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Dental Caries in ChildrenNCT06924203

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

A study testing AmaIgam and Stainless steel in people with Dental Caries in Children, run by Suez Canal University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 3 to 5 years
Conditions the study is for
Dental Caries in Children
What is being tested?
AmaIgam and Stainless steel
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteEgypt
Study dates
18 Dec 2019to 22 Feb 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 5 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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).

Who cannot join

  • 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.
  • -

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Suez Canal University، Faculty of Dentistry

    Ismailia, Ismailia Governorate, 41522

Other trials in Egypt

About this study

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

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

Read the 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.

Being tested
AmaIgam, Stainless steel
Keywords
Caries, Hall technique, Amalgam, Primary molars

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AmaIgamProcedure or surgery

    Also called AmaIgam group

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

  • Stainless steelProcedure or surgery

    Also called Hall Technique

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

Study groups in NCT06924203
Study groupRoleWhat they receive
Amalgam groupExperimentalCarious primary molars will be restored using amalgam (code 4 or 5)
Receives: Procedure: AmaIgam
Hall Technique GroupExperimentalCarious primary molars will be restored using stainless steel crowns (Hall Technique).
Receives: Procedure: Stainless steel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain score

    Pain scores were evaluated VAS pain 10-score scale

    Measured: 12 months

  2. Swelling

    Swelling scores

    Measured: 12 months

  3. Tooth mobility evaluation

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

    Measured: 12 months

  4. Restoration efficiency

    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).

    Measured: 3 months

  5. Gingival index

    The 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.

    Measured: 12 months

  6. Radiographic examination

    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.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2025
  2. Study start18 Dec 2019
  3. Primary completion27 Feb 2023
  4. Study completion22 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Active Comparator:Amalgam group for decayed primary molars Experimental: Hall technique for restore decayed primary molars split mouth technique.
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06924203
Sponsor's protocol ID
REC 185/2019
Status last verified
Jul 2024
First submitted
11 Jul 2024
Last updated
11 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 24683915

Questions about this trial

What is this clinical trial studying?

A study testing AmaIgam and Stainless steel in people with Dental Caries in Children, run by Suez Canal University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain score (time frame: 12 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06924203, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2025.

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