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Search / Trial NCT05772039

Treatment of Early Childhood Caries Using Silver Diammine Fluoride and Sodium Fluoride Tricalciumphosphate and the Effects on Oral Health Related Quality of Life

Launched by UNIVERSITI SAINS MALAYSIA · Mar 5, 2023

Trial Information

Current as of August 02, 2025

Unknown status

Keywords

Sdf Na F F Tcp Child Behavior Pain Experience Wong Baker Faces Pain Rating Scale Oral Health Related Quality Of Life Caries Arrest Caries Prevention Silver Diammine Fluoride Minimal Intervention Dentistry Functionalized Tricalcium Phosphate Sodium Fluoride

ClinConnect Summary

Although SDF has been proven to be highly effective in carious lesion arrest and prevention, the staining effect, metallic taste due to silver content and the minimal mucosal irritation have been noted as primary cause of disinterest among clinicians in the use of this material.

The use of NaF-fTCP as a caries preventive material has not been studied widely. The importance of oral hygiene education and diet modification to achieve an effective caries control has been widely discussed. The off-label use of NaF-fTCP as a caries arresting agent has not been studied on primary dentition. There...

Gender

ALL

Eligibility criteria

  • Inclusion criteria:
  • Children will be invited to participate in the trial if they fulfil the entire selection criteria as described below:
  • 4 to 6 years-of-age
  • Identification of one or more carious primary molars without involvement of the pulp confirmed by bitewing radiographs
  • Up to three teeth per each participant will be selected for intervention
  • Has normal salivary flow rate
  • Does not consume medications regularly for any medical condition
  • Has not or will not receive any fluoride therapy or relevant dental therapy from other dental sources within the last six months
  • Exclusion criteria:
  • Children will be excluded from the trial if they fulfil any of the following criteria:
  • Presence of any pain, ulceration, fistula/sinus or an abscess
  • Premature hypermobility of carious teeth which can be potentially included in the study
  • History of allergy to any product containing silver compounds
  • Siblings of the participants will not be allowed to participate to ensure any chance of ECOHIS duplication.

About Universiti Sains Malaysia

Universiti Sains Malaysia (USM) is a leading research university in Malaysia, renowned for its commitment to advancing scientific knowledge and innovation in the healthcare sector. As a clinical trial sponsor, USM leverages its multidisciplinary expertise and state-of-the-art facilities to conduct rigorous research aimed at improving patient outcomes and addressing pressing health challenges. The university fosters collaboration among researchers, medical professionals, and industry partners, ensuring that its clinical trials are conducted with the highest ethical standards and scientific integrity. Through its dedication to excellence in research and education, USM plays a pivotal role in shaping the future of healthcare both locally and globally.

Locations

Lahore, Punjab, Pakistan

Patients applied

0 patients applied

Trial Officials

Anas Imran Arshad, MSc., BDS

Principal Investigator

Universiti Sains Malaysia

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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