Clinical Study of Toothpaste Containing Zinc Lactate as Compared to Colgate Cavity Protection Toothpaste.

NCT06563518 — Phase 2, Completed, 92 participants, Colgate Palmolive

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The Clinical Investigation of Toothpaste Containing Zinc Lactate as Compared to Colgate Cavity Protection Toothpaste in Reducing Plaque and Gingivitis - a Six-month Study in Thailand

Registry	NCT06563518
Status	Completed
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	92 (Actual)
Sponsor	Colgate Palmolive (Industry)
Conditions	Gingivitis, Plaque
Interventions	Meridol, Colgate Cavity Protection (Drug)
Dates	start 2022-01-18, primary completion 2022-07-10, completion 2022-07-10, first posted 2024-08-21, last updated 2024-08-21
Locations	1 site in Thailand

-Summary

The objective of this six-month clinical research study is to evaluate the clinical efficacy of two dentifrices - Toothpaste containing zinc lactate and Colgate Cavity Protection Toothpaste in reducing gingivitis and dental plaque in adults.

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+Arms and interventions

Arm	Type	Interventions	Description
Group 1	Experimental	Drug: Meridol	Toothpaste
Group II	Active comparator	Drug: Colgate Cavity Protection	Toothpaste

Meridol (Drug): toothpaste
Colgate Cavity Protection (Drug): toothpaste

+Outcome measures

Primary outcomes

Gingivitis Assessment [baseline, 3 months and 6 months]: A Loe-Silness Gingival Index score from 0 to 3 will be assigned by the examining dentist to all scoreable surfaces of the maxillary and mandibular teeth using a dental light and dental mirror.
Plaque Assessment [baseline, 3 months and 6 months]: A Quigley-Hein Plaque Index score of 0 to 5 will be assigned to all scoreable disclosed surfaces of the maxillary and mandibular teeth using a dental light and dental mirror

+Eligibility

Sex: All, ages: 18 Years to 70 Years, accepts healthy volunteers

Inclusion Criteria:

* Subjects, ages 18-70, inclusive.
* Availability for the six-month duration of the clinical research study.
* Good general health.
* Minimum of 20 uncrowned permanent natural teeth (excluding third molars).
* Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index.
* Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification).
* Signed Informed Consent Form

Exclusion Criteria:

* Presence of orthodontic bands.
* Presence of partial removable dentures.
* Tumor(s) of the soft or hard tissues of the oral cavity.
* Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone).
* Five or more carious lesions requiring immediate restorative treatment.
* Antibiotic use any time during the one-month period prior to entry into the study.
* Participation in any other clinical study or test panel within the one month prior to entry into the study.
* Dental prophylaxis during the past two weeks prior to baseline examinations.
* History of allergies to oral care/personal care consumer products or their ingredients.
* On any prescription medicines that might interfere with the study outcome.
* An existing medical condition that prohibits eating or drinking for periods up to 4 hours.
* History of alcohol or drug abuse.
* Pregnant or lactating subjects.

+Locations (1)

Facility	City	Country	Status
Mahidol University	Ratchathewi, Bangkok	Thailand

+Publications

Results publication: Seriwatanachai D, Triratana T, Kraivaphan P, Huber N, Poth T, Mateo LR, Stellitano M, Zhang YP. Effectiveness of a novel amine + zinc + fluoride toothpaste in reducing plaque and gingivitis: results of a six-month randomized controlled trial. BMC Oral Health. 2025 Feb 5;25(1):188. doi: 10.1186/s12903-025-05551-z. PMID 39910536

+Investigators

Terdphong Triratana, Principal investigator, Managing Director of Dental Research Center