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This study aims to investigate the efficacy of silver diamine fluoride (SDF) and Papain-based chemico-mechanical caries removal gel and using ceramic bur as a control in treating dentine caries in primary molars aged 7-8 years children. by investigating the following outcomes:
The traditional approach to removing caries with dental burs is the most often used technique in the treatment of dental caries. However, this method is continuously associated with many disadvantages, such as patients finding drilling uncomfortable, the frequent need for local anesthetic, and detrimental heat effects on the pulp.
The purpose of this research was to evaluate three minimally invasive therapies via the assessment of:
The null hypothesis was that there was no difference among Silver Diamine Fluoride, Brix3000 Papain based Chemico-mechanical caries removal product, and ceramic burr in time, anxiety, and pain, reported side effect
Randomized control clinical trial will be allocated into 3 groups: S group (treatment with SDF), B group (treatment with Brix3000 Papain based gel), and C group as control (treatment by rotary handpiece Smart bur)
Setting:
Sample collection: the samples are to be collected at The College of Dentistry, Al-Mustansiriyah University - Iraq- Baghdad Subject The sample size will be 45 children aged 7-8 years with primary molars with occlusal active caries lesions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ceramic bur (Cerabur) C | Active Comparator | Cera bur (Ceramic Bur) Komet, Lemgo, Germany |
|
| Silver Diamine Fluoride (e-SDF) S | Active Comparator | e-SDF (SDF 38%) E-kids, India |
|
| CMCR gel (Brix3000) B | Active Comparator | Brix3000 (Papain based gel) S.R.L., Argentina |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cera-bur | Other | Dental caries removal using a low-speed handpiece and a ceramic bur and restoring the cavity with Glass ionomer filling material |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse event | The following adverse events will be investigated: Pain, sensitivity, tooth discoloration, burning in the mouth, allergy altered taste of food, irritation of the gums or mucosa | during the first two weeks |
| Filling fellow up | The evaluation was done using the community periodontal index (CPI)-probe (WHO-probe) and a dental mirror. The treated lesions were classified according to the evaluation scores which were modified from those used by Francis et al.: score 1 - the restoration intact, covering all pits and fissures; score 2 - the restoration partially lost, the tooth is sound (no active/soft caries); score 3 - the restoration partially lost, the tooth is carious(active/soft caries); score 4 - the restoration completely lost, the tooth is sound; and score 5 - the restoration completely lost, the tooth is carious. The tooth was considered sound if its surface felt hard and shiny | after 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| anxiety level | Anxiety level prescribed by the patient using a facial image scale to measure the children' anxiety. Each kid was instructed to indicate the facial expression that most accurately conveyed their current emotional state, which may be categorized as either (very happy; happy; neutral; unhappy; or very unhappy | immediately after the procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| College of Dentistry, Mustansiriyah University | Baghdad | Al-karkh | 10011 | Iraq |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35506381 | Result | Satyarup D, Mohanty S, Nagarajappa R, Mahapatra I, Dalai RP. Comparison of the effectiveness of 38% silver diamine fluoride and atraumatic restorative treatment for treating dental caries in a school setting: A randomized clinical trial. Dent Med Probl. 2022 Apr-Jun;59(2):217-223. doi: 10.17219/dmp/143547. | |
| 31279925 | Result |
| Label | URL |
|---|---|
| Evaluation of the Efficacy of Caries Removal Using Papain Gel (Brix 3000) and Smart Preparation Bur(in vivo Comparative Study) | View source |
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|
| Brix3000 | Other | Chemical-dissolving active dental caries and hand instrument used for removing the lesion then restoring with Glass ionomer filling material |
|
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| E-SDF | Other | Arresting the infected dentin and the demineralized lesion covered with Glass-ionomer filling |
|
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| Time | the time required for the treatment in each group using a digital timer A digital timer which triggers as soon as the tooth brushing starts. During the first appointment starting from dental caries removal until sound dentin reached before Glass ionomer filling placement, | This will take about from 5 to 30 minutes |
| Vollu AL, Rodrigues GF, Rougemount Teixeira RV, Cruz LR, Dos Santos Massa G, de Lima Moreira JP, Luiz RR, Barja-Fidalgo F, Fonseca-Goncalves A. Efficacy of 30% silver diamine fluoride compared to atraumatic restorative treatment on dentine caries arrestment in primary molars of preschool children: A 12-months parallel randomized controlled clinical trial. J Dent. 2019 Sep;88:103165. doi: 10.1016/j.jdent.2019.07.003. Epub 2019 Jul 4. |
| ID | Term |
|---|---|
| C024633 | silver diamine fluoride |
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