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

NCT ID: NCT06924203

Last Updated: 2025-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-18
• Study Completion Date: 2024-02-22

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.

Conditions

Dental Caries in Children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hall Technique Group

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

Group Type: EXPERIMENTAL

Stainless steel

Intervention Type: PROCEDURE

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

Amalgam group

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

Group Type: EXPERIMENTAL

AmaIgam

Intervention Type: PROCEDURE

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

Interventions

AmaIgam

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

Intervention Type: PROCEDURE

Stainless steel

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

Intervention Type: PROCEDURE

Other Intervention Names

AmaIgam group; Hall Technique

Eligibility Criteria

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.

-

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suez canal university hospitals

UNKNOWN

Sponsor Role: collaborator

Suez Canal University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mohamed S Farag, Professor

Role: STUDY_CHAIR

Suez Canal University

Locations

Suez Canal University، Faculty of Dentistry

Ismailia, Ismailia Governorate, Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 24683915 (View on PubMed)

Other Identifiers

REC 185/2019

Identifier Type: -

Identifier Source: org_study_id