## Protocol Section
### Identification Module
**NCT ID:** NCT01726179

**Brief Title:** Efficacy of Proximal Caries Infiltration

**Official Title:** Efficacy of Resin Infiltration of Proximal Caries Lesions in Primary Molars: Randomized Clinical Trial

#### Organization Study ID Info
**ID:** ECIPRJ13
#### Organization
**Class:** INDUSTRY
**Full Name:** DMG Dental Material Gesellschaft mbH
### Status Module
#### Completion Date
**Date:** 2018-12

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-04-26

**Type:** ACTUAL

**Last Update Submit Date:** 2022-04-19

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2017-12

**Type:** ACTUAL

#### Start Date
**Date:** 2013-12

**Type:** ACTUAL

**Status Verified Date:** 2022-04

#### Study First Post Date
**Date:** 2012-11-14
**Type:** ESTIMATED
**Study First Submit Date:** 2012-11-01
**Study First Submit QC Date:** 2012-11-09
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Universidade Federal do Rio de Janeiro

**Class:** OTHER_GOV

**Name:** Rio de Janeiro State Research Supporting Foundation (FAPERJ)

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** DMG Dental Material Gesellschaft mbH

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The goal of the project is to investigate the clinical efficacy of management of early caries lesions by resin infiltration and to further scrutinize the patient stress experiences.

**Detailed Description:** The aim of this study is to test the clinical efficacy of caries infiltration to arrest proximal caries lesions in primary molars. It was hypothesized that infiltrated lesions (test lesions) will progress significantly less than non infiltrated lesions (control lesions). Additionally, it was hypothesized that dental anxiety and stress related to caries infiltration will be significantly less than dental anxiety related to a conventional restorative procedure. The study will be a controlled clinical trial with a split mouth design and blind evaluation of the outcome (caries progression). Caries progression will be evaluated annually, 12, 24, and 36 months after treatment.

### Conditions Module

**Conditions:**

- Dental Health

- Caries

**Keywords:**

- caries infiltration

- caries arrest

- dental anxiety

- dental stress

- resin infiltration

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 50

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** This study is a split mouth design. One tooth with a proximal caries lesion is randomized into this arm and another tooth to the arm "Control". Teeth in this arm are treated by the resin infiltration technique using Icon (DMG, Germany) according to manufactures´ instructions. In addition patients and their guardians are instructed to floss once a day and to brush with fluoridated toothpaste twice a day.

Digital bitewing radiographs will be taken at baseline and repeated after 12 months. Additionally caries risk will be evaluated.

**Intervention Names:**

- Device: Resin infiltration

**Label:** Resin infiltration

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** This study is a split mouth design. One tooth with a proximal caries lesion is randomized into this arm and another tooth to the arm "Resin infiltration". Teeth randomized into this arm do not recieve any special treatment except general oral nonivasiv treatment (flossing and brushing). Patients and their guardians are instructed to floss once a day and to brush with fluoridated toothpaste twice a day.

Digital bitewing radiographs will be taken at baseline and repeated after 12 months. Additionally caries risk will be evaluated.

**Intervention Names:**

- Device: Control

**Label:** Control

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Resin infiltration

**Description:** Proximal caries lesions that are selected for this intervention will be treated with the resin infiltrant Icon according to the manufacturer's instructions. In short, local anesthesia of the gingival papila, application of rubber dam, etching of the lesion surface for 120 s using 15%HCl gel, washing the lesion with water spray for 30 s, drying the lesion with 100% ethanol for 30 s and subsequent air blowing, application of the infiltrant for 180 s using an applicator provided with the kit, removing excess material from the lesion surface by air blowing and flossing, light curing of the infiltrant for 40 s, repeated application for 60 s, light curing for 40 s, polishing, and removal of the rubber dam.

**Name:** Resin infiltration

**Other Names:**

- Icon (DMG, Germany), Approximal resin infiltration kit

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Control

**Description:** Proximal caries lesions do not recieve a placebo treatment, but simply left untreated.

**Name:** Control

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Radiographic evaluation of infiltrated and control caries lesions to evaluate caries progression. This is done by pairwise comparison of digital bitewing radiographs by one calibrated, blinded examiner.

**Measure:** Caries progression rate

**Time Frame:** 1 year

#### Secondary Outcomes

**Description:** To evaluate dental anxiety and stress reactions in relation to the caries infiltration procedure in comparison with a dental examination appointment and conventional resin restoration appointment.

A facial image scale with five faces ranging from very happy (1) to very unhappy (5) will be used.

**Measure:** Stress reaction during treatment

**Time Frame:** Immediate

**Description:** Caries risk is asses based on caries index (Nyvad criteria), proximal plaque index (0 = no visible plaque; 1 = visible plaque) and gingival bleeding index (0 = no bleeding after flossing; 1 = bleeding after flossing), dietary habits, and exposition to fluorides based on the Cariogram model.

**Measure:** Caries risk

**Time Frame:** Baseline, 6 months, 1 year, 2 years, 3 years

**Description:** Radiographic evaluation of infiltrated and control caries lesions to evaluate caries progression in long term. This is done by pairwise comparison of digital bitewing radiographs by one calibrated, blinded examiner.

**Measure:** Caries progression rate

**Time Frame:** 2 years, 3 years

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* children with one tooth surface with active caries lesions
* two primary molars with proximal lesion detected on the x-ray (scores 2 (E2) or 3 (D1) in Mejàre et al. scoring system with less depth
* asigned informed consent.

Exclusion Criteria:

* children who do not cooperate during dental appointments
* primary molars supposed to exfoliate in less than two years
* lesions showing obvious cavitation or clear sings of inactivity

**Maximum Age:** 9 Years

**Minimum Age:** 5 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Rio de Janeiro

**Country:** Brazil

**Facility:** Universidade do Estado do Rio de Janeiro, Faculdade de Odontologia.

**Zip:** 20551-031

#### Overall Officials

**Official 1:**

**Affiliation:** Universidade do Estado do Rio de Janeiro, Faculdade de Odontologia

**Name:** Vera M Soviero, Prof., Dr.

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Ammari MM, Jorge RC, Souza IPR, Soviero VM. Efficacy of resin infiltration of proximal caries in primary molars: 1-year follow-up of a split-mouth randomized controlled clinical trial. Clin Oral Investig. 2018 Apr;22(3):1355-1362. doi: 10.1007/s00784-017-2227-7. Epub 2017 Oct 8.

**PMID:** 28990122

**Citation:** Jorge RC, Ammari MM, Soviero VM, Souza IPR. Randomized controlled clinical trial of resin infiltration in primary molars: 2 years follow-up. J Dent. 2019 Nov;90:103184. doi: 10.1016/j.jdent.2019.103184. Epub 2019 Aug 26.

**PMID:** 31465818

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC14

- Name: Heart and Blood Diseases

### Condition Browse Module - Browse Leaves

- ID: M4324

- Name: Anxiety Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M9411

- Name: Heart Arrest

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Infe

- Name: Anti-Infective Agents

### Intervention Browse Module - Browse Leaves

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M3777

- Name: Ethanol

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
