GingivitisPhase 3NCT07210138
Clinical Investigation of PerioGard (Test) Regimen
A Phase 3 study testing PeriGuard regimen and Colgate Dental Cream regimen in people with Gingivitis, run by Colgate Palmolive at 1 site in Thailand.
Trial summary
The objective of this three-month clinical research study is to evaluate the clinical efficacy of the PerioGard (test) regimen (0.45% SnF-HW Toothpaste, CPC-Zinc-Fluoride Mouthwash, Gummy Toothbrush) compared to the control regimen (regular fluoride toothpaste, fluoride mouthwash, flat-trim toothbrush) in reducing… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis
- What is being tested?
- PeriGuard regimen and Colgate Dental Cream regimen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteThailand
- Study dates
- 18 Aug 2025to 30 Dec 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects, ages 18-70, inclusive.
- Availability for the three-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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Clinical Investigation of PerioGard (Test) Regimen Compared to Control Regimen in Reducing Plaque and Gingivitis - a Three-month Study in Thailand
The objective of this three-month clinical research study is to evaluate the clinical efficacy of the PerioGard (test) regimen (0.45% SnF-HW Toothpaste, CPC-Zinc-Fluoride Mouthwash, Gummy Toothbrush) compared to the control regimen (regular fluoride toothpaste, fluoride mouthwash, flat-trim toothbrush) in reducing gingivitis and dental plaque in adults
- Conditions
- Gingivitis
- Being tested
- PeriGuard regimen, Colgate Dental Cream regimen
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PeriGuard regimenDrug
0.45% Stannous Fluoride Toothpaste, CPC-Zinc Fluoride Mouthwash, Gummy Toothbrush
Colgate Dental Cream regimenDrug
Colgate Cavity Protection Toothpaste, Fluoride Mouthwash,Colgate Extra Clean Soft-Bristled Toothbrush
| Study group | Role | What they receive |
|---|---|---|
| Test regimen | Experimental | Test Regimen: toothpaste, mouthwash and toothbrush Receives: Drug: PeriGuard regimen |
| Control regimen | Active comparator | Control regimen: toothpaste, mouthwash and toothbrush Receives: Drug: Colgate Dental Cream regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of Loe-Silness Gingival Index score
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. A whole mouth mean score for each subject will be determined by adding the values given by the examining dentist to each scoreable surface and dividing that number by the total number of surfaces scored.
Measured: baseline, 1 week, 4 week and 3 month
Measurement of Quigley-Hein Plaque Index score
First using a red dye solution to disclose the plaque, 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. A whole mouth score for each subject will be determined by adding the values given by the dental examiner to each scoreable surface and dividing that number by the total number of surfaces scored.
Measured: baseline, 1 week, 4 week and 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start18 Aug 2025
- Primary completion30 Dec 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies of the same condition, open and under way.
- More trials run by Colgate PalmoliveThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colgate Palmolive
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Terdphong Triratana, DDS, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07210138
- Sponsor's protocol ID
- CRO-2025-05-GUM-RGM-THA-YPZ
- Status last verified
- Jan 2026
- First submitted
- 29 Sep 2025
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Investigation of PerioGard (Test) Regimen Compared to Control Regimen in Reducing Plaque and Gingivitis - a Three-month Study in Thailand
- ClinicalTrials.gov ID
- NCT07210138
- Acronym / sponsor ID
- CRO-2025-05-GUM-RGM-THA-YPZ
- Conditions
- Gingivitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Colgate PalmoliveIndustry (pharma, biotech, devices)
- Study start
- 18 Aug 2025 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 7 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this three-month clinical research study is to evaluate the clinical efficacy of the PerioGard (test) regimen (0.45% SnF-HW Toothpaste, CPC-Zinc-Fluoride Mouthwash, Gummy Toothbrush) compared to the control regimen (regular fluoride toothpaste, fluoride mouthwash, flat-trim toothbrush) in reducing gingivitis and dental plaque in adults
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test regimen | Experimental | Drug: PeriGuard regimenTest Regimen: toothpaste, mouthwash and toothbrush |
| Control regimen | Active comparator | Drug: Colgate Dental Cream regimenControl regimen: toothpaste, mouthwash and toothbrush |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects, ages 18-70, inclusive.
- Availability for the three-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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PeriGuard regimen0.45% Stannous Fluoride Toothpaste, CPC-Zinc Fluoride Mouthwash, Gummy Toothbrush | Drug | Test regimen |
| Colgate Dental Cream regimenColgate Cavity Protection Toothpaste, Fluoride Mouthwash,Colgate Extra Clean Soft-Bristled Toothbrush | Drug | Control regimen |
Primary outcome
Measurement of Loe-Silness Gingival Index score
Time frame: baseline, 1 week, 4 week and 3 month
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. A whole mouth mean score for each subject will be determined by adding the values given by the examining dentist to each scoreable surface and dividing that number by the total number of surfaces scored.
Measurement of Quigley-Hein Plaque Index score
Time frame: baseline, 1 week, 4 week and 3 month
First using a red dye solution to disclose the plaque, 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. A whole mouth score for each subject will be determined by adding the values given by the dental examiner to each scoreable surface and dividing that number by the total number of surfaces scored.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Gingivitis
Enrolling by invitation
Comparison of the Effects of Oral Hygiene Regimens on Clinical, Immunomodulatory, and Microbial Outcomes and Oral Tolerance in People With Gingivitis
Microbiome, Cytokines
Active, not recruitingPhase 3
A Study to Assess the Efficacy of Two Brushing Regimens in the Reduction of Established Dental Plaque and Gingivitis
Plaque, Gingivitis
Not yet recruiting
Effectiveness of Personalized Digital Oral Health Intervention in Patients With Fixed Orthodontic Appliances.
Oral Hygiene in Patients With Fixed Orthodontic Appliances, Dental Plaque
Not yet recruitingPhase 2
Efficacy of Thymus Vulgaris Mouthwash in the Management of Biofilm-Induced Gingivitis
Plaque-Induced Gingivitis
Not yet recruitingPhase 3
Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
Preterm Birth, Low Birth Weight
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Terdphong Triratana, DDS principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PeriGuard regimen and Colgate Dental Cream regimen in people with Gingivitis, run by Colgate Palmolive at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of Loe-Silness Gingival Index score (time frame: baseline, 1 week, 4 week and 3 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.