## Protocol Section
### Identification Module
**NCT ID:** NCT06426719

**Brief Title:** Efficiency of Using Osseodensification Protocol

**Official Title:** Efficiency of Using Osseodensification Protocol for Alveolar Ridge Expansion in Edentulous Alveolar Ridges

#### Organization Study ID Info
**ID:** 28908210103756
#### Organization
**Class:** OTHER
**Full Name:** Cairo University
### Status Module
#### Completion Date
**Date:** 2024-02-15

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-18

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2024-01-20

**Type:** ACTUAL

#### Start Date
**Date:** 2022-05-15

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-18
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Cairo University

#### Lead Sponsor

**Class:** OTHER

**Name:** Mohamed Magdy Mostafa Shehata

#### Responsible Party

**Investigator Affiliation:** Cairo University

**Investigator Full Name:** Mohamed Magdy Mostafa Shehata

**Investigator Title:** doctor

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** the goal of this clinical trial is to learn if the new osseo-densification technique works to provide enough bone width and quality prior to implant placement in the upper jaw the main question it aims to answer is: Is the use of osseo-densification protocol better than the standard alveolar ridge widening techniques; regarding efficiency and comfort in obtaining sufficient alveolar ridge width in horizontally atrophic alveolar ridges?

**Detailed Description:** a new osseo-densification protocol using specially designed Densah burs was compared to conventional hand Osteotome technique to test its efficiency in providing sufficient bone quantity and quality in cases of horizontally deficient maxillary edentulous alveolar ridge sites that require expansion prior to dental implant placement

### Conditions Module

**Conditions:**

- Alveolar Bone Resorption

**Keywords:**

- Densah burs

- Osseodensification

- OsseoHand Osteotomes

- alveolar ridge wideninig

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** a new technique used to provide sufficient alveolar ridge width and enhance bone quality at horizontally deficient maxillary alveolar ridges prior to implant placement. the new technique uses specially designed burs called Densah burs that act by causeing bone compaction rather than bone removing from the osteotomy site

##### Masking Info

**Masking:** NONE

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 18

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** the group in which alveloalr ridge widening is done using densah burs, it is the study group

**Intervention Names:**

- Procedure: Alveolar ridge wideninig via applying osseodensification protocol using densah burs

**Label:** intervention group osseodensification

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** the group in which alveolar ridge expansion is done using hand driven osteotomes . it is the conventional froup

**Intervention Names:**

- Procedure: Alveolar ridge widening via hand osteotomes

**Label:** conventional osteotome group

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- intervention group osseodensification

**Description:** alveolar ridge expansion using densah burs in horizontally deficient maxillary alveolar ridges prior to dental implants insertion

**Name:** Alveolar ridge wideninig via applying osseodensification protocol using densah burs

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- conventional osteotome group

**Description:** Alveolar ridge expansion using hand driven osteotomes in horizontally deficient maxillary alveolar ridges prior to dental Implant insertion

**Name:** Alveolar ridge widening via hand osteotomes

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** the amount of ridge width gain is measured both clinically via a caliber and radiographically on CBCT

**Measure:** efficiency of ridge widening technique

**Time Frame:** intraoperative and within 3 days post operative

#### Secondary Outcomes

**Description:** the primary stability of the inserted dental implant is measured via osstell device

**Measure:** primary stability of implant

**Time Frame:** intra-operative after dental implant placement

**Description:** the time required for completion of the surgical procedure is measured in minutes using stop watch

**Measure:** length of surgical procedure

**Time Frame:** During surgery

**Description:** the degree of pain or discomfort examined by the patient during the ridge widening procedure is recorded using a visual scale where 0 represents no pain while 1 minimum pain and 10 is maximum pain

**Measure:** Value of pain

**Time Frame:** Immediate post operative

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Age ≥18 years old.
* In cases of an initial ridge width ≤ 5mm that contains ≤ 2mm of trabecular bone core.
* Alveolar ridges with narrow crest and wider base.

Exclusion Criteria:

* Uncontrolled diabetic patients
* Heavy Smokers
* Patients suffering from osteoporosis
* Patients receiving chemo or radio therapy
* Patients suffering from bleeding disorders
* Patients suffering from intraosseous lesions at the proposed site of implant
* Patients with insufficient alveolar bone hight less than 10 mm.
* Resorbed ridge with a narrow base.

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Cairo

**Country:** Egypt

**Facility:** Mohamed Magdy Mostafa shehata

**Zip:** 11799

#### Overall Officials

**Official 1:**

**Affiliation:** Cairo University

**Name:** Mohamed M Shehata

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Access Criteria:** IDP will be shared with researchers and clinical investigators who require them for further systematic review or retrograde studies via contacting the principal investigator through email

**Description:** all IPD that underlie results in a publication

**Info Types:**

- STUDY_PROTOCOL

- SAP

**IPD Sharing:** YES

**Time Frame:** within 6 months from publication

### References Module

#### References

**Citation:** Tian JH, Neiva R, Coelho PG, Witek L, Tovar NM, Lo IC, Gil LF, Torroni A. Alveolar Ridge Expansion: Comparison of Osseodensification and Conventional Osteotome Techniques. J Craniofac Surg. 2019 Mar/Apr;30(2):607-610. doi: 10.1097/SCS.0000000000004956.

**PMID:** 30507887

**Citation:** Bassetti MA, Bassetti RG, Bosshardt DD. The alveolar ridge splitting/expansion technique: a systematic review. Clin Oral Implants Res. 2016 Mar;27(3):310-24. doi: 10.1111/clr.12537. Epub 2015 Jan 14.

**PMID:** 25586966

**Citation:** Jha N, Choi EH, Kaushik NK, Ryu JJ. Types of devices used in ridge split procedure for alveolar bone expansion: A systematic review. PLoS One. 2017 Jul 21;12(7):e0180342. doi: 10.1371/journal.pone.0180342. eCollection 2017.

**PMID:** 28732054

**Citation:** Inchingolo AD, Inchingolo AM, Bordea IR, Xhajanka E, Romeo DM, Romeo M, Zappone CMF, Malcangi G, Scarano A, Lorusso F, Isacco CG, Marinelli G, Contaldo M, Ballini A, Inchingolo F, Dipalma G. The Effectiveness of Osseodensification Drilling Protocol for Implant Site Osteotomy: A Systematic Review of the Literature and Meta-Analysis. Materials (Basel). 2021 Feb 28;14(5):1147. doi: 10.3390/ma14051147.

**PMID:** 33671038

**Citation:** Padhye NM, Padhye AM, Bhatavadekar NB. Osseodensification -- A systematic review and qualitative analysis of published literature. J Oral Biol Craniofac Res. 2020 Jan-Mar;10(1):375-380. doi: 10.1016/j.jobcr.2019.10.002. Epub 2019 Nov 2.

**PMID:** 31737477

**Citation:** Witek L, Alifarag AM, Tovar N, Lopez CD, Gil LF, Gorbonosov M, Hannan K, Neiva R, Coelho PG. Osteogenic parameters surrounding trabecular tantalum metal implants in osteotomies prepared via osseodensification drilling. Med Oral Patol Oral Cir Bucal. 2019 Nov 1;24(6):e764-e769. doi: 10.4317/medoral.23108.

**PMID:** 31655837

**Citation:** Starch-Jensen T, Becktor JP. Maxillary Alveolar Ridge Expansion with Split-Crest Technique Compared with Lateral Ridge Augmentation with Autogenous Bone Block Graft: a Systematic Review. J Oral Maxillofac Res. 2019 Dec 30;10(4):e2. doi: 10.5037/jomr.2019.10402. eCollection 2019 Oct-Dec.

**PMID:** 32158526

**Citation:** Demetriades N, Park JI, Laskarides C. Alternative bone expansion technique for implant placement in atrophic edentulous maxilla and mandible. J Oral Implantol. 2011 Aug;37(4):463-71. doi: 10.1563/AAID-JOI-D-10-00028. Epub 2010 Jul 21.

**PMID:** 20662673

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001847

- Term: Bone Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC07

- Name: Mouth and Tooth Diseases

### Condition Browse Module - Browse Leaves

- ID: M5141

- Name: Bone Resorption

- Relevance: HIGH

- As Found: Bone Resorption

- ID: M12026

- Name: Mouth, Edentulous

- Relevance: LOW

- As Found: Unknown

- ID: M5126

- Name: Bone Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001862

- Term: Bone Resorption

### Misc Info Module

- Version Holder: 2024-05-31
