A comparative investigation to evaluate the clinical efficacy of an alcohol-free CPC-containing mouthwash as compared to a control mouthwash in controlling dental plaque and gingivitis: a six-month clinical study on adults in San Jose, Costa Rica.
Bibliographic record
Abstract
OBJECTIVE: This study was designed to evaluate the clinical efficacy of an antiplaque alcohol-free mouthwash containing 0.075% cetylpyridinium chloride (CPC) and 0.05% sodium fluoride (NaF), as compared to a control mouthwash containing only 0.05% NaF, in controlling established dental plaque and gingivitis after three and six months of product use. METHODS: This was a single-center, parallel-group, two-cell, double-blind, randomized clinical study. Prospective adult male and female subjects from San Jose, Costa Rica reported to the clinical facility having refrained from all oral hygiene procedures for 12 hours, and from eating, drinking, or smoking for four hours prior to their visit. Qualifying subjects who presented with Gingival Index scores (Löe and Silness Index) of at least 1.0 and Plaque Index scores (Turesky Modified Quigley-Hein Index) of at least 1.5 were allowed to participate in this study. Subjects were randomly assigned to one of two treatment groups according to their baseline gingival and plaque scores. In the first treatment group (Test), subjects used an alcohol-free mouthwash containing 0.075% CPC and 0.05% NaF, whereas in the second treatment group (Control), subjects used a mouthwash containing only 0.05% NaF. Gingivitis and plaque assessments, and examinations of oral hard and soft tissues were conducted after three months and six months of product use. RESULTS: One-hundred and ten (110) subjects complied with the protocol and completed the six-month study. After six months of product use, the Test Mouthwash group exhibited statistically significant reductions from baseline with respect to Gingival (33.5%), Gingival Interproximal (34.5%), Gingival Severity (63.2%), Plaque (33.6%), Plaque Interproximal (30.0%), and Plaque Severity (73.6%) Index scores. After six months of product use, the Control Mouthwash group exhibited statistically significant increases from baseline with respect to Gingival (6.9%), Plaque Interproximal (7.2%), and Plaque Severity (32.7%) Index scores. Furthermore, after six months of product use, the Control Mouthwash group exhibited reductions from baseline with respect to Plaque (6.1%), Gingival Interproximal (3.6%), and Gingival Severity (1.1%) Index scores which were not statistically significant. After three months of product use, the Test Mouthwash group exhibited statistically significant reductions in Gingival (25.0%), Gingival Interproximal (22.3%), Gingival Severity (38.9%), Plaque (26.1%), Plaque Interproximal (22.4%), and Plaque Severity (75.0%) Index scores as compared to the Control Mouthwash group. After six months of product use, the Test Mouthwash group exhibited statistically significant reductions in Gingival (38.1%), Gingival Interproximal (37.1%), Gingival Severity (63.6%), Plaque (36.5%), Plaque Interproximal (33.2%), and Plaque Severity (78.5%) Index scores as compared to the Control Mouthwash group. CONCLUSION: The results of this double-blind clinical study support that 1) an alcohol-free mouthwash containing a combination of 0.075% CPC and 0.05% NaF produces statistically significant reductions in dental plaque and gingivitis after three and six months compared to baseline, and 2) the alcohol-free CPC mouthwash provides a statistically significantly greater level of efficacy in controlling established dental plaque and gingivitis after three and six months of product use as compared to the Control Mouthwash containing only NaF.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.000 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".