Laser Versus Silver Diamine Fluoride in Hall Technique in Primary Teeth

Not Applicable

Completed

• Conditions: Carious Teeth
• Interventions: Drug: SDF with stainless steel crown; Other: stainless steel crown only; Device: Diode laser application with stainless steel crown

• Registration Number: NCT05265104
• Lead Sponsor: National Research Centre, Egypt

Brief 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

Detailed 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.

Study Timeline

• Study Start: 2021-03-10
• Study First Submitted: 2022-02-03
• Study First Submitted QC: 2022-02-22
• Study First Posted: 2022-03-03
• Primary Completion: 2022-04-30
• Study Completion: 2022-04-30
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-01
• Last Update Posted: 2024-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SDF with stainless steel crown	SDF with stainless steel crown	mixture of silver , diamine and fluoride applied using a brush to the caries in the primary molar , it is used to arrest the progress of the carious lesion
Control, stainless steel crown only	stainless steel crown only	stainless steel crown is cemented on the carious primary molar to arrest the progress of the caries, by isolating the tooth from the surrounding bacteria, this is the concept of the Hall technique.
Diode laser with stainless steel crown	Diode laser application with stainless steel crown	Diode laser beam is used to sterilize the carious lesions to arrest the progress of the dental caries

Primary Outcome Measures

Name	Time	Method
Pain on biting	1 year	Verbal questioning of the patient
gingival swelling	1 year	visual examination by the operator

Secondary Outcome Measures

Name	Time	Method
Periapical/ furcation radiolucency	1 year	perapical radiograph using paralleling technique by DE GOTZEN XGENUS intra-oral x ray unit

Trial Locations

Locations (1)

Dr. Rasha Farouk Sharaf; 🇪🇬 Cairo, Egypt