## Protocol Section
### Identification Module
**NCT ID:** NCT06412731

**Brief Title:** Comparing the Effectiveness of Papain Based Chemico-mechanical Caries Removal Gel and 38% Silver Diamine Fluoride for Treating Active Caries Lesion of Primary Molars

**Official Title:** Comparing the Effectiveness of Papain Based Chemico-mechanical Caries Removal Gel and 38% Silver Diamine Fluoride for Treating Active Caries Lesion of Primary Molars

#### Organization Study ID Info
**ID:** MUPRU004
#### Organization
**Class:** OTHER
**Full Name:** Al-Mustansiriyah University
### Status Module
#### Completion Date
**Date:** 2024-06-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-14

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-08

**Overall Status:** ACTIVE_NOT_RECRUITING

#### Primary Completion Date
**Date:** 2024-05-23

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-01-02

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-14
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-25
**Study First Submit QC Date:** 2024-05-08
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Al-Mustansiriyah University

#### Responsible Party

**Investigator Affiliation:** Al-Mustansiriyah University

**Investigator Full Name:** Alhamzah thaer hasan Ankaz

**Investigator Title:** BDS

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

### Description Module

**Brief Summary:** 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:

1. Arrestment of caries lesion and the emergence of a new one
2. Time required for the treatment
3. Adverse events
4. Children's anxiety

**Detailed Description:** 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:

1. Duration of treatment
2. (feeling of pain) and the need for anesthetic
3. Incidents with negative outcomes that have been officially documented
4. Filling material adhesiveness fellow up

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.

### Conditions Module

**Conditions:**

- Dental Caries in Children

**Keywords:**

- CMCR

- SDF

- Ceramic bur

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 45

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Cera bur (Ceramic Bur) Komet, Lemgo, Germany

**Intervention Names:**

- Other: Cera-bur

**Label:** Ceramic bur (Cerabur) C

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** e-SDF (SDF 38%) E-kids, India

**Intervention Names:**

- Other: E-SDF

**Label:** Silver Diamine Fluoride (e-SDF) S

**Type:** ACTIVE_COMPARATOR

#### Arm Group 3

**Description:** Brix3000 (Papain based gel) S.R.L., Argentina

**Intervention Names:**

- Other: Brix3000

**Label:** CMCR gel (Brix3000) B

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Ceramic bur (Cerabur) C

**Description:** Dental caries removal using a low-speed handpiece and a ceramic bur and restoring the cavity with Glass ionomer filling material

**Name:** Cera-bur

**Other Names:**

- Ceramic bur

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- CMCR gel (Brix3000) B

**Description:** Chemical-dissolving active dental caries and hand instrument used for removing the lesion then restoring with Glass ionomer filling material

**Name:** Brix3000

**Other Names:**

- Papain-based CMCR

**Type:** OTHER

#### Intervention 3

**Arm Group Labels:**

- Silver Diamine Fluoride (e-SDF) S

**Description:** Arresting the infected dentin and the demineralized lesion covered with Glass-ionomer filling

**Name:** E-SDF

**Other Names:**

- 38% Silver Diamine fluoride

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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

**Measure:** Adverse event

**Time Frame:** during the first two weeks

**Description:** 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

**Measure:** Filling fellow up

**Time Frame:** after 3 months

#### Secondary Outcomes

**Description:** 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

**Measure:** anxiety level

**Time Frame:** immediately after the procedure

**Description:** 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,

**Measure:** Time

**Time Frame:** This will take about from 5 to 30 minutes

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Each child should have primary molars with open carious lesions, either on the occlusal surface or Proximal one with the absence of a neighboring tooth.
* These lesions should affect the dentin but not expose the pulp.
* The depth of the cavities should measure between 40-99 using a DIAGNOdent caries detection instrument for standardization

Exclusion Criteria:

* Children were excluded if parents were unwilling to be assigned to any of the approaches
* Children that had any abnormal medical condition or silver or papain allergy
* Chose molars with clinical or radiographic signals of pulp involvement

**Healthy Volunteers:** True

**Maximum Age:** 8 Years

**Minimum Age:** 7 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Baghdad

**Country:** Iraq

**Facility:** College of Dentistry, Mustansiriyah University

**State:** Al-karkh

**Zip:** 10011

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** 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.

**PMID:** 35506381

**Citation:** 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.

**PMID:** 31279925

#### See Also Links

**Label:** Comparative Evaluation of 'Less Invasive Approach' of caries excavation and 'Only Arrest And No Excavation Approach' in dental caries management in primary molars- A Randomised Controlled Trial

**URL:** https://jamdsr.com/uploadfiles/17vol9issue8pp84-92.20210815050049.pdf

**Label:** Evaluation of the Efficacy of Caries Removal Using Papain Gel (Brix 3000) and Smart Preparation Bur(in vivo Comparative Study)

**URL:** https://global-ie.com/wp-content/uploads/2022/02/comparativo-brix-vs-fresas-inteligentes.pdf

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000017001

- Term: Tooth Demineralization

- ID: D000014076

- Term: Tooth Diseases

- ID: D000009057

- Term: Stomatognathic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC07

- Name: Mouth and Tooth Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M6928

- Name: Dental Caries

- Relevance: HIGH

- As Found: Dental Caries

- ID: M19339

- Name: Tooth Demineralization

- Relevance: LOW

- As Found: Unknown

- ID: M16831

- Name: Tooth Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12017

- Name: Stomatognathic Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003731

- Term: Dental Caries

### Intervention Browse Module - Ancestors

- ID: D000002327

- Term: Cariostatic Agents

- ID: D000020011

- Term: Protective Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Ot

- Name: Other Dietary Supplements

### Intervention Browse Module - Browse Leaves

- ID: M8587

- Name: Fluorides

- Relevance: HIGH

- As Found: Genetic

- ID: M21869

- Name: Protective Agents

- Relevance: LOW

- As Found: Unknown

- ID: T417

- Name: Papain

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000005459

- Term: Fluorides

### Misc Info Module

- Version Holder: 2024-05-31
