Clinical Efficiency and Treatment Failure of Hall Versus SDF Techniques in the Management of Carious Primary Molar.

Clinical Efficiency and Treatment Failure of Hall Versus SDF Techniques in the Management of Carious Primary Molar: Randomized Clinical Trial.

Sponsors

Lead Sponsor: Cairo University

Source Cairo University
Brief Summary

This study will compare two non- invasive treatment options: Hall technique and 38% Silver diamine fluoride. Both are methods used to create a more favorable environment without removal of caries leading to the arrest of the progression of demineralization process and restoring the function of the diseased molars.

Detailed Description

Detailed Description: Dental caries, also known as tooth decay, it can occur in primary teeth in early childhood, is formed through interaction between acid-producing bacteria and carbohydrate. The caries develops in both the crowns and roots of teeth. Progress of caries depended on the lifestyle of the child (as high numbers of cariogenic bacteria, inadequate salivary flow, insufficient fluoride exposure and poor oral hygiene). To avoid this disease should follow the proper oral hygiene and improve lifestyle . A lot of methods found to treatment the decayed tooth - like; Hall technique and Silver diamine fluoride The first report on the Hall Technique published in 2007 by a general dental practitioner from Aberdeen/Scotland, Dr. Norna Hall. Dr. Hall used PMCs to restore carious primary molars rather than using the standard technique, placed them using a simplified method2 Previous studies have recommended that Silver diamine fluoride (SDF) solution would exert a preventive result in managing early childhood caries ECC. However, no well-designed clinical trials have yet been performed to study the effect of SDF on caries prevention. the objective is useful in arresting early childhood caries (ECC)

Overall Status Not yet recruiting
Start Date May 1, 2021
Completion Date September 1, 2022
Primary Completion Date September 1, 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
percentage of Treatment failure: one year
Secondary Outcome
Measure Time Frame
Canine overbite one year
Arresting caries in SDF one year
Enrollment 120
Condition
Intervention

Intervention Type: Procedure

Intervention Name: SDF

Description: 1)Dry with cotton to affected tooth surfaces 2) Apply the SDF material 3)Dry with a gentle flow of compressed air for at least one minute. and Remove excess SDF with gauze

Arm Group Label: SDF

Other Name: Silver Diamine Fluoride

Intervention Type: Procedure

Intervention Name: Hall technique

Description: Orthodontic separator being stretched between two pieces of floss, then placed between the contact points of primary molars (for five days.) 2)The correct size of crown will not impinge on the teeth on either side, and a slight 'spring back' will be felt when the PMC is gently pushed up

Arm Group Label: Hall Technique

Eligibility

Criteria:

Inclusion Criteria: - Age: From 4 to 6 years - Caries in primary molars within enamel/dentin without pulp disease Exclusion Criteria: - Presence of signs and symptoms of necrosis - Root caries - Spontaneous pain

Gender: All

Minimum Age: 4 Years

Maximum Age: 6 Years

Healthy Volunteers: No

Overall Contact

Last Name: gihan abo el neil,, professor

Verification Date

February 2021

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Cairo University

Investigator Full Name: Mostafa Amin Mahmoud El.byoumi

Investigator Title: principle investigator

Keywords
Has Expanded Access No
Number Of Arms 2
Arm Group

Label: Hall Technique

Type: Active Comparator

Description: The Hall Technique is a non-invasive treatment for decayed molar teeth. Decay is sealed under preformed (stainless steel) crowns, avoiding drilling

Label: SDF

Type: Experimental

Description: a clear liquid that combines the antibacterial effects of silver and the remineralizing effects of fluoride, is a topical therapeutic agent for managing caries lesions in young children

Patient Data Yes
Study Design Info

Allocation: Non-Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Masking Description: not possible, since interventions are different

Source: ClinicalTrials.gov