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

NCT06924203 | Completed DMC

• 1 other identifier: REC 185/2019
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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

Conditions

Dental Caries in Children

Keywords

Caries; Hall technique; Amalgam; Primary molars

Outcome Measures

Primary Outcomes (6)

• 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; 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.

  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: 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.

  12 months

Study Arms (2)

Amalgam group

EXPERIMENTAL

Carious primary molars will be restored using amalgam (code 4 or 5)

Procedure: AmaIgam

Hall Technique Group

EXPERIMENTAL

Carious primary molars will be restored using stainless steel crowns (Hall Technique).

Procedure: Stainless steel

Interventions

AmaIgam PROCEDURE

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

Also known as: AmaIgam group

Amalgam group

Stainless steel PROCEDURE

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

Also known as: Hall Technique

Hall Technique Group

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suez Canal University: lead
• Suez canal university hospitals: collaborator

Study Sites (1)

Suez Canal University، Faculty of Dentistry

Ismailia, Ismailia Governorate, 41522, Egypt

Location

Related Publications (1)

• 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.

  PMID: 24683915 BACKGROUND

MeSH Terms

Interventions

Stainless Steel

Intervention Hierarchy (Ancestors)

Steel; Iron Compounds; Inorganic Chemicals; Alloys; Metals; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Mohamed S Farag, Professor

  Suez Canal University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Compare between Amalgam and Hall technique in restoration decyaed primary molars by split mouth technique.. acceptability of Hall technique for care givers and children..
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: April 11, 2025
• Study Start: December 18, 2019
• Primary Completion: February 27, 2023
• Study Completion: February 22, 2024
• Last Updated: April 11, 2025

Record last verified: 2024-07

Locations

EG (1)