Efficacy of a Toothpaste in Reducing Plaque, Gingivitis,... | NCT07499115

NCT07499115

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Test Toothpaste	Experimental	Daily toothbrushing, Twice daily, 2 minutes each time	Drug: Toothpaste containing chitosan
Control Toothpaste	Active Comparator	Daily toothbrushing, Twice daily, 2 minutes each time	Drug: Colgate Cavity Protection Toothpaste

Name	Type	Description	Arm Group Labels	Other Names
Toothpaste containing chitosan	Drug	Toothpaste containing chitosan and a commercially available soft-bristled toothbrush	Test Toothpaste

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Modified Gingival Index (MGI_ Lobene)	Clinical assessments will be carried out using the Modified Gingival Index (MGI; Lobene et al., 1986).MGI scoring criteria: 0: Absence of inflammation Mild inflammation; slight change in color, little change in texture of any portion of, but not the entire, marginal or papillary gingival unit Mild inflammation; as above, but involving the entire marginal or papillary gingival unit Moderate inflammation; glazing, redness, edema, and/or hypertrophy of the marginal or papillary gingival unit Severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration	Baseline, 2 week, 1 month & 3 month
Modified Plaque Index (MPI_ Turesky)	Using a red disclosing solution, a Modified Plaque Index (Turesky et al, 1970) score of 0-5 will be assigned to all scorable disclosed surfaces of the maxillary and mandibular teeth using a dental light and dental mirror. A whole-mouth score will be determined by summing the values for all scorable surfaces and dividing by the total number of surfaces scored. Modified Plaque Index (Turesky) scoring criteria: 0: No plaque Separate flecks of plaque at the cervical margin A thin, continuous band of plaque (up to 1 mm) at the cervical margin A band of plaque wider than 1 mm but covering less than one-third of the crown Plaque covering at least one-third but less than two-thirds of the crown Plaque covering two-thirds or more of the crown	Baseline, 2 week, 1 month & 3 month
Gingival Bleeding Index (GBI_ Saxton)	The examiner will conduct the Gingival Bleeding Index (GBI) examinations using the Saxton and van der Ouderaa methodology and a CPITN periodontal probe (0.5 mm ball end). Findings and GBI score calculations (including bleeding severity) will be recorded on the Gingival Bleeding Index Examination Form.	Baseline, 2 week, 1 month & 3 month

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female, aged 18-70 years (inclusive).
Available for the duration of the study.
Able to understand and willing to read and sign the Informed Consent Form after the nature of the study has been fully explained.
Willing to comply with all study procedures and clinical examination schedules.
Good general health (absence of any condition that, in the opinion of the study examiner, might pose risk during participation; e.g., certain heart conditions, valve/hip replacements).
Presence of at least 20 natural teeth (excluding third molars) with scorable facial and lingual surfaces.
Mean Modified Gingival Index (MGI, Lobene) ≥ 2.0 and Mean Modified Plaque Index (MPI, Turesky) ≥ 1.5 at screening.
Willing and able to complete study questionnaires on product usage experience during routine toothbrushing.

Exclusion Criteria:

Pregnant or lactating.
Use of tobacco products.
History of alcohol or drug abuse.
Any medical condition (e.g., significant heart or liver disease, bleeding disorders, blood dyscrasias) or current medication use that, in the investigator's judgment, may compromise subject safety or the quality of study results.
Medical condition requiring pre-medication prior to dental visits/procedures.
History of allergy to oral hygiene products.
Use of anti-inflammatory, immunosuppressive, antimicrobial, or anticoagulant drugs, or antibiotics within 30 days prior to study start or during the study.
Ongoing use of medications known to affect gingival tissues (e.g., calcium channel blockers, phenytoin, cyclosporine).
Presence of orthodontic bands or removable partial dentures.
Tumors of the soft or hard tissues of the oral cavity.
Five or more carious lesions requiring immediate restorative treatment.
More than two periodontal pockets (>4 mm) with bleeding on probing.
Any gingival condition (e.g., hyperplasia or overgrowth) that would interfere with clinical assessment.
Participation in another clinical study with an oral care indication or test panel within 30 days prior to study start.
Medical condition that prohibits abstaining from eating or drinking for up to 2 hours.

ID	Term
D003773	Dental Plaque
D005891	Gingivitis

ID	Term
D003741	Dental Deposits
D014076	Tooth Diseases
D009057	Stomatognathic Diseases
D007239	Infections