Laser Versus Silver Diamine Fluoride in Hall Technique in Primary Teeth

Carious Teeth Clinical Trial

— SDF  

Official title:

Clinical and Radiographic Evaluation of the Efficacy of Laser Versus Silver Diamine Flouride (SDF) in Hall Technique in Primary Teeth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05265104
• Other study ID #: 1434052021
• Status: Completed
• Phase: N/A
• Start date: March 10, 2021
• Est. completion date: April 30, 2022

Study information

• Verified date: June 2024
• Source: National Research Centre, Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The hall technique for primary teeth depends on the idea of isolation of the carious non exposed primary tooth from all bacteria present in the oral cavity by using a stainless-steel crown which result in arresting of the caries and preventing its progress to the pulp. Recently laser and Silver Diamide Fluoride (SDF) have been used to arrest the progress of caries so in the current study we will compare the success rate of hall technique with either laser or SDF in arresting of caries

Description:

The high frequency of caries in primary teeth and its inadequate treatment are major public health problems during childhood. Nowadays, the Hall technique is one of the methods used for biological sealing in carious lesions in primary molars. Thus, the bacteria will be sealed from oral environment and the caries will be inactive. Using the Hall technique, the crown is placed without local anesthesia, caries removal, or tooth preparation. Then, the crown is fitted over the carious primary molar by either the dentist's finger pressure, or the child's biting force. The average results of many clinical trials showed that the success rates of the Hall technique were greater than the conventional restorations. However, some criteria of minor failures were seen in 26.6% of Hall crowns. Silver diamine fluoride (SDF), a clear liquid that combines the antibacterial effects of silver and the remineralizing effects of fluoride, is a promising therapeutic agent for managing caries lesions in young children, its effectiveness in reducing specific cariogenic bacteria and its remineralizing potential on enamel and dentin have been reported in many studies. Recently, lasers have been proven to significantly arrest the dental caries by increasing the acid resistance of the enamel with an antibacterial effect. Diode lasers with several positive aspects, such as the small size, low cost, and ease of use in the oral cavity, were found to have a caries prevention and arrest effect on the dental enamel, particularly deciduous teeth. In the current study the success rate of Hall technique using SDF will be compared to the same technique using Diode laser in arresting the carious lesions in primary teeth.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 7 Years

Eligibility

Inclusion Criteria:

• Patients should be medically free

• Presence of asymptomatic enamel and dentin caries in one or more primary molars, which can be detected clinically and radiographically

• Periapical radiograph should show caries involving the outer half of the dentin

• There should be no signs or symptoms of pulpal pathosis

Exclusion Criteria:

• Immunocompromised patients

• Presence of any signs or symptoms of pulpal pathosis denoting irreversible pulpitis

• Parents who are not willing to come in the follow up visits

Related Conditions & MeSH terms

• Carious Teeth
• Dental Caries

Intervention

Drug:
• SDF with stainless steel crown
Silver Diamine Fluoride (38%) applied to the carious lesion in the primary molars with a brush and the tooth is sealed with a stainless steel crown

Device:
• Diode laser application with stainless steel crown
Diode laser will be applied to the carious lesions primary molars to eradicate the bacteria and then the tooth will be sealed with stainless steel crown

Other:
• stainless steel crown only
the primary molars with carious lesions will be sealed with stainless steel crowns following the concept of hall technique

Locations

Country	Name	City	State
Egypt	Dr. Rasha Farouk Sharaf	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
National Research Centre, Egypt

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

Altoukhi DH, El-Housseiny AA. Hall Technique for Carious Primary Molars: A Review of the Literature. Dent J (Basel). 2020 Jan 17;8(1):11. doi: 10.3390/dj8010011. — View Citation

Chaurasiya A, Gojanur S. Evaluation of the clinical efficacy of 38% silver diamine fluoride in arresting dental caries in primary teeth and its parental acceptance. J Indian Soc Pedod Prev Dent. 2021 Jan-Mar;39(1):85-89. doi: 10.4103/jisppd.jisppd_34_21. — View Citation

Chokhachi Zadeh Moghadam N, Seraj B, Chiniforush N, Ghadimi S. Effects of Laser and Fluoride on the Prevention of Enamel Demineralization: An In Vitro Study. J Lasers Med Sci. 2018 Summer;9(3):177-182. doi: 10.15171/jlms.2018.32. Epub 2018 Jul 28. — View Citation

Clark W, Geneser M, Owais A, Kanellis M, Qian F. Success rates of Hall technique crowns in primary molars: a retrospective pilot study. Gen Dent. 2017 Sep-Oct;65(5):32-35. — 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain on biting	Verbal questioning of the patient	1 year
Primary	gingival swelling	visual examination by the operator	1 year
Secondary	Periapical/ furcation radiolucency	perapical radiograph using paralleling technique by DE GOTZEN XGENUS intra-oral x ray unit	1 year