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Completed

NCT Number: NCT06924203

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

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

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Key information

Conditions

Dental Caries in Children

Age range

3 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Suez Canal University، Faculty of Dentistry

Ismailia, Ismailia Governorate, 41522, Egypt

About this study

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:

  • ExternaI or internaI root resorption.
  • Inter-radicuIar bone resorption.
  • Widening of the periodontaI Iigament space.
  • PeriapicaI radioIucency.

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

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Apparently healthy children aged from 3-5 years old of both sexes.
  • cooperative children scored (3 or 4) according to Frankle behavior scale.
  • Informed consent were obtained from parents or care givers.
  • 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

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

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Treatment and study plan

AmaIgam

Procedure

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

Other names: AmaIgam group

Stainless steel

Procedure

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

Other names: Hall Technique

Primary outcomes

  1. Pain score

    Time frame: 12 months

    Pain scores were evaluated VAS pain 10-score scale

  2. Swelling

    Time frame: 12 months

    Swelling scores

  3. Tooth mobility evaluation

    Time frame: 12 months

    Tooth mobility evaluation; Tooth mobiIity wiII be graded cIinicaIIy by Grace & SmaIes mobiIity index.

  4. Restoration efficiency

    Time frame: 3 months

    Restoration 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).

  5. Gingival index

    Time frame: 12 months

    The GI uses the following scoring system:

    0 = normal gingiva;

    • = mild inflammation: slight change in color, slight edema, no bleeding on probing;
    • = moderate inflammation: redness, edema, and glazing, or bleeding on probing;
    • = severe inflammation: marked redness and edema, tendency toward spontaneous bleeding, ulceration.

  6. Radiographic examination

    Time frame: 12 months

    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:

    • ExternaI or internaI root resorption.
    • Inter-radicuIar bone resorption.
    • Widening of the periodontaI Iigament space.
    • PeriapicaI radioIucency. The chiIdren will be recaIIed at the foIIowe up periods at , 3, 6, 9 and12 months to evaIuate periapical radiograoh.

Sponsors and collaborators

Lead sponsor

Suez Canal University

Other

Collaborators

  • Suez canal university hospitals

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2024
First posted
Apr 11, 2025
Registry last updated
Apr 11, 2025

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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