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NCT Number: NCT06591143

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

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.

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Key information

Conditions

Decayed Primary Molars

Age range

4 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age: From 4 to 6 years.
  • Caries in primary molars within enamel/dentin with vital pulp.
  • Healthy children.
  • Cooperative children.

Exclusion criteria

  • Presence of signs and symptoms of necrosis.
  • Root caries.
  • History of Spontaneous pain.

Treatment and study plan

ART

Procedure

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

Hall technique

Procedure

Stainless steel crown placement without tooth preparation

Primary outcomes

  1. Periodontal health

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

    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)

Secondary outcomes

  1. Gingival index

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

    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)

  2. Postoperative pain and discomfort

    Time frame: Immediately postoperative

    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)

  3. Child behaviour

    Time frame: Intraoperative

    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)

  4. Child anxiety

    Time frame: Intraoperative

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

  5. Canine overbite

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

    The canine overbite will be calculated before the preparation by measuring the distance between the incisal points of the maxillary canine on the same side of the mouth to the gingival zenith of the mandibular canine using a Boley Gauge

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Evaluation Of Periodontal Health After Treatment With Hall Technique Compared to Atraumatic Restorative Treatment in The Management of Carious Primary Molars: A Randomized Clinical Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Sep 19, 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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