Alveolar Bone ResorptionNCT06426719
Efficiency of Using Osseodensification Protocol
A study testing Alveolar ridge wideninig via applying osseodensification protocol using densah burs and Alveolar ridge widening via hand osteotomes in people with Alveolar Bone Resorption, run by Mohamed Magdy Mostafa Shehata at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Resorption
- What is being tested?
- Alveolar ridge wideninig via applying osseodensification protocol using densah burs and Alveolar ridge widening via hand osteotomes
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteEgypt
- Study dates
- 15 May 2022to 15 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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?
Read the 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
- Alveolar Bone Resorption
- Being tested
- Alveolar ridge wideninig via applying osseodensification protocol using densah burs, Alveolar ridge widening via hand osteotomes
- Keywords
- Densah burs, Osseodensification, OsseoHand Osteotomes, alveolar ridge wideninig
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alveolar ridge wideninig via applying osseodensification protocol using densah bursProcedure or surgery
alveolar ridge expansion using densah burs in horizontally deficient maxillary alveolar ridges prior to dental implants insertion
Alveolar ridge widening via hand osteotomesProcedure or surgery
Alveolar ridge expansion using hand driven osteotomes in horizontally deficient maxillary alveolar ridges prior to dental Implant insertion
| Study group | Role | What they receive |
|---|---|---|
| intervention group osseodensification | Experimental | the group in which alveloalr ridge widening is done using densah burs, it is the study group Receives: 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 Receives: Procedure: Alveolar ridge widening via hand osteotomes |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficiency of ridge widening technique
the amount of ridge width gain is measured both clinically via a caliber and radiographically on CBCT
Measured: intraoperative and within 3 days post operative
Secondary outcomes (3)
primary stability of implant
the primary stability of the inserted dental implant is measured via osstell device
Measured: 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
Measured: 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
Measured: Immediate post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2024
- Study start15 May 2022
- Primary completion20 Jan 2024
- Study completion15 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Alveolar Bone ResorptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mohamed Magdy Mostafa Shehata
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Sponsor-investigator, Mohamed Magdy Mostafa Shehata, Cairo University
- Investigators
- Mohamed M Shehata, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06426719
- Sponsor's protocol ID
- 28908210103756
- Status last verified
- May 2024
- First submitted
- 9 May 2024
- Last updated
- 23 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Publications
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.
PubMed 30507887Bassetti 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.
PubMed 25586966Jha 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.
PubMed 28732054Inchingolo 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.
PubMed 33671038Padhye 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.
PubMed 31737477Witek 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.
PubMed 31655837Starch-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.
PubMed 32158526Demetriades 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.
PubMed 20662673
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of Using Osseodensification Protocol for Alveolar Ridge Expansion in Edentulous Alveolar Ridges
- ClinicalTrials.gov ID
- NCT06426719
- Acronym / sponsor ID
- 28908210103756
- Conditions
- Alveolar Bone Resorption
- Keywords
- Densah burs, Osseodensification, OsseoHand Osteotomes, alveolar ridge wideninig
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Mohamed Magdy Mostafa ShehataUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 15 May 2022 (actual)
- Primary completion
- 20 Jan 2024 (actual)
- Study completion
- 15 Feb 2024 (actual)
- First posted
- 23 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| intervention group osseodensification | Experimental | Procedure: Alveolar ridge wideninig via applying osseodensification protocol using densah bursthe group in which alveloalr ridge widening is done using densah burs, it is the study group |
| conventional osteotome group | Active comparator | Procedure: Alveolar ridge widening via hand osteotomesthe group in which alveolar ridge expansion is done using hand driven osteotomes . it is the conventional froup |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- Uncontrolled diabetic patients
- Heavy Smokers
- Patients suffering from osteoporosis
- Patients receiving chemo or radio therapy
- Patients suffering from bleeding disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alveolar ridge wideninig via applying osseodensification protocol using densah bursalveolar ridge expansion using densah burs in horizontally deficient maxillary alveolar ridges prior to dental implants insertion | Procedure or surgery | intervention group osseodensification |
| Alveolar ridge widening via hand osteotomesAlveolar ridge expansion using hand driven osteotomes in horizontally deficient maxillary alveolar ridges prior to dental Implant insertion | Procedure or surgery | conventional osteotome group |
Primary outcome
efficiency of ridge widening technique
Time frame: intraoperative and within 3 days post operative
the amount of ridge width gain is measured both clinically via a caliber and radiographically on CBCT
3 secondary outcomes
primary stability of implant
Time frame: intra-operative after dental implant placement
length of surgical procedure
Time frame: During surgery
Value of pain
Time frame: Immediate post operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
- Results publication: PubMed 30507887Tian 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.
- Results publication: PubMed 25586966Bassetti 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.
- Results publication: PubMed 28732054Jha 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.
- Results publication: PubMed 33671038Inchingolo 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.
- Results publication: PubMed 31737477Padhye 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.
- Results publication: PubMed 31655837Witek 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.
- Results publication: PubMed 32158526Starch-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.
- Results publication: PubMed 20662673Demetriades 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.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed M Shehata principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alveolar ridge wideninig via applying osseodensification protocol using densah burs and Alveolar ridge widening via hand osteotomes in people with Alveolar Bone Resorption, run by Mohamed Magdy Mostafa Shehata at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
efficiency of ridge widening technique (time frame: intraoperative and within 3 days post operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06426719, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2024.