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Comparison Between Amalgam and Hall Technique in Treatment of Carious Primary Teeth

Comparison Between Amalgam Restoration and Hall Technique in Treatment of Carious Primary Molars

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06924203
Enrollment
33
Registered
2025-04-11
Start date
2019-12-18
Completion date
2024-02-22
Last updated
2025-04-11

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

Conditions

Dental Caries in Children

Keywords

Caries, Hall technique, Amalgam, Primary molars

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.

Interventions

PROCEDUREAmaIgam

(AmaIgam group): 30 carious moIars, wiII be restored with (amaIgam).

A pre-formed stainless steel crown will be cemented over the carious molar without extensive tooth preparation or caries removal.

Sponsors

Suez canal university hospitals
CollaboratorUNKNOWN
Suez Canal University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

Compare between Amalgam and Hall technique in restoration decyaed primary molars by split mouth technique.. acceptability of Hall technique for care givers and children..

Intervention model description

Active Comparator:Amalgam group for decayed primary molars Experimental: Hall technique for restore decayed primary molars split mouth technique.

Eligibility

Sex/Gender
ALL
Age
3 Years to 5 Years
Healthy volunteers
No

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. \-

Design outcomes

Primary

MeasureTime frameDescription
Pain score12 monthsPain scores were evaluated VAS pain 10-score scale
Swelling12 monthsSwelling scores
Tooth mobility evaluation12 monthsTooth mobility evaluation; Tooth mobiIity wiII be graded cIinicaIIy by Grace & SmaIes mobiIity index.
Restoration efficiency3 monthsRestoration efficiency; Grase & SmaIis MobiIity Index Grade 0: 0.25 (physioIogic tooth mobiIity). Grade 1: 1 mm (HorizontaI mobiIity). Grade 2: 2 mm (HorizontaI mobiIity). Grade 3: 2 mm (HorizontaI and verticaI mobiIity).
Gingival index12 monthsThe GI uses the following scoring system: 0 = normal gingiva; 1. = mild inflammation: slight change in color, slight edema, no bleeding on probing; 2. = moderate inflammation: redness, edema, and glazing, or bleeding on probing; 3. = severe inflammation: marked redness and edema, tendency toward spontaneous bleeding, ulceration.
Radiographic examination12 monthsThe 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.

Countries

Egypt

Outcome results

None listed

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