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

Not Applicable

Completed

• Conditions: Dental Caries in Children

• Registration Number: NCT06924203
• Lead Sponsor: Suez Canal University

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.

Study Timeline

• Study Start: 2019-12-18
• Primary Completion: 2023-02-27
• Study Completion: 2024-02-22
• Status Verified: 2024-07
• Study First Submitted: 2024-07-11
• Study First Submitted QC: 2025-04-04
• Last Update Submitted: 2025-04-04
• Study First Posted: 2025-04-11
• Last Update Posted: 2025-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Restoration efficiency	3 months	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).
Pain score	12 months	Pain scores were evaluated VAS pain 10-score scale
Swelling	12 months	Swelling scores
Tooth mobility evaluation	12 months	Tooth mobility evaluation; Tooth mobiIity wiII be graded cIinicaIIy by Grace \& SmaIes mobiIity index.
Gingival index	12 months	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.
Radiographic examination	12 months	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.

Trial Locations

Locations (1)

Suez Canal University، Faculty of Dentistry; 🇪🇬 Ismailia, Egypt