An interventional study of Atraumatic Restorative Treatment and Hall technique in Healthy, sponsored by Cairo University. Not yet recruiting. Open to participants aged 4 Years to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-15.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to assess the time of treatment of Hall Technique versus Atraumatic Restorative Technique in the management of carious primary molars. The main questions it aims to answer are:
Participants will:
Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Exclusion Criteria:
Procedure: Atraumatic Restorative Treatment
Procedure: Hall technique
A sharp excavator will be used to remove soft demineralized carious tissue from the patient\'s primary molar 2-The molar will then be restored with capsulated Glass Ionomer in accordance to ART procedure. 3-Each capsule will be mixed for ten seconds and used for restoring teeth isolated by cotton rolls. 4-After the cement is cured, excess material will be removed with an excavator and a carver. 5-The occlusion will be tested for interferences with carbon paper. A layer of varnish coat will be applied to the surface and light-cured for 20 seconds .
The procedure involves assessing the occlusion, contact points, and tooth shape. If contact points are present, orthodontic separators will be placed between the primary molars to create space for crown fitting, with the child seated upright to maintain airway safety. After 3 to 5 days, the separators will be removed, and loose plaque and debris will be cleared. The correct crown size will be selected, ensuring it doesn't impinge on adjacent teeth, and will be filled with glass ionomer cement. The child will be instructed to bite down for two minutes to ensure proper seating. Excess cement will be removed, and contacts will be flossed. Any initial occlusal discrepancies are expected to resolve within weeks.
time of treatment
Time will be measured from the start of the procedure till its end using digital chronometer as a device and minutes as a unit.
Time frame: during the procedure
Postoperative Pain and discomfort
Immediately after the treatment, any pain and discomfort experienced by the child will be recorded using the Face Pain Scale - revised (FPS-R), which has six numbered faces from 0 to10 The (FPS-R). Each child will be asked to mark the face that reflects her or his experienced pain during the treatment. There is no pain visible on this face \[indicating the face on the far left\]. As you move from left to right, the faces get progressively more painful until you reach this one, which is incredibly painful \[indicating the face on the far right\]. The (FPS-R) faces will be scored as 0-2-4-6-8-10.
Time frame: immediately after the procedure , 3month ,6 month and 12 month
Child behavior
At the end of the treatment session, the dentist classifies the child's behavior during the treatment according to Venham Behavior Rating Scale is a reliable system for rating behavior of children in the dental setting. ratings will be scored as 0-1-2-3-4-5
Time frame: during the procedure
Canine overbite: HT
the canine overbite will be measured only for the hall technique group. The canine overbite will be measured before the procedure using a Boley Gauge, either on the same side or the opposite side if the canine is missing. After assessing tooth shape and occlusion, a stainless-steel crown (SSC) will be partially seated on the tooth with glass ionomer cement. The child will bite on a cotton roll to fully seat the crown, after which excess cement will be removed, and the overbite will be recorded immediately after treatment.
Time frame: preoperatively , immediately after the procedure , 3 month , 6 month, 12 month
Child anxiety
At the end of the treatment session, the dentist classifies the child's anxiety during the treatment according to Venham Anxiety Rating Scale is a reliable system for rating anxiety of children in the dental setting. ratings will be scored as 0-1-2-3-4-5
Time frame: during the procedure
No study locations are listed for this record.
This study is not yet recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Cairo University