Assessing Parental Acceptance to Silver Diamine Fluoride Staining Before and After Masking the Colour With Glass Ionomer

Caries Arrested Clinical Trial

Official title:

"Parental Perception and Acceptance of the Utilization of Silver Diamine Fluoride on Their Child's Anterior and Posterior Teeth Before and After Masking the Colour With Glass Ionomer"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04509232
• Other study ID #: PED1931M
• Status: Completed
• Phase: N/A
• Start date: October 12, 2019
• Est. completion date: September 22, 2021

Study information

• Verified date: September 2021
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Assessing Parents acceptance for the colour of Silver Diamine Fluoride on their Children anterior and posterior teeth before and after masking its colour with Glass Ionomer.

Description:

Sample size estimation Sample size estimation was based on the primary outcome of interest The final sample size was 41 children per group (total sample size = 82 children)

Patients will be recruited randomly from outpatient clinic of the Department of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Ain Shams University. A signed informed consent to the parents' and also an insent to child,outlined by the Ethical Committee, Faculty of Dentistry, Ain Shams University will be obtained before the conduction of the study.

All examination procedures will be done by the same operator to ensure standardization.

Moreover, all patients will receive oral health education in regard to dietary and oral hygiene habits.

Excluded carious primary molars will be scheduled to receive the appropriate treatment.

Before applying any procedures medical history for any silver products allergy (SDF allergy) will be assessed by asking the child's parent.

Materials:

38%SDF

Conditioner 3M ESPE

High strength hand mix chemical cure glass ionomer

Patient withdrawal

Patient who don't comply to the oral hygiene given will be excluded from the study.

Patients who are not willing to continue in the study will have the right to quit at any time without loss of any benefits.

Data Management

Patient information will be gathered and stored in the patient examination chart of the outpatient clinic, Department of Pediatric Dentistry, faculty of Dentistry, Ain Shams University.

All information will be kept as a hard copy and as an electronic one as well. Patient information will be guarded as confidential information that should never be revealed at all times.

Adverse Event Reporting

SDF is not expected to have any adverse effects on healthy subjects, yet failure of treatment, recurrent caries, abcess formation or pulpal affection may be an issue of concern, that will be avoided by the continuous follow up sessions.

Statistical Analysis

Sample size estimation was based on the primary outcome of interest, which is to test whether there's a significant difference in parent satisfaction between the parents of children receiving SDF and those receiving SDF followed by ART restorations. The predicted sample size for comparing parent satisfaction score was found to be 34 children per group (total sample size = 68 children), by assuming an α level of 0.05 and β level of 0.2 (power = 80%). The effect size d was calculated based on the findings of M. Jiang, et al., and the allocation ratio was set at 1. After adjusting for 20% dropout, the final sample size was 41 children per group (total sample size = 82 children). Sample size calculation was performed using G*Power software version 3.1.4 for MS Windows.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: September 22, 2021
• Est. primary completion date: July 22, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 7 Years

Eligibility

Inclusion Criteria:

1. Uncooperative patients.

2. Patients whom their parents refuse or cannot afford the cost of GA surgeries.

3. Teeth that are restorable with restoration and doesn't need full coverage.

4. Teeth which are free of symptoms of pulpal pathology.

5. Children with anterior and posterior carious teeth with minimum of two teeth.

Exclusion Criteria:

1. Patients whom their parents totally refuse Silver diamine fluoride staining .

2. Children suffering from any medical condition that can't be managed in the clinic.

3. Children with known allergies to silver products.

4. Children with severe forms of hypoplasia .

Related Conditions & MeSH terms

• Caries Arrested
• Heart Arrest

Intervention

Procedure:
• Silver diamine fluoride
Group A Excavation of soft carious dentin will be done to minimize the staining. The selected teeth should be cleaned, dried and isolated. Vaselline should be applied to surrounding soft tissues to avoid their staining.- 38% Silver diamine fluoride will be applied to carious lesions by microbrush Apply gentle flow of air until medicament is dry, Try to keep isolated for three minutes,remove excess SDF with cotton pellet to decrease systemic absorption. After silver diamine fluoride application Assessement of parental acceptance to staining will be done though a 5 point likert scale For anterior and posterior teeth separately .
• Silver diamine fluoride and glass ionomer
38% Silver diamine fluoride will be applied by the same protocol as in group A Then Glass Ionomer restoration is applied Parental acceptance to staining will be assessed thought 5 point likert scale after application of SDF and once more after application of Glass Ionomer restoration.

Locations

Country	Name	City	State
Egypt	Ainshams university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Dina Bassam Mohamed Ahmed

Country where clinical trial is conducted

Egypt, 

References & Publications (12)

Alshammari AF, Almuqrin AA, Aldakhil AM, Alshammari BH, Lopez JNJ. Parental perceptions and acceptance of silver diamine fluoride treatment in Kingdom of Saudi Arabia. Int J Health Sci (Qassim). 2019 Mar-Apr;13(2):25-29. — View Citation

Anil S, Anand PS. Early Childhood Caries: Prevalence, Risk Factors, and Prevention. Front Pediatr. 2017 Jul 18;5:157. doi: 10.3389/fped.2017.00157. eCollection 2017. Review. — View Citation

Burgess JO, Vaghela PM. Silver Diamine Fluoride: A Successful Anticarious Solution with Limits. Adv Dent Res. 2018 Feb;29(1):131-134. doi: 10.1177/0022034517740123. Review. — View Citation

Caries-risk Assessment and Management for Infants, Children, and Adolescents. Pediatr Dent. 2018 Oct 15;40(6):205-212. — View Citation

Chu CH, Lee AH, Zheng L, Mei ML, Chan GC. Arresting rampant dental caries with silver diamine fluoride in a young teenager suffering from chronic oral graft versus host disease post-bone marrow transplantation: a case report. BMC Res Notes. 2014 Jan 3;7:3. doi: 10.1186/1756-0500-7-3. — View Citation

Clemens J, Gold J, Chaffin J. Effect and acceptance of silver diamine fluoride treatment on dental caries in primary teeth. J Public Health Dent. 2018 Dec;78(1):63-68. doi: 10.1111/jphd.12241. Epub 2017 Jul 27. — View Citation

Crystal YO, Janal MN, Hamilton DS, Niederman R. Parental perceptions and acceptance of silver diamine fluoride staining. J Am Dent Assoc. 2017 Jul;148(7):510-518.e4. doi: 10.1016/j.adaj.2017.03.013. Epub 2017 Apr 27. — View Citation

Crystal YO, Niederman R. Evidence-Based Dentistry Update on Silver Diamine Fluoride. Dent Clin North Am. 2019 Jan;63(1):45-68. doi: 10.1016/j.cden.2018.08.011. Review. — View Citation

Innes NP, Manton DJ. Minimum intervention children's dentistry - the starting point for a lifetime of oral health. Br Dent J. 2017 Aug 11;223(3):205-213. doi: 10.1038/sj.bdj.2017.671. — View Citation

JUCSF protocol for caries arrest using silver diamine fluoride: rationale, indications, and consent. Br Dent J. 2017 Apr 7;222(7):516. doi: 10.1038/sj.bdj.2017.311. — View Citation

Policy on the Use of Silver Diamine Fluoride for Pediatric Dental Patients. Pediatr Dent. 2018 Oct 15;40(6):51-54. — View Citation

Zhao IS, Gao SS, Hiraishi N, Burrow MF, Duangthip D, Mei ML, Lo EC, Chu CH. Mechanisms of silver diamine fluoride on arresting caries: a literature review. Int Dent J. 2018 Apr;68(2):67-76. doi: 10.1111/idj.12320. Epub 2017 May 21. Review. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessement of Parental perception and Acceptance	Assessement of Parental Perception and Acceptance of the Utilization of Silver Diamine Fluoride on their Child's Anterior and Posterior Teeth before and after masking the colour with Glass Ionomer through 5 point likert scale; The format of the five-level Likert scale will be; Strongly disagree; Disagree; Neutral; Agree; Strongly agree	december 2019 to june 2021
Secondary	protocol for placement of silver diamine fluoride with minimal staining	Applying a protocol for placement of silver diamine fluoride with minimal staining as an alternative modality to general anesthesia for treatment of uncooperative patients in the department of pediatric dentistry Ain shams university.	december 2019 to june 2021