Application of SDF Verses NaF Varnish in Treatment of Carious Primary Teeth
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03554980|
Recruitment Status : Not yet recruiting
First Posted : June 13, 2018
Last Update Posted : June 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Dental Caries in Children||Drug: Silver Diamine Fluoride Drug: Sodium Fluoride varnish||Phase 4|
Untreated dental decay and poor access to dental care are significant Public health problems for children in the world (Dye et al. 2015 and Horst, 2016). Early childhood caries is a multifactorial, infectious and transmissible dental disease affecting young children . Conventional restorative treatment may fail to reduce the burden of early childhood caries in many parts of the world. Most decayed teeth in preschool children remained unrestored . Consequences of untreated decay in preschool children may include increased risk of future caries in primary and permanent dentition, pain and infections; increased expensive emergency room visits and hospital admissions; increased treatment costs because of extensive decay and the accompanying need for general anesthesia; delayed growth and development; and missed days from school and work .To reduce the burden of caries disease in young children and to avoid possible serious consequences of untreated decay, it is important to identify an effective, low-cost method of treating caries in children at high risk of caries and with limited access to dental care. Silver diamine fluoride (SDF) has been identified as an anticariogenic agent that successfully arrests dental decay and has the potential to address the epidemic of untreated decay in young children
Therefore this study will be conducted to assess the postoperative pain after application of silver diamine fluoride versus sodium fluoride varnish in treatment of carious primary teeth.
Benefits of the research to the patient:
According to American Academy of Pediatric Dentistry (AAPD), 2017 SDF application is:
- Effective in dental caries management, especially arresting cavitated caries lesions in the primary dentition.
Benefits of the research to the clinician:
According to AAPD, 2017 SDF is:
- Easily performed.
- A promising strategy to manage dental caries in very young children or those who have special needs.
- Doesn't require cooperation from children during dental treatment.
It will improve patient confidence with the dentist
Explanation for choice of comparators:
The use of sodium fluoride is well documented in the literature as successful caries arrestment material. Arrestment proportion of caries for sodium fluoride varnish was found to be 84.4% (NaF) and 85.3% for ( NaF + chlorohexidine mouth wash) .
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||46 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||patient will receive either Silver Diamine Fluoride or Sodium Fluoride varnish according to the allocation ratio|
|Masking:||Double (Participant, Outcomes Assessor)|
|Masking Description:||Double (participant, Outcomes Assessor)|
|Official Title:||Postoperative Pain After Application of Silver Diamine Fluoride Verses Sodium Fluoride Varnish in Treatment of Carious Primary Teeth (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 at 0,1,3,6, 9 and 12.
SDF is a 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 patients 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
- Postoperative Pain [ Time Frame: 12 months ]Postoperative pain will be assessed through questioning the patient and/or parent .Binary (Yes or No)
- Parental satisfaction [ Time Frame: 12 months ]Parental satisfaction will be assessed through questioning the parent. Binary (yes or no)
- Caries arrest (dentin texture) Cries arrest (Dentine texture) [ Time Frame: 12 months ]Caries arrest will be assessed through tactile examination (hard or soft). Categorical
- Discoloration (yellow, brown, black) [ Time Frame: 12 months ]Discoloration will be assessed through visual examination. Categorical
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): NCT03554980
|Contact: Marwa A Salmoon, MScfirstname.lastname@example.org|
|Contact: Fatma KI Abdelgawad, Lectureremail@example.com|
|Pediatric Dentistry, Faculty of Dentistry, Cairo University|
|Study Chair:||Nevine G Waly, Professor||Pediatric Dentistry, Faculty of Dentistry, Cairo University|
|Study Director:||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:||Marwa A Salmoon, MSc||Pediatric Dentistry, Faculty of Dentistry, Cairo University|