Atrophy; BoneNCT05593198
Guided Bone Regeneration Versus Bone Block Grafting
A study testing Khoury technique and Guided bone regeneration in people with Atrophy; Bone, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
The purpose of this study is to analyze the volumetric gain and stability of the newly formed bone tissue comparing guided bone regeneration with block graft. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Atrophy; Bone
- What is being tested?
- Khoury technique and Guided bone regeneration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2022to 2 Jul 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients in need of an implant-supported rehabilitation
- Patients requiring bone regeneration
- Healthy patients
- Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) ≤ 15%
- Sufficient mesiodistal and interocclusal space
- At least 6 months of follow-up
Who cannot join
- An American Society of Anesthesiologists physical status classification ≥ III
- General contraindications for surgical treatment or implant placement
- Untreated periodontitis
- Smoking
- Excessive alcohol consumption
- Any drug or medication known to affect oral status and bone turnover or contraindicate surgical treatment
- No residual keratinized tissue at the experimental area
- Unwillingness to return for follow-up examinations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Clinical Trial Comparing the Clinical Measures and the Radiographical Volumetric Outcomes Assessed by Cone Beam Computed Tomography of Guided Bone Regeneration Versus Bone Block Grafting
The purpose of this study is to analyze the volumetric gain and stability of the newly formed bone tissue comparing guided bone regeneration with block graft.
- Conditions
- Atrophy; Bone
- Being tested
- Khoury technique, Guided bone regeneration
- Keywords
- Bone Regeneration
- Medical subject headings
- Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Khoury techniqueProcedure or surgery
the bone block will be used following the principles of the Khoury technique to augment the bone volume.
Guided bone regenerationProcedure or surgery
the membrane and the bone granules will be used to perform the guided bone regeneration technique.
| Study group | Role | What they receive |
|---|---|---|
| Guided bone regeneration | Active comparator | Patients will be treated with guided bone regeneration. Receives: Procedure: Guided bone regeneration |
| Bone block | Experimental | Patients will be treated with bone blocks using the Khoury technique. Receives: Procedure: Khoury technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone volume
the bone volume will be analyzed with the Cone Beam Computed Tomography scan
Measured: 6 Months follow up
Secondary outcomes (3)
Periodontal parameters
the periodontal parameters will be analyzed clinically with the periodontal probe and measured in millimeters. All the periodontal parameters will be combined to describe the periodontal status of the patient.
Measured: 6 Months follow up
Wound healing
the wound healing will be recorded with the Early Wound Healing Score (EHS) ranging from 0 to 10 which includes the following parameters:
- clinical signs of re-epithelialization: 0 points, visible distance between incision margins; 3 points, incision margins in contact; 6 points, merged incision margins.
- clinical signs of haemostasis: 0 points, bleeding at the incision margins; 1 point, presence of fibrin at the incision margins; 2 points, absence of fibrin on the incision margins.
- clinical signs of inflammation: 0 points, redness involving >50% of the incision length and/or pronounced swelling; 1 point, redness involving <50% of the incision length; 2 points, absence of redness along the incision length.
Measured: 2 weeks follow up
Histological analysis
The histological analysis will be performed harvesting a sample during the implant placement. Bone biopsies including both native and regenerated bone will be subjected to digital scanning to analyze the characteristics of newly formed bone, the remaining grafted material, integration of grafted material with newly formed bone, soft tissue, and local inflammation. Histomorphometric analyses will be performed to measure the following parameters: bone tissue area , graft material area , soft tissue area. Bone tissue area , graft material area , soft tissue area will be expressed relative to the total area.
Measured: 6 Months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2022
- Study start1 Nov 2022
- Primary completion1 Jul 2023
- Study completion2 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrophy; BoneStudies 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonio D'Addona, DDS, Principal investigator, Fondazione Policlinico Gemelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05593198
- Sponsor's protocol ID
- 4729
- Status last verified
- Oct 2022
- First submitted
- 5 Sep 2022
- Last updated
- 29 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Clinical Trial Comparing the Clinical Measures and the Radiographical Volumetric Outcomes Assessed by Cone Beam Computed Tomography of Guided Bone Regeneration Versus Bone Block Grafting
- ClinicalTrials.gov ID
- NCT05593198
- Acronym / sponsor ID
- 4729
- Conditions
- Atrophy; Bone
- Keywords
- Bone Regeneration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 2 Jul 2023 (actual)
- First posted
- 25 Oct 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.
The purpose of this study is to analyze the volumetric gain and stability of the newly formed bone tissue comparing guided bone regeneration with block graft.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guided bone regeneration | Active comparator | Procedure: Guided bone regenerationPatients will be treated with guided bone regeneration. |
| Bone block | Experimental | Procedure: Khoury techniquePatients will be treated with bone blocks using the Khoury technique. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients in need of an implant-supported rehabilitation
- Patients requiring bone regeneration
- Healthy patients
- Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) ≤ 15%
- Sufficient mesiodistal and interocclusal space
Key exclusion criteria (8 listed)
- An American Society of Anesthesiologists physical status classification ≥ III
- General contraindications for surgical treatment or implant placement
- Untreated periodontitis
- Smoking
- Excessive alcohol consumption
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 |
|---|---|---|
| Khoury techniquethe bone block will be used following the principles of the Khoury technique to augment the bone volume. | Procedure or surgery | Bone block |
| Guided bone regenerationthe membrane and the bone granules will be used to perform the guided bone regeneration technique. | Procedure or surgery | Guided bone regeneration |
Primary outcome
Bone volume
Time frame: 6 Months follow up
the bone volume will be analyzed with the Cone Beam Computed Tomography scan
3 secondary outcomes
Periodontal parameters
Time frame: 6 Months follow up
Wound healing
Time frame: 2 weeks follow up
Histological analysis
Time frame: 6 Months follow up
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 29 Aug 2023.
- Individual participant dataSharing planned: No
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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.
Antonio D'Addona, DDS principal investigator
Fondazione Policlinico Gemelli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Khoury technique and Guided bone regeneration in people with Atrophy; Bone, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 6 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 29 Aug 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 Italy. 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?
Bone volume (time frame: 6 Months follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Aug 2023.