## Protocol Section
### Identification Module
**NCT ID:** NCT04825379

**Brief Title:** Clinical Evaluation of a Bioactive Material

**Official Title:** Clinical Evaluation of a Bioactive Material

#### Organization Study ID Info
**ID:** bioactive-composite
#### Organization
**Class:** OTHER
**Full Name:** Hacettepe University
### Status Module
#### Completion Date
**Date:** 2024-09-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-10-03

**Type:** ACTUAL

**Last Update Submit Date:** 2023-10-02

**Overall Status:** ACTIVE_NOT_RECRUITING

#### Primary Completion Date
**Date:** 2021-09-01

**Type:** ACTUAL

#### Start Date
**Date:** 2021-06-01

**Type:** ACTUAL

**Status Verified Date:** 2023-10

#### Study First Post Date
**Date:** 2021-04-01
**Type:** ACTUAL
**Study First Submit Date:** 2021-03-28
**Study First Submit QC Date:** 2021-03-28
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Hacettepe University

#### Responsible Party

**Investigator Affiliation:** Hacettepe University

**Investigator Full Name:** Dr. Fatma Dilşad Öz

**Investigator Title:** Assoc. Prof. Dr.

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The clinical performance of a bioactive composite and a posterior resin composite in class II restorations will be evaluated and compared. After recruiting participants with at least 2 approximal caries lesions, all restorations will be placed by a single clinician. All caries lesions will be removed before restoring. Cavities will be divided into two groups: a bioactive composite \[Cention N, Ivoclar Vivadent, Schaan, Liechtenstein (CN)\] and a posterior resin composite \[G-ænial Posterior (GC, Tokyo, Japan) (GP)\] All restorative procedures will be conducted according to manufacturers' instructions. Restorations will be scored using FDI criteria after a week (baseline) 6, 12, 24, 36 and 48 months. Descriptive statistics will be performed using chi-square tests.

### Conditions Module

**Conditions:**

- Tooth Disease

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 31

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Cention N, Ivoclar Vivadent, Schaan, Liechtenstein (CN)

**Intervention Names:**

- Device: bioactive composite

**Label:** bioactive composite

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** G-ænial Posterior (GC, Tokyo, Japan) (GP)

**Intervention Names:**

- Device: posterior composite

**Label:** posterior resin composite

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- bioactive composite

**Description:** Cention N

**Name:** bioactive composite

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- posterior resin composite

**Description:** G-ænial Posterior

**Name:** posterior composite

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Two year results according to FDI criteria

**Measure:** Clinical performances of different restorative systems according to FDI criteria

**Time Frame:** two years

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* age range will be 18 to 65
* patients should have at least 2 approximal caries lesions require restoration
* healthy periodontal status
* a good likelihood of recall availability

Exclusion Criteria:

* poor gingival health
* adverse medical history
* potential behavioral problems

**Healthy Volunteers:** True

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Ankara

**Country:** Turkey

**Facility:** Hacettepe University

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- 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: M16831

- Name: Tooth Diseases

- Relevance: HIGH

- As Found: Tooth Disease

- ID: M12017

- Name: Stomatognathic Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000014076

- Term: Tooth Diseases

### Misc Info Module

- Version Holder: 2024-05-24
