Ridge AugmentationNCT05407363

Ridge Augmentation With Simultaneous Implant Placement Using Bone Blocks With Autogenous Tooth Graft

A study testing ABB and ATG with simultaneous implant placement, XBB and ATG with simultaneous implant placement and ABB and ABG with simultaneous implant placement in people with Ridge Augmentation and Implant, run by Kafrelsheikh University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Autogenous bone, with its osteogenic, osteoinductive, and osteo-conductive characteristics has been used for bone grafts with optimal integration into host tissues. For this reason, autogenous bone has been often considered the gold standard of bone regeneration material. Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Ridge Augmentation, Implant, Autogenous Tooth Graft
What is being tested?: ABB and ATG with simultaneous implant placement, XBB and ATG with simultaneous implant placement and ABB and ABG with simultaneous implant placement
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteEgypt
Study dates: 1 Apr 2022to 20 Aug 2023
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 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Teeth with buccal bone destruction by periodontal disease and need extraction (horizontal or vertical bone defect);
Absence of acute inflammation;
Absence of uncontrolled systemic illness that would preclude implantation;
Good dental and systemic healthy conditions;
Patients were willing and able to return for multiple follow-up visits.

Who cannot join

Patients with systemic illnesses,
psychological abnormalities,
para-functional habit,
smokers or alcoholics,
pregnant and lactating patients,
patients undergoing or recently completed radiotherapy or chemotherapy,
patients on drugs affecting the healing process,
patients with endodontically treated teeth

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Faculty of Dentistry, Kafrelsheikh University
Kafr ash Shaykh, 33511

Other trials in Egypt

About this study

Official title: Ridge Augmentation With Simultaneous Implant Placement Using Xenogenic Blocks or Autogenous Bone Blocks With Autogenous Tooth Graft

Bone substitutes, including allografts, xenografts, and alloplasts have been used successfully as alternatives to autogenous bone grafts in ridge augmentation procedures.

In 2008, autogenous tooth bone graft (ATG) was introduced and used for the first time as a bone grafting material for GBR. The tooth contents are extremely similar to that of the alveolar bone. The enamel inorganic, organic, and water contents are 95 percent, 0.6 percent, and 4 percent, respectively. However, in the dentin, the percentages are 70 to 75 percent, 20 percent, and 10 percent, respectively. They are 65 percent, 25 percent, and 10 percent, respectively, when compared to the alveolar bone content.

The aim of this study is to compare ridge augmentation using autogenous bone block (ABB) with immediate implant placement and filling the generated gap with autogenous bone graft (ABG) or ATG, or ridge augmentation using xenograft bone block (XBB) with immediate implant placement and filling the generated gap with ATG.

Conditions: Ridge Augmentation, Implant, Autogenous Tooth Graft
Being tested: ABB and ATG with simultaneous implant placement, XBB and ATG with simultaneous implant placement, ABB and ABG with simultaneous implant placement

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ABB and ATG with simultaneous implant placementProcedure or surgery
Ridge augmentation using ABB and ATG as a graft material with simultaneous implant placement
XBB and ATG with simultaneous implant placementProcedure or surgery
Ridge augmentation using XBB and ATG as a graft material with simultaneous implant placement
ABB and ABG with simultaneous implant placementProcedure or surgery
Ridge augmentation using ABB and ABG as a graft material with simultaneous implant placement

Study groups in NCT05407363
Study group	Role	What they receive
ABB and ATG with simultaneous implant placement	Experimental	Using ABB with ATG to fill the gap around simultaneously placed dental implants Receives: Procedure: ABB and ATG with simultaneous implant placement
XBB and ATG with simultaneous implant placement	Experimental	Using XBB with ATG to fill the gap around simultaneously placed dental implants Receives: Procedure: XBB and ATG with simultaneous implant placement
ABB and ABG with immediate implant	Active comparator	Using ABB with ABG to fill the gap around immediately placed dental implants Receives: Procedure: ABB and ABG with simultaneous implant placement

What is being measured

The primary outcome is the main question the study is designed to answer.

Clinical evaluation probing pocket depth and amount of bone around simultaneously placed dental implants
Changes on pocket depth and amount of bone using ABG or ATG with ABB or XBB around simultaneously placed dental implants
Measured: 9 months
radiographic outcome measuring the amount of bone around simultaneously placed dental implants
the radiographic outcome by measuring the amount of bone by using ATG or ABG on bone formation with ABB or XBB around simultaneously placed dental implants
Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 202220 Aug 2023

First posted7 Jun 2022
Study start1 Apr 2022
Primary completion12 Aug 2023
Study completion20 Aug 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Ridge AugmentationStudies 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05407363
Sponsor's protocol ID: KFSIRB200-72
Status last verified: Dec 2023
First submitted: 1 Apr 2022
Last updated: 22 Dec 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Evaluating the Barrier Function, Regenerative Capacity, and Soft Tissue Outcomes of Acellular Dermal Matrix
Acellular Dermal Matrix, Bone Grafting
Not yet recruiting
Autogenous and Xenograft Bone Mix in Alveolar Ridge Reconstruction
Horizontal Alveolar Ridge Deficiency
Not yet recruiting
Comparison of Three Autogenous Bone and Xenograft Ratios for Horizontal Ridge Augmentation
Horizontal Alveolar Ridge Deficiency
Not yet recruitingPhase 1/2
Alveolar Ridge Preservation (ARP) Study Using Alloplastic Biomaterial and a Resorbable Synthetic Membrane. A Digital Workflow (CBCT/Scanner) Evaluates Hard and Soft Tissue Volumetric Changes at 4 Months, Validating Support for the Gingival Phenotype and Buccal Bone Plate.
Alveolar Ridge Augmentation, Bone Substitutes
Not yet recruiting
Comparison of Two Autogenous Bone and Xenograft Ratios for Horizontal Ridge Augmentation
Horizontal Alveolar Ridge Deficiency

All Ridge Augmentation trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Ridge Augmentation With Simultaneous Implant Placement Using Xenogenic Blocks or Autogenous Bone Blocks With Autogenous Tooth Graft
ClinicalTrials.gov ID: NCT05407363
Acronym / sponsor ID: KFSIRB200-72
Conditions: Ridge Augmentation, Implant, Autogenous Tooth Graft
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Kafrelsheikh UniversityUniversity, hospital or other
Study start: 1 Apr 2022 (actual)
Primary completion: 12 Aug 2023 (actual)
Study completion: 20 Aug 2023 (actual)
First posted: 7 Jun 2022 (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.

Bone substitutes, including allografts, xenografts, and alloplasts have been used successfully as alternatives to autogenous bone grafts in ridge augmentation procedures.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
ABB and ATG with simultaneous implant placement	Experimental	Procedure: ABB and ATG with simultaneous implant placementUsing ABB with ATG to fill the gap around simultaneously placed dental implants
XBB and ATG with simultaneous implant placement	Experimental	Procedure: XBB and ATG with simultaneous implant placementUsing XBB with ATG to fill the gap around simultaneously placed dental implants
ABB and ABG with immediate implant	Active comparator	Procedure: ABB and ABG with simultaneous implant placementUsing ABB with ABG to fill the gap around immediately placed dental implants

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Teeth with buccal bone destruction by periodontal disease and need extraction (horizontal or vertical bone defect);
Absence of acute inflammation;
Absence of uncontrolled systemic illness that would preclude implantation;
Good dental and systemic healthy conditions;
Patients were willing and able to return for multiple follow-up visits.

Key exclusion criteria (8 listed)

Patients with systemic illnesses,
psychological abnormalities,
para-functional habit,
smokers or alcoholics,
pregnant and lactating patients,

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
ABB and ATG with simultaneous implant placementRidge augmentation using ABB and ATG as a graft material with simultaneous implant placement	Procedure or surgery	ABB and ATG with simultaneous implant placement
XBB and ATG with simultaneous implant placementRidge augmentation using XBB and ATG as a graft material with simultaneous implant placement	Procedure or surgery	XBB and ATG with simultaneous implant placement
ABB and ABG with simultaneous implant placementRidge augmentation using ABB and ABG as a graft material with simultaneous implant placement	Procedure or surgery	ABB and ABG with immediate implant

Primary outcome

Clinical evaluation probing pocket depth and amount of bone around simultaneously placed dental implants
Time frame: 9 months
Changes on pocket depth and amount of bone using ABG or ATG with ABB or XBB around simultaneously placed dental implants
radiographic outcome measuring the amount of bone around simultaneously placed dental implants
Time frame: 9 months
the radiographic outcome by measuring the amount of bone by using ATG or ABG on bone formation with ABB or XBB around simultaneously placed dental implants

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 22 Dec 2023.

Related trials for Ridge Augmentation

Recruiting
Evaluating the Barrier Function, Regenerative Capacity, and Soft Tissue Outcomes of Acellular Dermal Matrix
Acellular Dermal Matrix, Bone Grafting
Not yet recruiting
Autogenous and Xenograft Bone Mix in Alveolar Ridge Reconstruction
Horizontal Alveolar Ridge Deficiency
Not yet recruiting
Comparison of Three Autogenous Bone and Xenograft Ratios for Horizontal Ridge Augmentation
Horizontal Alveolar Ridge Deficiency
Not yet recruitingPhase 1/2
Alveolar Ridge Preservation (ARP) Study Using Alloplastic Biomaterial and a Resorbable Synthetic Membrane. A Digital Workflow (CBCT/Scanner) Evaluates Hard and Soft Tissue Volumetric Changes at 4 Months, Validating Support for the Gingival Phenotype and Buccal Bone Plate.
Alveolar Ridge Augmentation, Bone Substitutes
Not yet recruiting
Comparison of Two Autogenous Bone and Xenograft Ratios for Horizontal Ridge Augmentation
Horizontal Alveolar Ridge Deficiency

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.

Dalia R Issa, PhD principal investigator

Kafrelsheikh University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 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 22 Dec 2023. 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?

Clinical evaluation probing pocket depth and amount of bone around simultaneously placed dental implants (time frame: 9 months). The study lists 2 primary outcomes in all. 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 NCT05407363.

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 22 Dec 2023.