## Protocol Section
### Identification Module
**NCT ID:** NCT06432049

**Brief Title:** Endocrown Restoring First Permanent Molar in Children

**Official Title:** Clinical and Radiographic Outcome of Endocrown Restoring First Permanent Molar in Children: Clinical Randomized Study

#### Organization Study ID Info
**ID:** MKSU/22-11-4
#### Organization
**Class:** OTHER
**Full Name:** Kafrelsheikh University
### Status Module
#### Completion Date
**Date:** 2024-05-13

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-21

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-11-09

**Type:** ACTUAL

#### Start Date
**Date:** 2022-12-05

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Kafrelsheikh University

#### Responsible Party

**Investigator Affiliation:** Kafrelsheikh University

**Investigator Full Name:** Ahmed Ismail Taha

**Investigator Title:** lecturer

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** Clinical and radiographic evaluation of endodontically treated first permanent molars in thirty children restored with three different restorations over 12 months

**Detailed Description:** This study comprised 30 children, with age range of (10-13) years old, with endodontically treated first permanent molars. Participants were classified into three groups according to type and material of the final restoration. All selected children were assigned to either PMC group (n=10) restored with performed metal crowns (Stainless-steel Molar Crowns) , EMX group (n=10) endocrown fabricated from CAD-CAM lithium disilicate glass ceramic , COP group (n=10) endocrown fabricated from CAD-CAM reinforced composite. After cementation, all children were evaluated over one year; at one week post-operative, 6 and 12 months for the following criteria: radiographic findings, plaque index, periodontal index, parent satisfaction.

### Conditions Module

**Conditions:**

- Comparing Different Types of Restorations for Restoring Endodontically Treated Permanent First Molar in Children

**Keywords:**

- Endocrown

- CAD-CAM

- Children

- Ceramic

- Molars

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** FACTORIAL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 30

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** endodontically treated molar restored with Stainless steel crown

**Intervention Names:**

- Other: restoration for endodontically treated molar

**Label:** PMC

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** endodontically treated molar restored with endocrown fabricated from CAD-CAM lithium disillicate

**Intervention Names:**

- Other: restoration for endodontically treated molar

**Label:** EMX

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** endodontically treated molar restored with endocrown fabricated from CAD-CAM composite

**Intervention Names:**

- Other: restoration for endodontically treated molar

**Label:** COP

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- COP

- EMX

- PMC

**Description:** prefabricated stainless steel crown or endocrown

**Name:** restoration for endodontically treated molar

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** periodical radiograph was used to evaluate all 30 participants for recurrent caries or periapical pathologic findings

**Measure:** number of participants with pathological changes in radiographs

**Time Frame:** 6 months

**Description:** evaluation of the extent of parent satisfaction with different type of restorations using a special scale; Each reponse was scored as follows; (5) strongly agree, (4) agree (3) neutral, (2) disagree and (1) strongly disagree.

**Measure:** degree of parent satisfaction with different restorations

**Time Frame:** 6 month

**Description:** plaque index evaluate the plaque accumulation around different type of restorations. this index involves:

* Plaque index 0: No plaque is in the area adjacent to the gingiva.
* Plaque index 1: There is a plaque in the form of a thin film on the gingival margin.
* Plaque index 2: There is a visible plaque in the gingival pocket and gingival margin.
* Plaque index 3: There is a dense plaque in the gingival pocket and on the gingival margin.

**Measure:** rate of plaque accumulation on different type of restorations

**Time Frame:** 6 months

**Description:** gingival index was used to evaluate the gingival health surrounding restorationsThis index involves a scale from 0 to 3 for the buccal, lingual, mesial and distal surfaces that is scored as follows: 0 indicates healthy gums; 1 indicates slight color changes, light edema and no presence of bleeding on probing; 2 indicates edema with slight redness and bleeding on probing; and 3 indicates severe edema, redness, the presence of ulceration and a tendency for spontaneous bleeding.

**Measure:** effect of different restoration on surrounding gingiva

**Time Frame:** 6 months

#### Secondary Outcomes

**Description:** periodical radiograph was used to evaluate all 30 participants for recurrent caries or periapical pathologic findings

**Measure:** number of participants with pathological changes in radiographs

**Time Frame:** 1 year

**Description:** using a special scale; Each reponse was scored as follows; (5) strongly agree, (4) agree (3) neutral, (2) disagree and (1) strongly disagree.

**Measure:** degree of parent satisfaction with different restorations

**Time Frame:** 1 year

**Description:** plaque index evaluate the plaque accumulation around different type of restorations. this index involves:

* Plaque index 0: No plaque is in the area adjacent to the gingiva.
* Plaque index 1: There is a plaque in the form of a thin film on the gingival margin.
* Plaque index 2: There is a visible plaque in the gingival pocket and gingival margin.
* Plaque index 3: There is a dense plaque in the gingival pocket and on the gingival margin.

**Measure:** rate of plaque accumulation on different type of restorations

**Time Frame:** 1 year

**Description:** gingival index was used to evaluate the gingival health surrounding restorationsThis index involves a scale from 0 to 3 for the buccal, lingual, mesial and distal surfaces that is scored as follows: 0 indicates healthy gums; 1 indicates slight color changes, light edema and no presence of bleeding on probing; 2 indicates edema with slight redness and bleeding on probing; and 3 indicates severe edema, redness, the presence of ulceration and a tendency for spontaneous bleeding.

**Measure:** effect of different restoration on surrounding gingiva

**Time Frame:** 1 year

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patient age ranging from 10-13 years old with closed apex.
* Normal occlusion without any para-functional habits.
* Decayed lower first molar.
* Supra-gingival margin was required after preparation.
* Absence of root fractures or cracks.

Exclusion Criteria:

* Difficulty to apply rubber dam for proper endocrown bonding.
* Lack of patient cooperation for post-operative recall and follow up.
* Bad oral hygiene

**Maximum Age:** 13 Years

**Minimum Age:** 10 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Kafr Ash Shaykh

**Country:** Egypt

**Facility:** Kafr El Shaikh University

**Zip:** 6860404

### IPD Sharing Statement Module

**Description:** all data will be shared after publishing.

**IPD Sharing:** UNDECIDED

## Derived Section

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: PsychDr

- Name: Psychotropic Drugs

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M19022

- Name: Lithium Carbonate

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
