Discoloration of Carious Primary Teeth After Application of Silver Diamine Fluoride Versus Sodium Fluoride Varnish
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|ClinicalTrials.gov Identifier: NCT03557996|
Recruitment Status : Not yet recruiting
First Posted : June 15, 2018
Last Update Posted : June 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Dental Caries in Children||Drug: Silver Diamine Fluoride Drug: Sodium Fluoride Varnish||Phase 4|
The American Academy of Pediatric Dentistry's (AAPD) guidelines (2017) stated that Silver diamine fluoride (SDF) is a brush-on liquid that arrest 87.7% of dental caries lesions. The success rate is similar for restorations placed under GA. One of the most exciting aspects of SDF is the 67±4% decrease in new lesions on untreated surfaces, achieved simply by treating active lesions .This is not the same as incidence of any new lesions (elaborated above for treatment under GA), however the relation warrants further investigation.
Benefit to the patient
- No pain and infection.
- Enhance child cooperation.
- Enhance better patient compliance.
- Decrease cost of dental treatment and may eliminate the need for General Anesthesia.
Benefit to the dentist
- Develop an effective fast easy method to arrest the caries by using SDF.
- Ease of dental treatment.
- Better cooperation with the child.
- The procedure is simple.
- Inexpensive and non-invasive.
- It does not require expensive equipment or support infrastructure, such as pipe water or electricity.
Benefit to the population
- Reduce the harmful impact of oral health problems in preschool children from low income families.
- SDF can be considered a user-friendly material for use in dental clinics as well as remote areas, schools or deprived communities.
Children aged 2-5 years can benefit from the use of SDF, an easy anticaries treatment. Furthermore, children in this age group may benefit from delayed dental treatment and overall caries arrest, thus reducing potential pain and infection, expensive future emergency room visits, the need for general anesthesia or traumatic dental experiences on uncooperative children.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||patient will receive either silver diamine fluoride or sodium fluoride varnish|
|Masking:||Double (Participant, Outcomes Assessor)|
|Masking Description:||double (participant-outcome assessor)|
|Official Title:||Discoloration of Carious Primary Teeth After Application of Silver Diamine Fluoride Versus Sodium Fluoride Varnish: A Randomized Clinical Trial|
|Estimated Study Start Date :||December 1, 2018|
|Estimated Primary Completion Date :||November 1, 2019|
|Estimated Study Completion Date :||June 1, 2020|
Experimental: Group 1
38% silver diamine fluoride liquid will be applied twice annually and patients will be followed up as 0,1,3,6,9 and 12 SDF is brush on liquid
Drug: Silver Diamine Fluoride
SDF will be applied with a brush
Other Name: SDF
Active Comparator: Group 2
5% Sodium fluoride varnish will be applied four times annually and patient will be followed up at 0,1,3,6,9 and 12
Drug: Sodium Fluoride Varnish
NaF will be applied with a brush
Other Name: NaF varnish
- Discoloration [ Time Frame: 12 months ]Discoloration will be assessed by questioning the patient and/or the guardian.binary (yes or no)
- Investigator reported discoloration [ Time Frame: 12 months ]Investigator will report the discoloration occurred to treated teeth (yellow, brown, black) Visual examination
- Timing of discoloration [ Time Frame: 12 months ]Visual examination at follow up
- Caries arrest (dentine texture) [ Time Frame: 12 months ]Caries arrest will be assessed through tactile examination (Soft or hard) Tactile examination
- Postoperative Pain: Questioning the patient [ Time Frame: 12 months ]Questioning the patient and/or the parentBinary (yes or No)
- Parental satisfaction: Questioning the parent [ Time Frame: 12 months ]Questioning the parent
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): NCT03557996
|Contact: Yousra M Abdel Rehim, MScemail@example.com|
|Contact: Fatma KI Abdelgawad, Lecturerfirstname.lastname@example.org|
|Pediatric Dentistry, Faculty of Dentistry, Cairo University||Not yet recruiting|
|Contact: Fatma KI Abdelgawad, Lecturer 01006753265 email@example.com|
|Principal Investigator: Yousra M Abdel Rehim, MSc|
|Sub-Investigator: Fatma KI Abdelgawad, Lecturer|
|Sub-Investigator: Nevine G Waly, Professor|
|Sub-Investigator: Eman S Elmasry, Professor|
|Study Director:||Nevine G Waly, Professor||Pediatric Dentistry,Faculty of Dentistry, Cairo University|
|Study Chair:||Eman S Elmasry, Professor||Pediatric Dentistry, Faculty of Dentistry, Cairo University|
|Study Director:||Fatma KI Abdelgawad, Lecturer||Pediatric Dentistry, Faculty of Dentistry, Cairo University|
|Principal Investigator:||Yousra M Abdel Rehim, MSc||Pediatric Dentistry, Faculty of Dentistry, Cairo University|