Efficiency of Using Osseodensification Protocol

NCT ID: NCT06426719

Last Updated: 2024-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-15

Study Completion Date

2024-02-15

Brief Summary

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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

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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

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Alveolar Bone Resorption

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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intervention group osseodensification

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

Group Type EXPERIMENTAL

Alveolar ridge wideninig via applying osseodensification protocol using densah burs

Intervention Type PROCEDURE

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

conventional osteotome group

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

Group Type ACTIVE_COMPARATOR

Alveolar ridge widening via hand osteotomes

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role collaborator

Mohamed Magdy Mostafa Shehata

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Magdy Mostafa Shehata

doctor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Mohamed M Shehata

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Mohamed Magdy Mostafa shehata

Cairo, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type RESULT
PMID: 30507887 (View on PubMed)

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.

Reference Type RESULT
PMID: 25586966 (View on PubMed)

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.

Reference Type RESULT
PMID: 28732054 (View on PubMed)

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.

Reference Type RESULT
PMID: 33671038 (View on PubMed)

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.

Reference Type RESULT
PMID: 31737477 (View on PubMed)

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.

Reference Type RESULT
PMID: 31655837 (View on PubMed)

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.

Reference Type RESULT
PMID: 32158526 (View on PubMed)

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.

Reference Type RESULT
PMID: 20662673 (View on PubMed)

Other Identifiers

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28908210103756

Identifier Type: -

Identifier Source: org_study_id

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