Efficiency of Using Osseodensification Protocol

Alveolar Bone Resorption Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06426719
• Other study ID #: 28908210103756
• Status: Completed
• Phase: N/A
• Start date: May 15, 2022
• Est. completion date: February 15, 2024

Study information

• Verified date: May 2024
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: February 15, 2024
• Est. primary completion date: January 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alveolar Bone Resorption
• Bone Resorption

Intervention

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

Locations

Country	Name	City	State
Egypt	Mohamed Magdy Mostafa shehata	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Mohamed Magdy Mostafa Shehata	Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (8)

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. — View 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. — View 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 Im — View 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. — View 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. — View 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. — View 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. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	primary stability of implant	the primary stability of the inserted dental implant is measured via osstell device	intra-operative after dental implant placement
Secondary	length of surgical procedure	the time required for completion of the surgical procedure is measured in minutes using stop watch	During surgery
Secondary	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