Bone RegenerationNCT03432702
Horizontal Ridge Augmentation With or Without Autogenous Block Grafts
A study testing Horizontal ridge augmentation in people with Bone Regeneration and Bone Transplantation, run by Universidad Científica del Sur at 1 site in Peru.
Trial summary
To evaluate dimensional bone alterations following horizontal ridge augmentation using guided bone regeneration (GBR) with or without autogenous block graft (ABG) for the rehabilitation of atrophic jaws with dental implants. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bone Regeneration, Bone Transplantation, Bone Substitutes
- What is being tested?
- Horizontal ridge augmentation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 sitePeru
- Study dates
- 1 May 2012to 1 Jun 2017
- 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
- 18 years old, who required an implant supported restoration in at least one site, with severe atrophy of the alveolar ridge in the horizontal plane (class III-IV atrophy according to Cawood and Howell classification),
- adequate oral hygiene
- no history of previous bone augmentation procedures at the implant site, and
- able to understand and sign an informed consent form.
Who cannot join
- uncontrolled systemic conditions, irradiation in the head and neck area, - immunosuppressed or immunocompromised,
- presented with oral disorders (such as lichen planus),
- treated or under treatment with intravenous amino-bisphosphonates,
- untreated periodontitis, poor oral hygiene and motivation,
- parafunctional habits,
- pregnant or lactating,
Show all 11Show fewer
- drug or alcohol abuse,
- psychiatric disorders,
- a history (within the last 3 months) of using (at least weekly or more frequently) smokeless chewing tobacco, smoking a pipe, cigar or cigarette (at a rate of more than 10 cigarettes per day),
- acute/chronic infection/inflammation in the area, or
- an extraction with less than 3 months of healing
Trial locations and contacts
1 site in 1 country.
Peru1 site
Periodontal Postgraduate Clinic at the Faculty of Dentistry, Científica del Sur University
Lima
About this study
Official title: Horizontal Ridge Augmentation With Guided Bone Regeneration Using Particulate Xenogenic Bone Substitutes With or Without Autogenous Block Grafts: A Randomized Controlled Trial
To evaluate dimensional bone alterations following horizontal ridge augmentation using guided bone regeneration (GBR) with or without autogenous block graft (ABG) for the rehabilitation of atrophic jaws with dental implants.
Read the detailed description
Forty-two patients with 42 severe horizontal bone atrophy sites in the maxilla or mandible will be randomly assigned to two groups: ABG or GBR.
In the ABG group, a combination of ABG with particulate xenograft, covered with collagen membrane, will be used, while only a combination of particulate xenograft and collagen membrane alone will be in the GBR group. After 6-9 months of healing, implants were inserted. All implants will be definitively restored 6 months after implant placement. Radiographic examination (cone beam computed tomograms, CBCT) will be performed to evaluate the amount of horizontal bone width (HBW) gain immediately after bone grafting procedure (T0), at 6 months (T6), and at 18 months (T18). Patient demographic information, amount of width augmentation, implant survival, complications, and contributing factors will be gathered and analyzed.
- Conditions
- Bone Regeneration, Bone Transplantation, Bone Substitutes, Cone-beam Computed Tomography, Dental Implants
- Being tested
- Horizontal ridge augmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Horizontal ridge augmentationProcedure or surgery
Also called Alveolar ridge augmentation, Bone grafting
Surgical procedures performed to provide the alveolar ridge with enough width and height to allow for the prosthetically driven implant placement.
| Study group | Role | What they receive |
|---|---|---|
| Alveolar ridge augmentation without ABG | Active comparator | Horizontal ridge augmentation using guided bone regeneration without autogenous block graft (ABG) Receives: Procedure: Horizontal ridge augmentation |
| Alveolar ridge augmentation with ABG | Experimental | Horizontal ridge augmentation using guided bone regeneration with autogenous block graft (ABG). Receives: Procedure: Horizontal ridge augmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in horizontal alveolar ridge width from pre-operatively (baseline) to 12 months after implant loading.
Horizontal alveolar ridge changes in being assessed in the regenerated area. This outcome will be evaluated from pre-operatively (baseline), to 12 months after implant loading by measuring the alveolar ridge width at various points on the cross-sectional images using data obtained from CBCT scans.
Measured: From pre-operatively (baseline) to 12 months after implant loading.
Secondary outcomes (3)
Implant failure
The presence of an implant that requires implant removal (e.g., implant mobility).
Measured: At 6 months (T6), and at 18 months (T18) after implant placement.
Complications
Assessments of complications related to study procedures will be recorded during the follow up period.
Measured: 6 months
Regrafting necessity
Number of implants that needed regrafting to allow for ideal prosthetically driven implant placement.
Measured: At 6 months (T6).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2018
- Study start1 May 2012
- Primary completion1 Sep 2015
- Study completion1 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone RegenerationStudies 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
- Model description
- Single center, prospective, controlled, parallel-armed, randomized clinical trial.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Científica del Sur
- Sponsor type
- University, hospital or other
- Collaborators
- NYU Langone Health
- Responsible party
- Sponsor
- Investigators
- Gerardo Mendoza-Azpur, DDS, Principal investigator, Científica del Sur University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03432702
- Sponsor's protocol ID
- 00013
- Status last verified
- Feb 2018
- First submitted
- 31 Jan 2018
- Last updated
- 14 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- 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 14 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Horizontal Ridge Augmentation With Guided Bone Regeneration Using Particulate Xenogenic Bone Substitutes With or Without Autogenous Block Grafts: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03432702
- Acronym / sponsor ID
- 00013
- Conditions
- Bone Regeneration, Bone Transplantation, Bone Substitutes, Cone-beam Computed Tomography, Dental Implants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Universidad Científica del SurUniversity, hospital or other
- Collaborators
- NYU Langone Health
- Study start
- 1 May 2012 (actual)
- Primary completion
- 1 Sep 2015 (actual)
- Study completion
- 1 Jun 2017 (actual)
- First posted
- 14 Feb 2018 (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.
To evaluate dimensional bone alterations following horizontal ridge augmentation using guided bone regeneration (GBR) with or without autogenous block graft (ABG) for the rehabilitation of atrophic jaws with dental implants.
Detailed description
Forty-two patients with 42 severe horizontal bone atrophy sites in the maxilla or mandible will be randomly assigned to two groups: ABG or GBR.
In the ABG group, a combination of ABG with particulate xenograft, covered with collagen membrane, will be used, while only a combination of particulate xenograft and collagen membrane alone will be in the GBR group. After 6-9 months of healing, implants were inserted. All implants will be definitively restored 6 months after implant placement. Radiographic examination (cone beam computed tomograms, CBCT) will be performed to evaluate the amount of horizontal bone width (HBW) gain immediately after bone grafting procedure (T0), at 6 months (T6), and at 18 months (T18). Patient demographic information, amount of width augmentation, implant survival, complications, and contributing factors will be gathered and analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Single center, prospective, controlled, parallel-armed, randomized clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Alveolar ridge augmentation without ABG | Active comparator | Procedure: Horizontal ridge augmentationHorizontal ridge augmentation using guided bone regeneration without autogenous block graft (ABG) |
| Alveolar ridge augmentation with ABG | Experimental | Procedure: Horizontal ridge augmentationHorizontal ridge augmentation using guided bone regeneration with autogenous block graft (ABG). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years old, who required an implant supported restoration in at least one site, with severe atrophy of the alveolar ridge in the horizontal plane (class III-IV atrophy according to Cawood and Howell classification),
- adequate oral hygiene
- no history of previous bone augmentation procedures at the implant site, and
- able to understand and sign an informed consent form.
Key exclusion criteria (11 listed)
- uncontrolled systemic conditions, irradiation in the head and neck area, - immunosuppressed or immunocompromised,
- presented with oral disorders (such as lichen planus),
- treated or under treatment with intravenous amino-bisphosphonates,
- untreated periodontitis, poor oral hygiene and motivation,
- parafunctional habits,
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 |
|---|---|---|
| Horizontal ridge augmentationAlso: Alveolar ridge augmentation, Bone graftingSurgical procedures performed to provide the alveolar ridge with enough width and height to allow for the prosthetically driven implant placement. | Procedure or surgery | Alveolar ridge augmentation with ABG, Alveolar ridge augmentation without ABG |
Primary outcome
Changes in horizontal alveolar ridge width from pre-operatively (baseline) to 12 months after implant loading.
Time frame: From pre-operatively (baseline) to 12 months after implant loading.
Horizontal alveolar ridge changes in being assessed in the regenerated area. This outcome will be evaluated from pre-operatively (baseline), to 12 months after implant loading by measuring the alveolar ridge width at various points on the cross-sectional images using data obtained from CBCT scans.
3 secondary outcomes
Implant failure
Time frame: At 6 months (T6), and at 18 months (T18) after implant placement.
Complications
Time frame: 6 months
Regrafting necessity
Time frame: At 6 months (T6).
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 14 Feb 2018.
- Individual participant dataSharing planned: No
Related trials for Bone Regeneration
Not yet recruitingEarly Phase 1
The Efficacy of Exosomes Combined With Synthetic Bone Graft for the Treatment of Periodontal Intra-bony Defects
Intra-Bony Defects in Periodontitis Patients
Active, not recruitingObservational study
Long-Term Stability of Soft and Hard Tissues After Guided Bone Regeneration in the Maxillary Anterior Region
Alveolar Bone Deficiency
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Guided Bone Regeneration Using Polydioxanone (PDO) Membrane in Sockets After Tooth Extraction
Surgery, Oral
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
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.
Gerardo Mendoza-Azpur, DDS principal investigator
Científica del Sur 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 Horizontal ridge augmentation in people with Bone Regeneration and Bone Transplantation, run by Universidad Científica del Sur at 1 site in Peru.
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 4 inclusion and 11 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 14 Feb 2018. 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 Peru. 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?
Changes in horizontal alveolar ridge width from pre-operatively (baseline) to 12 months after implant loading. (time frame: From pre-operatively (baseline) to 12 months after implant loading.). 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 14 Feb 2018.