Clinical trial NCT06924203: Comparison Between Amalgam and Hall Technique in Treatment of Carious Primary Teeth
Official title: Comparison Between Amalgam Restoration and Hall Technique in Treatment of Carious Primary Molars
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries in Children
Keywords: Caries
Hall technique
Amalgam
Primary molars
Lead sponsor: Suez Canal University
Sponsor class: OTHER
Collaborators: name: Suez canal university hospitals
First posted: 2025-04-11
Enrollment: 33
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Active Comparator:Amalgam group for decayed primary molars Experimental: Hall technique for restore decayed primary molars split mouth technique.
Primary purpose: TREATMENT

Brief summary: compare between amalgam restoration and hall technique for treatment of decayed primary molars and intervention treatment for decayed primary molars in children, age 3-5 years using split mouth technique in the same child, conventional amalgam restoration and use Stainless steel crown in other side

Detailed description: This study wiII be conducted on 30 chiIdren: The moIars wiII be treated by spIit mouth technique.

(AmaIgam group): 30 carious moIars, wiII be restored with (amaIgam) code 4 or 5 (16).

( StainIess steeI crowns group): 30 carious moIars wiII be restored with ((HaII Tech).

- CIinicaI Assessment:

During follow up periods if:

* Pain
* redness, and
* sweIIing wiII be assessed for presence or absence(18).
* Tooth mobiIity wiII be graded cIinicaIIy by Grace \& SmaIes mobiIity index(19).
* Restoration effecincy.
* Gingival index Gingival index (GI)

Radiographic examination ( Parallel PeriapicaI Radiograph) :

The radiographs will taken using the Parallel Periapical Technique, will be taken immediately on the first visit post operatively, to act as base line for radiographic evaluation.

The following criteria of radiographic assessment will include:

1. ExternaI or internaI root resorption.
2. Inter-radicuIar bone resorption.
3. Widening of the periodontaI Iigament space.
4. PeriapicaI radioIucency.

The chiIdren will be recaIIed at the foIIowe up periods at , 3, 6, 9 and12 months to evaIuate periapical radiograoh.

Eligibility criteria: Inclusion Criteria:

1. Apparently healthy children aged from 3-5 years old of both sexes.
2. cooperative children scored (3 or 4) according to Frankle behavior scale.
3. Informed consent were obtained from parents or care givers.
4. Children had bilateral carious primary molars were scored code 4 or code 5 according to (I.C.D.A.S.C) international caries restorable and evaluation method (split mouth tech).

Exclusion Criteria:

1. Clinical history of spontaneous pain, intra-oral or facial swelling or presence of fistula or sinus tract.
2. Radiographic findings of root resorption, pulp stone, furcation involvement or periapical pathosis as revealed by preoperative periapical radiography.
3. Patients who have any history of hypersensitivity to any of the materials to be used.
4. Parents/children who are uncooperative or refused to participate in the study.

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Primary outcomes:
measure: Pain score
timeFrame: 12 months
measure: Swelling
timeFrame: 12 months
measure: Tooth mobility evaluation
timeFrame: 12 months
measure: Restoration efficiency
timeFrame: 3 months
measure: Gingival index
timeFrame: 12 months
measure: Radiographic examination
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ismailia
country: Egypt
facility: Suez Canal University، Faculty of Dentistry
Study officials:
affiliation: Suez Canal University
name: Mohamed S Farag, Professor
role: STUDY_CHAIR
References:
citation: Page LA, Boyd DH, Davidson SE, McKay SK, Thomson WM, Innes NP. Acceptability of the Hall Technique to parents and children. N Z Dent J. 2014 Mar;110(1):12-7.