Evaluation Of Periodontal Health After Treatment With Hall Technique Versus Atraumatic Restorative Treatment in The Management of Carious Primary Molars

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-6
SponsorCairo University

About this trial

This trial seeks to evaluate the periodontal health of two modalities Hall Technique (by placing a stainless steel crown without caries removal, local anaesthesia won't be needed) \& ART (by removing caries by sharp excavator and restoring the tooth with glass ionomer, local anaesthesia won't be needed either) to achieve better treatment for caries with pain-free procedures in developing countries that have high caries index and low income.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age: From 4 to 6 years.

Caries in primary molars within enamel/dentin with vital pulp.

Healthy children.

Cooperative children.

Disqualifiers

Presence of signs and symptoms of necrosis.

Root caries.

History of Spontaneous pain.

Trial design

Design model

Parallel

Treatments tested in this trial

  • ART

    Procedure/Surgery

    Caries excavation with hand instruments only and restoration with glass ionomer filling

  • Hall technique

    Procedure/Surgery

    Stainless steel crown placement without tooth preparation

Treatment groups

46 Participants
are divided into 2 treatment groups
Group A: ARTExperimental treatment 1 intervention
Group B: Hall techniqueExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Periodontal health

While determining the plaque, the 4 surfaces of the teeth included in the study (mesial, distal, vestibule, lingual) using plaque index (0: no plaque, 2: thick visible plaque easily detected)

Time frame
initial, 3 months, 6 months, 12 months

Secondary outcomes

1

Gingival index

While determining the plaque, the 4 surfaces of the teeth included in the study (mesial, distal, vestibule, lingual) (0= no swelling, 2= Moderate to severe gingival swelling, bleeding after air drying)

Time frame
Initial, 3 months, 6 months, 12 months
2

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) (0= no pain, 10=worst)

Time frame
Immediately postoperative
3

Child behaviour

Venham Anxiety Rating Scale (0= total cooperation, best possible working conditions, no crying or physical protest, 5= general protest, no cooperation, physical restraint is required)

Time frame
Intraoperative
4

Child anxiety

Venham Anxiety Rating Scale (0= relaxed, smiling, willing, and able to converse, 5= loud crying unable to listen to verbal communication)

Time frame
Intraoperative

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: