Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Aims: Evaluation of treatment success on HSPM-affected molars after ART and Hall technique.
comparison of pain during treatment with ART and Hall technique in HSPM. comparison of child and parent satisfaction with restorations used by ART and Hall technique.
Design: A randomized, controlled, crossover clinical study including thirty children.
Background and Aims:
Despite the widespread prevalence of HSPM:
there are no comparative studies yet between ART and Hall technique in the restoration of HSPM.
there are no studies yet on the success of ART in the treatment of HSPM.
Design:
A randomized, controlled, crossover clinical study including thirty children Each child will apply both of ART and Hall technique to him.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A (Hall Technique) | Active Comparator | 31 child will be treated by one performed metal crown using Hall technique on one of HSPM affected tooth. The correct size of SSC for tooth will be selected. Use the separating rubber if necessary. Dried the tooth and cemented the SSC by glass ionomer luting cement and used finger pressure to seat the crown and instructed the child to bite down on the SSC. Half of the total number of children will received performed metal crown at the first by divided them randomly to the two groups using the randomization table. |
|
| B (ART) | Experimental | 31 child will be treated by Bulk fill glass hybrid restorative system (Equia Forte HT®) using Atraumatic restoration treatment on one of HSPM affected tooth. Isolate the tooth by cotton rolls, remove the carious soft tissue using hand instrument excavators then condition the cavity with a polyacrylic acid solution 11.5% for 10 seconds. After washed and dried the cavity insert the GIC and protect it by Equia forte coat. Half of the total number of children will received ART at the first by divided them randomly to the two groups using the randomization table. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hall technique | Combination Product | The child will be placed to them SSC on one of their HSPM affected teeth. Pain during treatment will be assessed using the FLACC scale and satisfaction the child and parent will be evaluated using likert scale after the treatment immediately and after one month and evaluate the success restoration adapted from Innes et al. after 3_6_9_12 month. |
| Measure | Description | Time Frame |
|---|---|---|
| Dental pain assessed by FLACC scale | Evaluated by outcome assessor using the faces, legs, activity, cry, consolability behavioral rating scale (FLACC scale) a behavioral pain assessment scale which has five criteria face, legs, activity, cry, consolability, which are each assigned a score of 0,1 or2. Total score of scale is summed in range 0 to10, where:0=relaxed and comfortable; 1-3=mild discomfort; 4-6=moderate pain; 7-10=severe pain. | During the placement of the restoration |
| Measure | Description | Time Frame |
|---|---|---|
| Child Satisfaction with the restoration assessed by the Likert scale | Self-assessment by the children using Likert scale which is a psychometric scale has five responses (very satisfied, satisfied, neutral, unsatisfied, very unsatisfied) | Immediately after the placement of the restoration |
| Parent Satisfaction with the restoration assessed by the Likert scale |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical success of restoration assessed by evaluation criteria for restoration assessments after 3 months | Evaluated by outcome assessor using evaluation criteria for restoration assessments which has three scores (success, minor failures, major failures) for ART and Hall technique. | After 3 months from treatment |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nabih Raslan, Dr | Contact | 00963999140762 | Raslan.nabih@tishreen.edu.sy | |
| Aya Adl, Dr | Contact | 00963965334652 | Ayoosh.sy994@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Nabih Raslan, Dr | Tishreen University | Study Chair |
| Aya Adl, Dr | Tishreen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tishreen University | Recruiting | Latakia | Syria |
Up to date, there is no decision about IPD sharing
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000094603 | Dental Enamel Hypomineralization |
| ID | Term |
|---|---|
| D000094602 | Developmental Defects of Enamel |
| D014071 | Tooth Abnormalities |
| D018640 | Stomatognathic System Abnormalities |
| D009057 | Stomatognathic Diseases |
Not provided
Not provided
A randomized, controlled, crossover clinical study, comparison of ART and Hall Technique.
Not provided
Not provided
Not provided
Not provided
|
|
| ART | Combination Product | The child will be restored to them one of their HSPM affected teeth by GIC. Pain during treatment will be assessed using the FLACC scale and satisfaction the child and parent will be evaluated using likert scale after the treatment immediately and after one month and evaluate the success restoration adapted from Innes et al. after 3_6_9_12 month. |
|
|
Self-assessment by the parent using Likert scale which is a psychometric scale has five responses (very satisfied, satisfied, neutral, unsatisfied, very unsatisfied) |
| Immediately after the placement of the restoration after asking the child |
| Child Satisfaction with the restoration assessed by the Likert scale | Self-assessment by the children using Likert scale which is a psychometric scale has five responses (very satisfied, satisfied, neutral, unsatisfied, very unsatisfied) | After one month from treatment |
| Parent Satisfaction with the restoration assessed by the Likert scale | Self-assessment by the parent using Likert scale which is a psychometric scale has a five responses (very satisfied, satisfied, neutral, unsatisfied, very unsatisfied) | After one month from treatment after asking the child |
| Radiological success of restoration assessed by Radiological success cireteria after 6 months |
Evaluated by outcome assessor using Radiological success cireteria for restoration. where the case is considered successful radiologically when all signs of pulpal necrosis are absent. |
| After 6 months from traetment |
| Clinical success of restoration assessed by evaluation criteria for restoration assessments after 6 months | Evaluated by outcome assessor using evaluation criteria for restoration assessments which has three scores (success, minor failures, major failures) for ART and Hall technique. | After 6 months from treatment |
| Clinical success of restoration assessed by evaluation criteria for restoration assessments after 9 months | Evaluated by outcome assessor using evaluation criteria for restoration assessments which has three scores (success, minor failures, major failures) for ART and Hall technique. | After 9 months from treatment |
| Clinical success of restoration assessed by evaluation criteria for restoration assessments after 12 months | Evaluated by outcome assessor using evaluation criteria for restoration assessments which has three scores (success, minor failures, major failures) for ART and Hall technique. | After 12 months from treatment |
| Radiological success of restoration assessed by Radiological success cireteria after 12 months | Evaluated by outcome assessor using Radiological success cireteria for restoration. where the case is considered successful radiologically when all signs of pulpal necrosis are absent. | After 12 months from treatment |
| D014076 | Tooth Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |