## Protocol Section
### Identification Module
**NCT ID:** NCT03670979

**Brief Title:** Periodontal Osseous Wall Piezosplitting and EDTA Root Surface Etching

**Official Title:** A Novel Approach of Periodontal Osseous Wall Piezosplitting and EDTA Root Surface Etching in Management of Localized Intrabony Defects With Wide Angulation. Controlled Clinical Trial

#### Organization Study ID Info
**ID:** 839/2757
#### Organization
**Class:** OTHER
**Full Name:** Al-Azhar University
### Status Module
#### Completion Date
**Date:** 2017-01-05

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-02-14

**Type:** ACTUAL

**Last Update Submit Date:** 2023-02-13

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2017-01-05

**Type:** ACTUAL

#### Start Date
**Date:** 2016-01-05

**Type:** ACTUAL

**Status Verified Date:** 2023-02

#### Study First Post Date
**Date:** 2018-09-14
**Type:** ACTUAL
**Study First Submit Date:** 2018-08-01
**Study First Submit QC Date:** 2018-09-12
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Al-Azhar University

#### Responsible Party

**Investigator Affiliation:** Al-Azhar University

**Investigator Full Name:** mahmoud eldestawy

**Investigator Title:** lecturer, periodontology department

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** This study was designed to investigate the use of minimally invasive Piezo knife to harvest vascularized interceptal bone pedicle in treating intrabony defects.

**Detailed Description:** Sixteen non-smoking patients with severe chronic periodontitis participated in this prospective, randomized clinical study. Patients were randomly assigned into one of a 2 groups (8 patients each): bone substitute grafting of the intrabony defect, control group (Gr1), intrabony defect osseous wall swaging (OWS) combined xenograft (Gr2). In both groups root surfaces where treated with a neutral 24% EDTA gel and saline irrigation. Clinical and radiographic measurements were reassessed at 6 months after surgery.

### Conditions Module

**Conditions:**

- Periodontitis

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 16

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** xenograft alone

**Intervention Names:**

- Procedure: bone swaging

**Label:** bone swaging alone

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** bone swaging with EDTA

**Intervention Names:**

- Procedure: bone swaging

**Label:** bone swaging plus EDTA

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- bone swaging alone

- bone swaging plus EDTA

**Description:** osseous wall pedicle was placed to treat the infrabony defect by autogrnous bone

**Name:** bone swaging

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** removing the defect as seen in radiograph defect filling with bone swaging with edta and bone substitute

**Measure:** Radiographic evaluation

**Time Frame:** 3 months

#### Secondary Outcomes

**Description:** By periodontal prob to measure the clinical parameter

**Measure:** Clinical pocket depth

**Time Frame:** 3month

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. good compliance with plaque control instructions following initial therapy
2. teeth involved were all vital with no mobility ;
3. each subject contributed a single predominately 2 or 3-wall intrabony interproximal defect around premolar or molar teeth without furcation involvement;

Exclusion Criteria:

1. no systemic diseases which could influence the outcome of therapy;
2. absence of periodontal treatment during the previous year.

**Maximum Age:** 60 Years

**Minimum Age:** 25 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Overall Officials

**Official 1:**

**Affiliation:** Ain Shams University

**Name:** ahmed y gamal, professor

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**Description:** institutional review board, egypt

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010510

- Term: Periodontal Diseases

- ID: D000009059

- Term: Mouth 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: M13427

- Name: Periodontitis

- Relevance: HIGH

- As Found: Periodontitis

- ID: M13419

- Name: Periodontal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12019

- Name: Mouth Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12017

- Name: Stomatognathic Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010518

- Term: Periodontitis

### Misc Info Module

- Version Holder: 2024-05-24
