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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06591143
Enrollment
46
Registered
2024-09-19
Start date
2024-10-01
Completion date
2025-12-01
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Decayed Primary Molars

Keywords

Decayed primary molars ART Hall technique

Brief summary

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.

Interventions

PROCEDUREART

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

PROCEDUREHall technique

Stainless steel crown placement without tooth preparation

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
4 Years to 6 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Periodontal healthinitial, 3 months, 6 months, 12 monthsWhile 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

MeasureTime frameDescription
Gingival indexInitial, 3 months, 6 months, 12 monthsWhile 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)
Postoperative pain and discomfortImmediately postoperativeImmediately 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)
Child behaviourIntraoperativeVenham Anxiety Rating Scale (0= total cooperation, best possible working conditions, no crying or physical protest, 5= general protest, no cooperation, physical restraint is required)
Child anxietyIntraoperativeVenham Anxiety Rating Scale (0= relaxed, smiling, willing, and able to converse, 5= loud crying unable to listen to verbal communication)
Canine overbiteInitial, 3 months, 6 months, 12 monthsThe 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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026