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NCT Number: NCT05265104

Laser Versus Silver Diamine Fluoride in Hall Technique in Primary Teeth

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

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Key information

Age range

4 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Rasha Farouk Sharaf

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SDF with stainless steel crown

Drug

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

Diode laser application with stainless steel crown

Device

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

stainless steel crown only

Other

the primary molars with carious lesions will be sealed with stainless steel crowns following the concept of hall technique

Primary outcomes

  1. Pain on biting

    Time frame: 1 year

    Verbal questioning of the patient

  2. gingival swelling

    Time frame: 1 year

    visual examination by the operator

Secondary outcomes

  1. Periapical/ furcation radiolucency

    Time frame: 1 year

    perapical radiograph using paralleling technique by DE GOTZEN XGENUS intra-oral x ray unit

Sponsors and collaborators

Lead sponsor

National Research Centre, Egypt

Other

Registry information

Official study title

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

Acronym: SDF

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 3, 2022
Registry last updated
Jun 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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