Dental Plaque, Gingivitis
Conditions
Brief summary
The aim of this study is to evaluate the efficacy of the test toothpaste compared to a regular fluoride toothpaste in the reducing gingivitis and plaque accumulation in Chinese participants with plaque-induced gingivitis.
Detailed description
This will be a single-center, 12-week, randomized, controlled, examiner-blind, two-group, stratified, parallel group design clinical study in participants with localized plaque-induced gingivitis. The study will investigate the ability of the test toothpaste to improve gingival health and plaque accumulation in participants with plaque induced gingivitis only. Sufficient participants will be screened to randomize approximately 120 participants to ensure approximately 108 participants (approximately 54 per group) complete the study.
Interventions
OTHERTest Toothpaste
A toothpaste containing Isopropyl Methyl Phenol (IPMP).
A regular sodium fluoride toothpaste containing 1450 parts per million (ppm).
Sponsors
HALEON
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed. * A participant who is willing and able to comply with scheduled visits, treatment plan, study restrictions, lifestyle considerations and other study procedures. * A participant in good general and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant or relevant abnormalities in medical history or upon oral examination, or condition, that would impact the participant's safety, wellbeing or the outcome of the study, if they were to participate in the study, or affect the individual's ability to understand and follow study procedures and requirements. * A participant with localized plaque-induced gingivitis, in the opinion of the clinical examiner or medically qualified designee, as confirmed by visual examination.
Exclusion criteria
* A participant who is an employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or a Haleon employee directly involved in the conduct of the study or a member of their immediate family. * A participant who has participated in other studies (including non-medicinal studies) involving study product(s) within 30 days prior to study entry and/or during study participation. * A participant with, in the opinion of the investigator (or medically qualified designee), an acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the participant inappropriate for entry into this study. * A participant who is pregnant (self-reported) or intending to become pregnant over the duration of the study. * A participant who is breastfeeding. * A participant with known or suspected intolerance or hypersensitivity to any study materials (or closely related compounds) or any of their stated ingredients. * A participant unwilling or unable to comply with lifestyle considerations described in this protocol. * Participants with, in the opinion of the investigator or medically qualified designee, any clinically significant/relevant abnormalities in medical history or oral examination, or any other condition, that would affect the individual's ability to understand and follow study procedures and requirements. * A participant with any medical condition which, in the opinion of the investigator or medically qualified designee, are causing xerostomia. * Participants with any medical condition which, in the opinion of the investigator or medically qualified designee, could directly influence gingival bleeding. * A participant who habitually rinses with water during toothbrushing (self-reported at Screening (Visit 1)). * Participants with recent history (within the last year) of alcohol or other substance abuse. * A participant who is a current smoker or an ex-smoker who stopped within 6 months of Screening (self-reported at Screening (Visit 1)). * A participant who currently uses smokeless forms of tobacco (example \[e.g.\], chewing tobacco, nicotine-based e-cigarettes). * A participant with oral mucosa disease (e.g., oral lichen planus, oral leukoplakia etc.) or a severe oral condition (e.g., acute necrotizing ulcerative gingivitis or oral or peri-oral ulceration including herpetic lesions) that, in the opinion of the investigator or dentally qualified designee, would compromise study outcomes or the oral health of the Participant /clinical examiner if they were to participate in the study. * A participant with a tongue or lip piercing, or any other oral feature that, in the opinion of the investigator or dentally qualified designee, could interfere with toothbrush usage or act as a plaque retentive factor. * A Participant who has previously been enrolled in this study. * A Participant who has used an anti-bacterial mouthwash (e.g., chlorhexidine) or use of any oral care product within 14 days of Baseline (Visit 2) that, in the opinion of the investigator or dentally qualified designee, could affect plaque formation or gingival health. * Periodontal Exclusions: 1. A participant with severe periodontitis or signs of active periodontitis who, in the opinion of the investigator or dentally qualified designee, should not participate in the study. 2. A participant with gingivitis which, in the opinion of the investigator or dentally qualified designee, would not be expected to respond to treatment with an anti-Gingivitis toothpaste. 3. A participant who is receiving or has received treatment for periodontal disease (including surgery) within 12 months of Screening. * Dental Exclusions: 1. A participant with active caries that, in the opinion of the investigator or dentally qualified designee, could compromise study outcomes or the oral health of the participant if they were to participate in the study. 2. A participant with a partial or full denture and with an orthodontic appliance (bands, appliances or fixed/ removable retainers). 3. A Participant who has received orthodontic therapy within 12 months of Screening. 4. A participant with numerous restorations in a poor state of repair. 5. A participant with any dental condition (e.g., overcrowding) that, in the opinion of the investigator or dentally qualified designee, could compromise study outcomes or the oral health of the participant if they were to participate in the study. 6. A participant who has had dental prophylaxis or teeth bleaching within 12 weeks of Screening. 7. A participant with high levels of extrinsic stain or calculus deposits that, in the opinion of the investigator or dentally qualified designee, could interfere with Baseline (preprophylaxis) plaque assessments. * A participant currently taking any such medication or oral care product which in opinion of the investigator could affect gingival condition * A participant who is not eligible for dental prophylaxis based on investigator or medically qualified designee review of their laboratory (blood) test results which includes blood platelet; white blood cell out of normal range; Prothrombin Time (PT) exceeds 15 seconds; Activated Partial Thromboplastin Time (APTT) exceeds 35 seconds; positive HIV test; positive HBV test, Hepatitis B Surface Antigen (HbsAg) and positive syphilis test. * A participant who, in the opinion of the investigator or medically qualified designee, should not participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Bleeding Index (Bl) at Week 12 | At Week 12 | Gingival bleeding will be assessed as an invasive assessment of BI. It will be assessed for all evaluable surfaces of the facial and lingual/palatal gingiva with six sites per tooth. To perform the bleeding assessment, a round-ended probe will be inserted approximately 1 millimeter (mm) into the gingival sulcus at approximately 60 degrees and will be moved from the distal interproximal area to the mesial interproximal area. Presence/ absence of gingival bleeding will be assessed for 30 seconds after probing and will be scored on a 3-points scale ranging from 0 to 2, where 0 equal to (=) no bleeding after 30 seconds; 1= bleeding observed within 30 seconds of probing; 2= bleeding observed immediately on probing. Lower score will indicate an improvement in the symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean BI At Week 2 and 6 | At Week 2 and 6 | Gingival bleeding will be assessed as an invasive assessment of BI. It will be assessed for all evaluable surfaces of the facial and lingual/palatal gingiva with six sites per tooth. To perform the bleeding assessment, a round-ended probe will be inserted approximately 1 mm into the gingival sulcus epithelium at approximately 60 degrees and will be moved from the distal interproximal area to the mesial interproximal area. Presence/ absence of gingival bleeding will be assessed for 30 seconds after probing and will be scored on a 3-points scale ranging from 0 to 2, where 0= no bleeding after 30 seconds; 1= bleeding observed within 30 seconds of probing; 2= bleeding observed an immediately on probing. Lower score will indicate an improvement in the symptoms. |
| Mean Number of Bleeding Site (NBS) At Week 2, 6 and 12 | At Week 2, 6 and 12 | Gingival bleeding will be assessed as an invasive assessment of BI. It will be assessed for all evaluable surfaces of the facial and lingual/palatal gingiva with six sites per tooth. To perform the bleeding assessment, a round-ended probe will be inserted approximately 1 mm into the gingival sulcus epithelium at approximately 60 degrees and will be moved from the distal interproximal area to the mesial interproximal area. The presence/ absence of gingival bleeding will be assessed for 30 seconds after probing. The NBS for each participant will be calculated as the number of evaluable tooth sites with bleeding observed immediately on probing or within 30 seconds of probing. |
| Mean Overall Turesky Modification of the Quigley Hein Index (TPI) At Week 2, 6 and 12 | At Week 2, 6 and 12 | TPI will be a non-invasive assessment of supra-gingival plaque accumulation. The plaque will first be disclosed using a plaque disclosing dye solution. The TPI will be assessed for all evaluable surfaces of the facial and lingual surfaces of each scoreable tooth. Three scores will be recorded facially and three lingually, generating six scores per tooth. The disclosed plaques will then be scored using a 6-point scale ranging from 0 to 5, where 0= No plaque; 1= Slight flecks of plaque at the cervical margin of the tooth; 2= Thin, continuous band of plaque 1 mm or smaller at the cervical margin of the tooth; 3= Band of plaque wider than 1 mm but covering less than 1/3 of the area; 4= Plaque covering at least 1/3 but less than 2/3 of the area; 5= Plaque covering 2/3 or more of the crown of the tooth. Lower score will indicate an improvement in the symptoms. |
| Mean Interproximal TPI At Week 2, 6 and 12 | At Week 2, 6 and 12 | TPI will be a non-invasive assessment of supra-gingival plaque accumulation. The plaque will first be disclosed using a plaque disclosing dye solution. The TPI will be assessed for all evaluable surfaces of the facial and lingual surfaces of each scoreable tooth. Three scores will be recorded facially and three lingually, generating six scores per tooth. The disclosed plaques will be scored using a 6-point scale ranging from 0 to 5, where 0= No plaque; 1= Slight flecks of plaque at the cervical margin of the tooth; 2= Thin, continuous band of plaque 1 mm or smaller at the cervical margin of the tooth; 3= Band of plaque wider than 1mm but covering less than 1/3 of the area; 4= Plaque covering at least 1/3 but less than 2/3 of the area; 5= Plaque covering 2/3 or more of the crown of the tooth. Lower score will indicate an improvement in the symptoms. |
| Mean Modified Gingival Index (MGI) At Week 2, 6 and 12 | At Week 2, 6 and 12 | The MGI is a non-invasive visual assessment of gingival health. It will be assessed for all evaluable teeth. For each tooth, scores will be recorded and will be scored on a 5-point scale ranging from 0 to 4, where 0= Absence of inflammation, 1= Mild inflammation; slight or little change in color; little change in texture of any portion of the marginal/ papillary gingival unit, 2= Mild inflammation; criteria as above, but involving the entire marginal/ papillary gingival unit, 3= Moderate inflammation; glazing, redness, edema, and/ or hypertrophy of the marginal/ papillary gingival unit, 4= Severe inflammation; marked redness, edema and/ or hypertrophy of the marginal/ papillary gingival unit, spontaneous bleeding, congestion, or ulceration. Lower score will indicate an improvement in the symptoms. |
Countries
China
Contacts
CONTACTHaleon Response Center
Outcome results
None listed