Characteristics of phase 4 clinical trials on Dental Caries registered at Clinicaltrials.gov.

Background: Dental caries, a widespread chronic oral disease, is caused by multiple factors including microorganisms, genetic predisposition. Despite being preventable, it poses a significant global burden. This study reviews all phase 4 clinical trials on dental caries registered at ClinicalTrials.gov to provide a comprehensive overview of their characteristics.

Methods: A search was conducted on the ClinicalTrials.gov database using keywords. The registration data for all relevant phase 4 studies concerning 'Dental Caries' were retrieved. This search was conducted on the 23rd of January, 2024.

Results: The analysis included 58 phase 4 clinical trials, with most studies (67.2%) reporting complete data. The majority (63.8%) had fewer than 100 participants, and the predominant sponsors were medical institutions (77.6%). Geographically, the highest percentage of studies were conducted in South America (24.1%), with the lowest in North America (10.3%). Interventional trials primarily focused on treatment (51.7%) and prevention (41.4%), with a significant portion being randomized (93.1%). Blinding varied, with single and double blinding each used in 25.9% of studies. Drug interventions were the most common (60.6%), followed by other categories such as dietary supplements and procedures. Among drug interventions, agents containing fluoride were the largest category, accounting for 52.6% of the trials. Fluoride varnishes and silver diamine fluoride were the most frequently evaluated. Sedatives and pain relievers constituted 15.7% of the trials, with midazolam and ketamine being predominant. Other drugs accounted for 23.2% of the trials, featuring diverse substances such as inactivated poliovirus vaccine and xylitol. Dental materials and operative treatments made up 29.5% of the trials, with resin and fissure sealants being the most commonly evaluated.

Conclusion: This analysis of phase 4 clinical trials highlighted fluoride as the most studied intervention for dental caries prevention. The analysis also revealed a need for further research on non-fluoride interventions and emphasized the importance of using evidence-based practices in dental care for improved oral health outcomes.

Clinical trial number: Not applicable.