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

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

Study Overview

• Status: Completed
• Conditions: Dental Caries in Children
• Intervention / Treatment: Procedure: AmaIgam; Procedure: Stainless steel

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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Ismailia, Egypt, 41522
    • Suez Canal University، Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Amalgam group; Carious primary molars will be restored using amalgam (code 4 or 5)	Procedure: AmaIgam; (AmaIgam group): 30 carious moIars, wiII be restored with (amaIgam).; Other Names: AmaIgam group
Experimental: Hall Technique Group; Carious primary molars will be restored using stainless steel crowns (Hall Technique).	Procedure: Stainless steel; A pre-formed stainless steel crown will be cemented over the carious molar without extensive tooth preparation or caries removal.; Other Names: Hall Technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score	Pain scores were evaluated VAS pain 10-score scale	12 months
Swelling	Swelling scores	12 months
Tooth mobility evaluation	Tooth mobility evaluation; Tooth mobiIity wiII be graded cIinicaIIy by Grace & SmaIes mobiIity index.	12 months
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).	3 months
Gingival index	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.	12 months
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: 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.	12 months

Collaborators and Investigators

• Sponsor: Suez Canal University
• Collaborators: Suez canal university hospitals
• Investigators: Study Chair: Mohamed S Farag, Professor, Faculty of Dentistry Suez Canal University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2019
• Primary Completion (Actual): February 27, 2023
• Study Completion (Actual): February 22, 2024

Study Registration Dates

• First Submitted: July 11, 2024
• First Submitted That Met QC Criteria: April 4, 2025
• First Posted (Actual): April 11, 2025

Study Record Updates

• Last Update Posted (Actual): April 11, 2025
• Last Update Submitted That Met QC Criteria: April 4, 2025
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Primary molars; Amalgam; Caries; Hall technique
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Demineralization; Dental Caries
• Other Study ID Numbers: REC 185/2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No