Periodontal DiseasePhase 3PEREGNCT07803484
Efficacy of Oral Hygiene Regimens in Patients Undergoing Non-Surgical Periodontal Treatment
A Phase 3 study testing Active Oral Hygiene Regimen in people with Periodontal Disease and Gingival Inflammation and Bleeding, run by Colgate Palmolive at 2 sites in Brazil.
Trial summary
The objective of this clinical study is to evaluate the efficacy of multi-component oral hygiene regimens as adjunctive to non-surgical periodontal treatment in patients with stage II periodontitis. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Periodontal Disease, Gingival Inflammation and Bleeding
- What is being tested?
- Active Oral Hygiene Regimen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesBrazil
- Study dates
- 1 Sep 2026to 30 Apr 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females, between 30-70 years of age, inclusive.
- Good general health. Minimum of 15 uncrowned permanent natural teeth (excluding third molars and crowns).
- Clinical diagnosis of stage II generalized periodontitis.
Who cannot join
- Periodontal treatment undergone 3 months before the beginning of the study. - Mucosal oral pathology.
- Uncontrolled systemic chronic disease that may interfere with host response. - Use of anti-inflammatory and antibiotic within 3 months prior to the start of the study, scheduled to start such intake during the treatment phase, or use of therapeutic mouthwash within the last three months.
- Need for antibiotic prophylaxis.
- Participation in any other clinical study.
- Pregnant, breastfeeding, or intended to get pregnant during the study.
- Allergic to oral care products, personal care consumer products, or their ingredients.
- Ongoing use of medications known to affect the gingival tissues (e.g., calcium channel blockers, phenytoin, cyclosporine).
- Current smokers and subjects with a history of alcohol or drug abuse. - Orthodontic appliances or presence of fixed or removable prosthodontics dentures that may interfere with the evaluations.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil2 sites
Federal University of Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90035-003
Cassiano K Rosing, PhD, +55 51 99511 9123, ckrosing@hotmail.com
University of São Paulo, School of Dentistry
São Paulo, São Paulo, 90035-003
Cristina C Villar, PhD, +55 11 26488055, villar@usp.br
About this study
Official title: Efficacy of Multi-component Oral Hygiene Regimens in Patients Undergoing Non-surgical Periodontal Treatment: a Multicentered Randomized Clinical Trial.
The objective of this clinical study is to evaluate the efficacy of multi-component oral hygiene regimens as adjunctive to non-surgical periodontal treatment in patients with stage II periodontitis.
Read the detailed description
This is a Phase III, multicenter, controlled, randomized, double-blind clinical trial with two parallel arms. A total of 100 participants, aged 30 to 70, diagnosed with stage II generalized periodontitis will undergo non-surgical periodontal treatment and be randomized to one of two at-home oral hygiene regimens. Participants will be monitored over a 12-month period to assess clinical periodontal parameters.
- Being tested
- Active Oral Hygiene Regimen, Placebo Oral Hygiene Regimen
- Keywords
- Periodontitis, Oral hygiene, Non-surgical periodontal treatment, Mouthwashes, Toothpastes
- Medical subject headings
- Periodontal Diseases, Gingivitis, Hemorrhage, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Oral Hygiene RegimenCombination product
Participants use a 0.12% chlorhexidine mouthwash and stannous fluoride toothpaste for 3 weeks (Regimen I). Afterwards, they switch to a 0.09% CPC and 0.28% Zinc Lactate mouthwash with fluoride and stannous fluoride toothpaste (Regimen II). Both regimens include a soft bristle toothbrush and dental floss.
Placebo Oral Hygiene RegimenCombination product
Participants use a fluoride placebo mouthwash, standard fluoride toothpaste, soft bristle toothbrush, and dental floss for the duration of the study.
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | Participants receive non-surgical periodontal treatment followed by an adjunctive oral hygiene regimen (Regimen I) consisting of a chlorhexidine mouthwash, stannous fluoride toothpaste, toothbrush, and floss for 3 weeks. Afterward, they switch to Regimen II consisting of a CPC/Zinc Lactate mouthwash, stannous fluoride toothpaste, toothbrush, and floss. Receives: Combination Product: Active Oral Hygiene Regimen |
| Negative Control Group | Placebo comparator | Participants receive non-surgical periodontal treatment followed by an adjunctive oral hygiene regimen consisting of a fluoride placebo mouthwash, standard fluoride toothpaste, toothbrush, and floss for the duration of the study. Receives: Combination Product: Placebo Oral Hygiene Regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pocket depth (PD) reduction
The distance measured between the gingival margin and the bottom of the gingival sulcus or the periodontal pocket, assessed at six sites per tooth using a calibrated periodontal probe.
Measured: Baseline, 3 months, 6 months, 9 months, and 12 months post-treatment
Secondary outcomes (7)
Change in Gingival Index (GI)
Evaluated using the Löe-Silness Gingival Index (score 0-3) on all scorable surfaces to determine a whole mouth mean score representing gingival inflammation and bleeding.
Measured: Baseline, 3 weeks, 3 months, 6 months, 9 months, and 12 months post-treatment
Change in Plaque Index (PI)
Evaluated using the Löe \& Silness Plaque Index (score 0-3) on all scorable surfaces to determine a whole mouth mean score representing microbial plaque accumulation.
Measured: Baseline, 3 weeks, 3 months, 6 months, 9 months, and 12 months post-treatment
Clinical Attachment Level (CAL) gain
The distance measured between the cemento-enamel junction and the bottom of the gingival sulcus or periodontal pocket, assessed at six sites per tooth.
Measured: Baseline, 3 months, 6 months, 9 months, and 12 months post-treatment
Change in Bleeding on Probing (BOP)
Evaluated using the Ainamo \& Bay Index, scoring the presence or absence of bleeding in the gingival sulcus after gentle probing, expressed as a percentage of bleeding sites over total sites.
Measured: Baseline, 3 months, 6 months, 9 months, and 12 months post-treatment
Number of residual pockets
The quantity of sites exhibiting residual pockets (PD >= 4 mm with bleeding on probing).
Measured: 3 months, 6 months, 9 months, and 12 months post-treatment
Change in subgingival microbiological composition
Subgingival plaque collected via sterile curette and analyzed by qPCR to determine total and relative bacterial quantification.
Measured: Baseline, 3 weeks, 3 months, 6 months, 9 months, and 12 months post-treatment
Change in levels of immunological mediators in gingival crevicular fluid (GCF)
GCF collected via sterile paper strips and analyzed for host biomarkers using enzyme-linked immunosorbent assay (ELISA) techniques
Measured: Baseline, 3 weeks, 3 months, 6 months, 9 months, and 12 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Mar 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseaseStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Colgate Palmolive
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07803484
- Sponsor's protocol ID
- CRO-2025-04-PERIO-RG-BZ-CB
- Acronym
- PEREG
- Status last verified
- Aug 2026
- First submitted
- 31 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Multi-component Oral Hygiene Regimens in Patients Undergoing Non-surgical Periodontal Treatment: a Multicentered Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT07803484
- Acronym / sponsor ID
- PEREG / CRO-2025-04-PERIO-RG-BZ-CB
- Keywords
- Periodontitis, Oral hygiene, Non-surgical periodontal treatment, Mouthwashes, Toothpastes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Colgate PalmoliveIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Mar 2028 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 3 Sep 2026 (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 clinical study is to evaluate the efficacy of multi-component oral hygiene regimens as adjunctive to non-surgical periodontal treatment in patients with stage II periodontitis.
Detailed description
This is a Phase III, multicenter, controlled, randomized, double-blind clinical trial with two parallel arms. A total of 100 participants, aged 30 to 70, diagnosed with stage II generalized periodontitis will undergo non-surgical periodontal treatment and be randomized to one of two at-home oral hygiene regimens. Participants will be monitored over a 12-month period to assess clinical periodontal parameters.
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 Group | Experimental | Combination Product: Active Oral Hygiene RegimenParticipants receive non-surgical periodontal treatment followed by an adjunctive oral hygiene regimen (Regimen I) consisting of a chlorhexidine mouthwash, stannous fluoride toothpaste, toothbrush, and floss for 3 weeks. Afterward, they switch to Regimen II consisting of a CPC/Zinc Lactate mouthwash, stannous fluoride toothpaste, toothbrush, and floss. |
| Negative Control Group | Placebo comparator | Combination Product: Placebo Oral Hygiene RegimenParticipants receive non-surgical periodontal treatment followed by an adjunctive oral hygiene regimen consisting of a fluoride placebo mouthwash, standard fluoride toothpaste, toothbrush, and floss for the duration of the study. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males and females, between 30-70 years of age, inclusive.
- Good general health. Minimum of 15 uncrowned permanent natural teeth (excluding third molars and crowns).
- Clinical diagnosis of stage II generalized periodontitis.
Key exclusion criteria (8 listed)
- Periodontal treatment undergone 3 months before the beginning of the study. - Mucosal oral pathology.
- Uncontrolled systemic chronic disease that may interfere with host response. - Use of anti-inflammatory and antibiotic within 3 months prior to the start of the study, scheduled to start such intake during the treatment phase, or use of therapeutic mouthwash within the last three months.
- Need for antibiotic prophylaxis.
- Participation in any other clinical study.
- Pregnant, breastfeeding, or intended to get pregnant during the study.
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 |
|---|---|---|
| Active Oral Hygiene RegimenParticipants use a 0.12% chlorhexidine mouthwash and stannous fluoride toothpaste for 3 weeks (Regimen I). Afterwards, they switch to a 0.09% CPC and 0.28% Zinc Lactate mouthwash with fluoride and stannous fluoride toothpaste (Regimen II). Both regimens include a soft bristle toothbrush and dental floss. | Combination product | Test Group |
| Placebo Oral Hygiene RegimenParticipants use a fluoride placebo mouthwash, standard fluoride toothpaste, soft bristle toothbrush, and dental floss for the duration of the study. | Combination product | Negative Control Group |
Primary outcome
Pocket depth (PD) reduction
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months post-treatment
The distance measured between the gingival margin and the bottom of the gingival sulcus or the periodontal pocket, assessed at six sites per tooth using a calibrated periodontal probe.
7 secondary outcomes
Change in Gingival Index (GI)
Time frame: Baseline, 3 weeks, 3 months, 6 months, 9 months, and 12 months post-treatment
Change in Plaque Index (PI)
Time frame: Baseline, 3 weeks, 3 months, 6 months, 9 months, and 12 months post-treatment
Clinical Attachment Level (CAL) gain
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months post-treatment
Change in Bleeding on Probing (BOP)
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months post-treatment
Number of residual pockets
Time frame: 3 months, 6 months, 9 months, and 12 months post-treatment
Change in subgingival microbiological composition
Time frame: Baseline, 3 weeks, 3 months, 6 months, 9 months, and 12 months post-treatment
Change in levels of immunological mediators in gingival crevicular fluid (GCF)
Time frame: Baseline, 3 weeks, 3 months, 6 months, 9 months, and 12 months post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Active Oral Hygiene Regimen in people with Periodontal Disease and Gingival Inflammation and Bleeding, run by Colgate Palmolive at 2 sites in Brazil.
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 3 inclusion and 8 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: opening soon, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cristina C Villar, PhD (+55 11 26488055, villar@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pocket depth (PD) reduction (time frame: Baseline, 3 months, 6 months, 9 months, and 12 months post-treatment). 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 3 Sep 2026.