Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2025-12-30 @ 3:04 AM
Study NCT ID:
NCT06924203
Status:
COMPLETED
Last Update Posted:
2025-04-11
First Post:
2024-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between Amalgam and Hall Technique in Treatment of Carious Primary Teeth
Sponsor:
Suez Canal University
Organization:
Study Overview
Official Title:
Comparison Between Amalgam Restoration and Hall Technique in Treatment of Carious Primary Molars
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
(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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: