Effectiveness of Silver Diamine Fluoride (SDF) in Arresting Cavitated Caries Lesions
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|ClinicalTrials.gov Identifier: NCT03649659|
Recruitment Status : Recruiting
First Posted : August 28, 2018
Last Update Posted : October 22, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cavities of Teeth||Drug: Silver Diamine Fluoride Drug: Placebo||Phase 3|
This trial is a phase III, multicenter, randomized, placebo-controlled superiority trial, with two parallel groups (placebo vs. SDF applied to cavitated lesions) involving a total of 1060 children with the primary outcome assessed at 6 months after initial treatment.
One thousand sixty children, 23-61 months of age, from early childhood education programs, such as Head Start centers, Early Head Start centers, and equivalent city/state subsidized preschool programs, or children attending dental clinics associated with the clinical trial sites, will be randomized, in two cohorts. The plan to enroll in two cohorts, one at the beginning of each school year, is intended to address the feasibility and ability to recruit the total number of participants required. Each cohort will be followed for 8 months. Trial enrollment will occur over a course of 2 ½ years. Trial visits will occur at baseline, 3 months, 6 months, and 8 months. SDF/placebo will be applied at baseline and 6 months. Parents/legal guardians will be called 24 to 48 hours after the SDF/placebo application to assess adverse events and unanticipated problems and in-person visits for safety exams will be available for all child participants approximately 24 to 48 hours after SDF/placebo application. This visit could happen before or after the 24- to 48-hour call with the parent or legal guardian, but every attempt will be made so that the call occurs prior to the 24- to 48-hour visit. Additionally, intermediate contacts at 1.5 months, 4.5 months, and 7 months will occur to determine if the child needs an additional visit to assess pain, lesion progression, etc. and to maintain contact with the participant.
Randomization to SDF application (treatment) or placebo (control) will be at the participant-level; all teeth within a participant that meet the inclusion criteria will receive the same trial product. Both treatment and control will be dispensed from identical unit-dose ampules coded and labeled to ensure masking of all trial personnel. The number of ampules required to treat all carious lesions in the participant's mouth will be recorded. No caries removal will be performed. Teeth will be cleaned with a toothbrush and will be dried with cotton/gauze, and the solution will be painted on the dentin of each targeted cavitated lesion using a standardized applicator. Following application, the tooth will be blotted dry with gauze.
At each clinical visit International Caries Detection and Assessment System (ICDAS) examinations, including cavitated lesion hardness assessments, soft tissue assessments and questionnaires on dental discomfort, family impact and treatment satisfaction and acceptability will be collected.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1060 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Phase III RCT of the Effectiveness of Silver Diamine Fluoride in Arresting Cavitated Caries Lesions|
|Actual Study Start Date :||October 8, 2018|
|Estimated Primary Completion Date :||April 30, 2020|
|Estimated Study Completion Date :||June 30, 2020|
Experimental: Silver Diamine Fluoride (SDF)
SDF will be applied to the affected teeth twice during the study. Once at screening/baseline and again at the 6-month visit.
Drug: Silver Diamine Fluoride
SDF will be applied twice during the study
Other Name: Diammine Silver Fluoride
Placebo Comparator: Placebo
The placebo will be applied to the affected teeth twice during the study. Once at screening/baseline and again at the 6-month visit.
This is being compared to the SDF and will also be applied twice
- The proportion of arrested trial lesions per child in each treatment arm after one treatment with SDF or Placebo [ Time Frame: 6 months ]Arrested trial lesions will be assessed by determining if the lesion is hard or soft by pressing on the lesion using a standard probe as assessed by calibrated examiners.
- The proportion of arrested trial lesions per child in each treatment arm after two treatments with SDF or Placebo [ Time Frame: 8 months ]Arrested trial lesions will be assessed by determining if the lesion is hard or soft after two SDF applications by pressing on the lesion using a standard probe as assessed by calibrated examiners.
- Change in proportion of arrested trial lesions per child in each treatment arm after one treatment with SDF or Placebo [ Time Frame: 3 months and 6 months ]Change in proportion of arrested trial lesions will be assessed by determining if the lesion is hard or soft by pressing on the lesion using a standard probe as assessed by calibrated examiners. The effect of a single application will be assessed at 3-month follow-up versus the 6-month follow-up post initial treatment.
- Proportion of Children in Each Treatment Arm experiencing Toothache Pain [ Time Frame: Baseline, 24-48 hour call, 1.5 month, 3 month, 4.5 month, 6 month, 24-48 hours after 6 month, 7 month, 8 month ]The presence of pain associated with a trial tooth will be defined as a score of 1 or higher using the Dental Discomfort Questionnaire (DDQ), which can be associated with a trial tooth during a clinical visit. The DDQ is a validated tool that assesses pain in children 5 and younger, as reported by parents/legal guardians as proxies, based on the observation of toothache pain-related behaviors by the child. It consists of two parts. The first part includes a question concerning the occurrence of toothache and when (if no pain DDQ score of 0, best). The second part consists of 8 validated questions about different behaviors associated with toothache or discomfort due to caries. Each item can be answered on a three-point scale: 0 'never', 1 'sometimes', and 2 'often'. If there is toothache the total score is calculated by adding the scores to the 8 questions in part two, and ranges from 0 (no pain) to 16 (worse score).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03649659
|Contact: Emily Yancaemail@example.com|
|Contact: Elizabeth Pitts, RDH, MSfirstname.lastname@example.org|
|United States, Iowa|
|University of Iowa College of Dentistry||Recruiting|
|Iowa City, Iowa, United States, 52242|
|Contact: Sara Miller, MPH 319-335-8807|
|United States, Michigan|
|University of Michigan School of Dentistry||Recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Contact: Elizabeth Pitts, RDH, MS 734-615-8270|
|United States, New York|
|New York University College of Dentistry||Recruiting|
|New York, New York, United States, 10010|
|Contact: Ahmed El Sayed 321-754-0656|
|Principal Investigator:||Margherita Fontana, DDS, PhD||University of Michigan|