Comparison Between Amalgam Restoration and Hall Technique in Treatment of Carious Primary Molars
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Suez Canal University
- Enrollment
- 33
- Locations
- 2
- Primary Endpoint
- Restoration efficiency
Study Overview
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
Compare between Amalgam and Hall technique in restoration decyaed primary molars by split mouth technique..
acceptability of Hall technique for care givers and children..
Eligibility Criteria
- Ages
- 3 Years to 5 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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).
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Restoration efficiency
Time Frame: 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).
Swelling
Time Frame: 12 months
Swelling scores
Pain score
Time Frame: 12 months
Pain scores were evaluated VAS pain 10-score scale
Tooth mobility evaluation
Time Frame: 12 months
Tooth mobility evaluation; Tooth mobiIity wiII be graded cIinicaIIy by Grace \& SmaIes mobiIity index.
Gingival index
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported