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

S

Suez Canal University

Status

Completed

Conditions

Dental Caries in Children

Treatments

Procedure: Stainless steel
Procedure: AmaIgam

Study type

Interventional

Funder types

Other

Identifiers

NCT06924203
REC 185/2019

Details and patient eligibility

About

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

Full 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.

Enrollment

33 patients

Sex

All

Ages

3 to 5 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

33 participants in 2 patient groups

Amalgam group
Experimental group
Description:
Carious primary molars will be restored using amalgam (code 4 or 5)
Treatment:
Procedure: AmaIgam
Hall Technique Group
Experimental group
Description:
Carious primary molars will be restored using stainless steel crowns (Hall Technique).
Treatment:
Procedure: Stainless steel

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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