A Phase 3 interventional study of Active Oral Hygiene Regimen and Placebo Oral Hygiene Regimen in Periodontal Disease and Gingival Inflammation and Bleeding, sponsored by Colgate Palmolive. Not yet recruiting at 2 sites in Brazil. Open to participants aged 30 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by Colgate Palmolive · Phase 3, Interventional, and Treatment
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.
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.
867 studies on the registry are indexed under Periodontal Diseases; 189 are open to participants now.
This study's planned enrollment of 100 is above the median of 45 across 557 interventional studies indexed under Periodontal Diseases.
Browse Periodontal Diseases studies →Colgate Palmolive is the lead sponsor of 119 studies on the registry; 13 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 2 (6%) have results posted.
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Exclusion Criteria:
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.
Combination Product: Active Oral Hygiene Regimen
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.
Combination Product: Placebo Oral Hygiene Regimen
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.
Participants use a fluoride placebo mouthwash, standard fluoride toothpaste, soft bristle toothbrush, and dental floss for the duration of the study.
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.
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months post-treatment
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
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)
GCF collected via sterile paper strips and analyzed for host biomarkers using enzyme-linked immunosorbent assay (ELISA) techniques
Time frame: Baseline, 3 weeks, 3 months, 6 months, 9 months, and 12 months post-treatment
Plan to share: No
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Start is estimated for Sep 2026; primary completion for Mar 2028, 18 months later.
Of 19 phase 3 interventional studies under Periodontal Diseases, half reached primary completion within 6 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 23. This study's planned 18 months is above that.
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This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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