Evaluation of a Toothpaste Containing a Gum Health Active in Participants With Gingival Problem

Official title

A Randomized Clinical Study on the Effect of a Toothpaste Containing a Gum Health Active in Participants With Gingival Problem

Overview

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

• Other Test Toothpaste
  Toothpaste containing a gum-heath active and fluoride
• Other Control Toothpaste
  Toothpaste containing fluoride

Primary outcome measures

• Change in gingival condition as measured by Gingival Index [Time frame: Baseline, Week 17]
• Change in plaque level as measured by Full Mouth Plaque Score [Time frame: Baseline, Week 17]
• Change in gingival bleeding measured by Bleeding on Probing [Time frame: Baseline, Week 17]

Secondary outcome measures (3)

• Change in gingival condition as measured by Gingival Index [Time frame: Baseline, Week 4, Week 13]
• Change in plaque level as measured by Full Mouth Plaque Score [Time frame: Baseline, Week 4, Week 13]
• Change in gingival bleeding measured by Bleeding on Probing [Time frame: Baseline, Week 4, Week 13]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Prevention

Study locations

Indonesia · 1 center

• Faculty of Dentistry, University of Indonesia — Jakarta Pusat

Identifiers

NCT: NCT07415733 · ORL-GUM-4154

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗