease (OHIP-14-PD) questionnaire', 'timeFrame': 'Baseline, Week 4, Week 13 and Week 17', 'description': '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.\n\n\\[4\\] Rodríguez Franco NI, Moral de la Rubia J. The Open Dentistry Journal 2018, 12:1152-1161.'}], 'primaryOutcomes': [{'measure': 'Change in gingival condition as measured by Gingival Index', 'timeFrame': 'Baseline, Week 17', 'description': '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.\n\n\\[1\\] LOE H, SILNESS J. Acta Odontol Scand. 1963;21:533-551.'}, {'measure': 'Change in plaque level as measured by Full Mouth Plaque Score', 'timeFrame': 'Baseline, Week 17', 'description': "Plaque will be scored using a dichotomous index (presence or absence of plaque). The Full Mouth Plaque Score (FMPS, %) will be calculated as:\n\n(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.\n\n\\[2\\] D'Elia G, Floris W, Marini L, et al. Dent J (Basel). 2023 Jul 17;11(7):172."}, {'measure': 'Change in gingival bleeding measured by Bleeding on Probing', 'timeFrame': 'Baseline, Week 17', 'description': '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).\n\n\\[3\\] Joss A, Adler R, Lang NP. J Clin Periodontol. 1994;21(6):402-408.'}], 'secondaryOutcomes': [{'measure': 'Change in gingival condition as measured by Gingival Index', 'timeFrame': 'Baseline, Week 4, Week 13', 'description': '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.\n\n\\[1\\] LOE H, SILNESS J. Acta Odontol Scand. 1963;21:533-551.'}, {'measure': 'Change in plaque level as measured by Full Mouth Plaque Score', 'timeFrame': 'Baseline, Week 4, Week 13', 'description': "Plaque will be scored using a dichotomous index (presence or absence of plaque). The Full Mouth Plaque Score (FMPS, %) will be calculated as:\n\n(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.\n\n\\[2\\] D'Elia G, Floris W, Marini L, et al. Dent J (Basel). 2023 Jul 17;11(7):172."}, {'measure': 'Change in gingival bleeding measured by Bleeding on Probing', 'timeFrame': 'Baseline, Week 4, Week 13', 'description': '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).\n\n\\[3\\] Joss A, Adler R, Lang NP. J Clin Periodontol. 1994;21(6):402-408.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gingival Inflammation', 'Gingival Bleeding', 'Dental Plaque']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n* Participants must be able to read and understand study instructions and any other relevant study documents.\n* Have at least 20 natural teeth without subgingival calculus, including 5 assessable teeth (excluding 3rd molars) in each quadrant.\n* Have a mean whole mouth BOP ≥ 10% at screening.\n* Willing to follow the lifestyle and dietary restrictions as detailed in the Information Sheet for study.\n\nExclusion Criteria:\n\n* Be pregnant or breastfeeding.\n* Participants who participated in gum health study within 3 months prior to screening.\n* Current participation in any other cosmetic studies, any dental clinical studies or clinical trials.\n* Participants who have used any gum health products in the 4 weeks prior to screening.\n* 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.\n* Have more than three sites with a probing pocket depth (PPD) of ≥ 5 mm.\n* Full or partial dentures wearers.\n* Current orthodontic treatment.\n* Smokers or those who have a recent smoking history, including e-cigarettes.\n* Diabetics.\n* Have had a dental prophylaxis in the month prior to enrolment or have one scheduled prior to the end of the study.\n* 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.\n* Taking dietary supplements (e.g. multivitamins, antioxidants, fish oils, etc.).\n* Known allergy to any ingredient in study products.\n* The participant is a Unilever employee or a member of the study team.\n* Any participant who, in the judgement of the investigator, should not participate in the study.'}, 'identificationModule': {'nctId': 'NCT07415733', 'briefTitle': 'Evaluation of a Toothpaste Containing a Gum Health Active in Participants With Gingival Problem', 'organization': {'class': 'INDUSTRY', 'fullName': 'Unilever R&D'}, 'officialTitle': 'A Randomized Clinical Study on the Effect of a Toothpaste Containing a Gum Health Active in Participants With Gingival Problem', 'orgStudyIdInfo': {'id': 'ORL-GUM-4154'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test toothpaste group', 'description': 'Test Toothpaste', 'interventionNames': ['Other: Test Toothpaste']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Negative control group', 'description': 'Negative control toothpaste', 'interventionNames': ['Other: Control Toothpaste']}], 'interventions': [{'name': 'Test Toothpaste', 'type': 'OTHER', 'description': 'Toothpaste containing a gum-heath active and fluoride', 'armGroupLabels': ['Test toothpaste group']}, {'name': 'Control Toothpaste', 'type': 'OTHER', 'description': 'Toothpaste containing fluoride', 'armGroupLabels': ['Negative control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10430', 'city': 'Jakarta Pusat', 'country': 'Indonesia', 'facility': 'Faculty of Dentistry, University of Indonesia', 'geoPoint': {'lat': -6.1818, 'lon': 106.8223}}], 'centralContacts': [{'name': 'Associate Prof. Benso Sulijaya', 'role': 'CONTACT', 'email': 'bensosulijaya@gmail.com', 'phone': '(+6221) 3911502'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Unilever R&D', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}