Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-25 @ 2:44 AM
NCT ID:
NCT07245433
Brief Summary:
This clinical study evaluates whether cleaning infants' and toddlers' teeth and gums with xylitol-containing wipes can help reduce oral bacteria associated with early childhood caries. A total of 20 healthy children aged 9 to 18 months are enrolled. Mothers are instructed to clean their children's teeth and gums using xylitol dental wipes three times daily after meals for four weeks. Saliva samples are collected at baseline and during weekly follow-up visits to measure lactic acid levels and mutans streptococci counts. A pediatric dentist examines each child at every visit to monitor general oral health and to check for any potential side effects. The study aims to assess the feasibility, safety, and potential preventive value of parent-applied xylitol wipes during early childhood.
Detailed Description:
This longitudinal interventional study is designed to assess the preventive effect of xylitol-containing dental wipes on oral bacteria linked to early childhood caries (ECC). The study enrolls 20 healthy, caries-free infants and toddlers aged 9 to 18 months attending the Pediatric Dentistry Department, Faculty of Dentistry, Alexandria University. After obtaining informed consent, mothers are instructed to use commercially available xylitol dental wipes (Spiffies Baby Tooth Wipes™, Dr. Products Inc., USA) to clean their children's teeth and gums three times daily after meals for four consecutive weeks. Each wipe contains a xylitol-based solution intended to provide mechanical cleaning and daily exposure to approximately 4.2 g of xylitol.
Saliva samples are collected at baseline and at four weekly follow-up visits. Two primary outcome measures are assessed:
Lactic acid levels, using the Clinpro Cario-L-Pop chairside kit (3M ESPE, Germany) Mutans streptococci counts, using the CRT Bacteria Caries Risk Test (Ivoclar Vivadent, Liechtenstein) Participants are monitored weekly to assess compliance, document any dietary changes, and report potential side effects, including mild gastrointestinal symptoms. Children undergo oral examinations by a pediatric dentist at each visit to evaluate oral tissues and overall tolerance of the intervention.
The study protocol focuses on determining whether the regular use of xylitol wipes is feasible, acceptable to parents and children, and potentially useful as a preventive measure against early childhood oral bacterial activity.
Study:
NCT07245433
Study Brief:
Protocol Section:
NCT07245433