Efficiency of Using Osseodensification Protocol

NCT06426719 | Completed

• 1 other identifier: 28908210103756
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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?

Conditions

Alveolar Bone Resorption

Keywords

Densah burs; Osseodensification; OsseoHand Osteotomes; alveolar ridge wideninig

Outcome Measures

Primary Outcomes (1)

• efficiency of ridge widening technique

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

  intraoperative and within 3 days post operative

Secondary Outcomes (3)

• primary stability of implant

  intra-operative after dental implant placement

• length of surgical procedure

  During surgery

• Value of pain

  Immediate post operative

Study Arms (2)

intervention group osseodensification

EXPERIMENTAL

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

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

conventional osteotome group

ACTIVE COMPARATOR

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

Procedure: Alveolar ridge widening via hand osteotomes

Interventions

Alveolar ridge wideninig via applying osseodensification protocol using densah burs PROCEDURE

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

intervention group osseodensification

Alveolar ridge widening via hand osteotomes PROCEDURE

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

conventional osteotome group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mohamed Magdy Mostafa Shehata: lead
• Cairo University: collaborator

Study Sites (1)

Mohamed Magdy Mostafa shehata

Cairo, 11799, Egypt

Location

Related Publications (8)

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

Study Officials

• Mohamed M Shehata

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: doctor

Model Details: 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

Study Record Dates

• First Submitted: May 9, 2024
• First Posted: May 23, 2024
• Study Start: May 15, 2022
• Primary Completion: January 20, 2024
• Study Completion: February 15, 2024
• Last Updated: May 23, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: within 6 months from publication
• 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

Locations

EG (1)