Efficiency of Using Osseodensification Protocol

Efficiency of Using Osseodensification Protocol for Alveolar Ridge Expansion in Edentulous Alveolar Ridges

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?

Study Overview

• Status: Completed
• Conditions: Alveolar Bone Resorption
• Intervention / Treatment: Procedure: Alveolar ridge wideninig via applying osseodensification protocol using densah burs; Procedure: Alveolar ridge widening via hand osteotomes

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

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11799
    • Mohamed Magdy Mostafa shehata

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention group osseodensification; 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; alveolar ridge expansion using densah burs in horizontally deficient maxillary alveolar ridges prior to dental implants insertion
Active Comparator: conventional osteotome group; 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; Alveolar ridge expansion using hand driven osteotomes in horizontally deficient maxillary alveolar ridges prior to dental Implant insertion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
primary stability of implant	the primary stability of the inserted dental implant is measured via osstell device	intra-operative after dental implant placement
length of surgical procedure	the time required for completion of the surgical procedure is measured in minutes using stop watch	During surgery
Value of pain	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	Immediate post operative

Collaborators and Investigators

• Sponsor: Mohamed Magdy Mostafa Shehata
• Collaborators: Cairo University
• Investigators: Principal Investigator: Mohamed M Shehata, Cairo University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2022
• Primary Completion (Actual): January 20, 2024
• Study Completion (Actual): February 15, 2024

Study Registration Dates

• First Submitted: May 9, 2024
• First Submitted That Met QC Criteria: May 18, 2024
• First Posted (Actual): May 23, 2024

Study Record Updates

• Last Update Posted (Actual): May 23, 2024
• Last Update Submitted That Met QC Criteria: May 18, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Osseodensification; Densah burs; OsseoHand Osteotomes; alveolar ridge wideninig
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Bone Resorption
• Other Study ID Numbers: 28908210103756

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all IPD that underlie results in a publication
• IPD Sharing Time Frame: within 6 months from publication
• IPD Sharing 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No