Dental ImplantationPhase 4NCT01154868
Clinical and Histological Evaluation of Healos® for Alveolar Ridge Augmentation
A Phase 4 study testing Alveolar ridge augmentation in people with Dental Implantation, run by William Giannobile at 1 site in United States.
Trial summary
The purpose of this study is to document and evaluate how a bone graft material (Healos®) can help rebuild bone width. Dental implants can only be placed when enough bone is found and this bone graft may help to rebuild bone width for dental implant placement. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Implantation
- What is being tested?
- Alveolar ridge augmentation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Feb 2011
- Phase
- Phase 4
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 21 and older
- 2-4 ADJACENT maxillary front teeth missing
- require ridge augmentation and dental implant
- nonsmoker for at least 6 months
- willing to follow oral hygiene instruction and other study instruction
- able to read, understand and sign informed consent
Who cannot join
- Residual upper jaw bone equal to or narrower than 3mm.
- Insufficient gum tissue to obtain wound closure after surgery.
- Clinically significant or unstable (as defined by the investigators) systemic diseases affecting bone or soft tissue growth; or other kidney, liver, heart, thyroid, blood, autoimmune or acute infectious diseases that makes interpretation of the data more difficult
- A history of head \& neck radiation treatment due to certain medical conditions.
- Taking steroids, tetracycline or tetracycline analogs, bone therapeutic levels of fluorides, bisphosphonates, medications affecting bone turnover, antibiotics for >7 days or any investigational drug
- Pregnancy or become pregnant during the length of the study
- Wearing removable partial dentures that may put pressure over the area where the bone graft will be placed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Michigan Center for Oral Health Research
Ann Arbor, Michigan, 48106
About this study
The purpose of this study is to document and evaluate how a bone graft material (Healos®) can help rebuild bone width. Dental implants can only be placed when enough bone is found and this bone graft may help to rebuild bone width for dental implant placement. The ultimate goal of this study is to evaluate how this graft material can help bone healing.
- Conditions
- Dental Implantation
- Being tested
- Alveolar ridge augmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alveolar ridge augmentationProcedure or surgery
Also called Healos
Under local anesthesia, full-thickness mucoperiosteal flaps will be elevated, followed by degranulation, and collection of all clinical measurements. Crestal and vertical releasing cuts will be performed using diamond-coated discs on the edentulous ridge in need of augmentation. A sequence of bone chisels and osteotomes will be used to split the alveolar ridge in half until a desirable width for implant placement is achieved. Healos® will then be inserted between both osseous plates. Fixation screws will be used as needed to stabilize the expanded alveolar ridge. Collagen barrier membranes (Ossix Plus) will be used to cover the osseous wound. Flaps will be approximated to achieve primary wound closure.
| Study group | Role | What they receive |
|---|---|---|
| Healos | Other | Not described Receives: Procedure: Alveolar ridge augmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
horizontal (width) bone gain or loss in millimeters.
Measured: 18 weeks
Secondary outcomes (2)
radiographic bone changes measured using computer tomography
Measured: 18 weeks
percentage of new bone formation in the alveolar bone core biopsies.
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2010 (estimated)
- Study startAug 2010
- Primary completionFeb 2011 (estimated)
- Study completionFeb 2011 (estimated)
Why it stopped: Sponsor withdrew funding of study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Dental ImplantationStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- William Giannobile
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson
- Responsible party
- Sponsor-investigator, William Giannobile, University of Michigan
- Investigators
- William Giannobile, DDS, DMedSc, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01154868
- Sponsor's protocol ID
- HUM00035937
- Status last verified
- Dec 2015
- First submitted
- 29 Jun 2010
- Last updated
- 14 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Engler WO, Ramfjord SP, Hiniker JJ. Healing following simple gingivectomy. A tritiated thymidine radioautographic study. I. Epithelialization. J Periodontol. 1966 Jul-Aug;37(4):298-308. doi: 10.1902/jop.1966.37.4.298. No abstract available.
PubMed 4287364Ramfjord SP, Engler WO, Hiniker JJ. A radioautographic study of healing following simple gingivectomy. II. The connective tissue. J Periodontol. 1966 May-Jun;37(3):179-89. doi: 10.1902/jop.1966.37.3.179. No abstract available.
PubMed 4956575HURLEY LA, STINCHFIELD FE, BASSETT AL, LYON WH. The role of soft tissues in osteogenesis. An experimental study of canine spine fusions. J Bone Joint Surg Am. 1959 Oct;41-A:1243-54. No abstract available.
PubMed 13852565MURRAY G, HOLDEN R, ROSCHLAU W. Experimental and clinical study of new growth of bone in a cavity. Am J Surg. 1957 Mar;93(3):385-7. doi: 10.1016/0002-9610(57)90827-9. No abstract available.
PubMed 13403056Buser DA, Tonetti M. Clinical trials on implants in regenerated bone. Ann Periodontol. 1997 Mar;2(1):329-42. doi: 10.1902/annals.1997.2.1.329.
PubMed 9151565Scipioni A, Calesini G, Micarelli C, Coppe S, Scipioni L. Morphogenic bone splitting: description of an original technique and its application in esthetically significant areas. Int J Prosthodont. 2008 Sep-Oct;21(5):389-97.
PubMed 18950058Simion M, Baldoni M, Zaffe D. Jawbone enlargement using immediate implant placement associated with a split-crest technique and guided tissue regeneration. Int J Periodontics Restorative Dent. 1992;12(6):462-73.
PubMed 1298734Engelke WG, Diederichs CG, Jacobs HG, Deckwer I. Alveolar reconstruction with splitting osteotomy and microfixation of implants. Int J Oral Maxillofac Implants. 1997 May-Jun;12(3):310-8.
PubMed 9197095Coatoam GW, Mariotti A. The segmental ridge-split procedure. J Periodontol. 2003 May;74(5):757-70. doi: 10.1902/jop.2003.74.5.757.
PubMed 12816307Basa S, Varol A, Turker N. Alternative bone expansion technique for immediate placement of implants in the edentulous posterior mandibular ridge: a clinical report. Int J Oral Maxillofac Implants. 2004 Jul-Aug;19(4):554-8.
PubMed 15346753Neen D, Noyes D, Shaw M, Gwilym S, Fairlie N, Birch N. Healos and bone marrow aspirate used for lumbar spine fusion: a case controlled study comparing healos with autograft. Spine (Phila Pa 1976). 2006 Aug 15;31(18):E636-40. doi: 10.1097/01.brs.0000232028.97590.12.
PubMed 16915079
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Histological Evaluation of Healos® for Alveolar Ridge Augmentation
- ClinicalTrials.gov ID
- NCT01154868
- Acronym / sponsor ID
- HUM00035937
- Conditions
- Dental Implantation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor withdrew funding of study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- William GiannobileUniversity, hospital or other
- Collaborators
- Johnson & Johnson
- Study start
- Aug 2010
- Primary completion
- Feb 2011 (estimated)
- Study completion
- Feb 2011 (estimated)
- First posted
- 1 Jul 2010 (estimated)
- 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 document and evaluate how a bone graft material (Healos®) can help rebuild bone width. Dental implants can only be placed when enough bone is found and this bone graft may help to rebuild bone width for dental implant placement. The ultimate goal of this study is to evaluate how this graft material can help bone healing.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healos | Other | Procedure: Alveolar ridge augmentation |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age 21 and older
- 2-4 ADJACENT maxillary front teeth missing
- require ridge augmentation and dental implant
- nonsmoker for at least 6 months
- willing to follow oral hygiene instruction and other study instruction
Key exclusion criteria (7 listed)
- Residual upper jaw bone equal to or narrower than 3mm.
- Insufficient gum tissue to obtain wound closure after surgery.
- Clinically significant or unstable (as defined by the investigators) systemic diseases affecting bone or soft tissue growth; or other kidney, liver, heart, thyroid, blood, autoimmune or acute infectious diseases that makes interpretation of the data more difficult
- A history of head \& neck radiation treatment due to certain medical conditions.
- Taking steroids, tetracycline or tetracycline analogs, bone therapeutic levels of fluorides, bisphosphonates, medications affecting bone turnover, antibiotics for >7 days or any investigational drug
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 augmentationAlso: HealosUnder local anesthesia, full-thickness mucoperiosteal flaps will be elevated, followed by degranulation, and collection of all clinical measurements. Crestal and vertical releasing cuts will be performed using diamond-coated discs on the edentulous ridge in need of augmentation. A sequence of bone chisels and osteotomes will be used to split the alveolar ridge in half until a desirable width for implant placement is achieved. Healos® will then be inserted between both osseous plates. Fixation screws will be used as needed to stabilize the expanded alveolar ridge. Collagen barrier membranes (Ossix Plus) will be used to cover the osseous wound. Flaps will be approximated to achieve primary wound closure. | Procedure or surgery | Healos |
Primary outcome
horizontal (width) bone gain or loss in millimeters.
Time frame: 18 weeks
2 secondary outcomes
radiographic bone changes measured using computer tomography
Time frame: 18 weeks
percentage of new bone formation in the alveolar bone core biopsies.
Time frame: 18 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2015.
- Background: PubMed 4287364Engler WO, Ramfjord SP, Hiniker JJ. Healing following simple gingivectomy. A tritiated thymidine radioautographic study. I. Epithelialization. J Periodontol. 1966 Jul-Aug;37(4):298-308. doi: 10.1902/jop.1966.37.4.298. No abstract available.
- Background: PubMed 4956575Ramfjord SP, Engler WO, Hiniker JJ. A radioautographic study of healing following simple gingivectomy. II. The connective tissue. J Periodontol. 1966 May-Jun;37(3):179-89. doi: 10.1902/jop.1966.37.3.179. No abstract available.
- Background: PubMed 13852565HURLEY LA, STINCHFIELD FE, BASSETT AL, LYON WH. The role of soft tissues in osteogenesis. An experimental study of canine spine fusions. J Bone Joint Surg Am. 1959 Oct;41-A:1243-54. No abstract available.
- Background: PubMed 13403056MURRAY G, HOLDEN R, ROSCHLAU W. Experimental and clinical study of new growth of bone in a cavity. Am J Surg. 1957 Mar;93(3):385-7. doi: 10.1016/0002-9610(57)90827-9. No abstract available.
- Background: PubMed 9151565Buser DA, Tonetti M. Clinical trials on implants in regenerated bone. Ann Periodontol. 1997 Mar;2(1):329-42. doi: 10.1902/annals.1997.2.1.329.
- Background: PubMed 18950058Scipioni A, Calesini G, Micarelli C, Coppe S, Scipioni L. Morphogenic bone splitting: description of an original technique and its application in esthetically significant areas. Int J Prosthodont. 2008 Sep-Oct;21(5):389-97.
- Background: PubMed 1298734Simion M, Baldoni M, Zaffe D. Jawbone enlargement using immediate implant placement associated with a split-crest technique and guided tissue regeneration. Int J Periodontics Restorative Dent. 1992;12(6):462-73.
- Background: PubMed 9197095Engelke WG, Diederichs CG, Jacobs HG, Deckwer I. Alveolar reconstruction with splitting osteotomy and microfixation of implants. Int J Oral Maxillofac Implants. 1997 May-Jun;12(3):310-8.
- Background: PubMed 12816307Coatoam GW, Mariotti A. The segmental ridge-split procedure. J Periodontol. 2003 May;74(5):757-70. doi: 10.1902/jop.2003.74.5.757.
- Background: PubMed 15346753Basa S, Varol A, Turker N. Alternative bone expansion technique for immediate placement of implants in the edentulous posterior mandibular ridge: a clinical report. Int J Oral Maxillofac Implants. 2004 Jul-Aug;19(4):554-8.
- Background: PubMed 16915079Neen D, Noyes D, Shaw M, Gwilym S, Fairlie N, Birch N. Healos and bone marrow aspirate used for lumbar spine fusion: a case controlled study comparing healos with autograft. Spine (Phila Pa 1976). 2006 Aug 15;31(18):E636-40. doi: 10.1097/01.brs.0000232028.97590.12.
Related trials for Dental Implantation
Not yet recruiting
Free Soft Tissue Grafts (FSTG) Using Autograft Palatal Donor Tissue vs. Xenograft Collagen Matrix (Zderm™)
Gingival Recession Localized Moderate, Dental Implant
Not yet recruiting
Safety Assessment of Placing a Single Dental Implant Without Antibiotic Prophylaxis in Simple Cases: A Pilot Study
Tooth Loss and Rehabillitation, Dental Implant Failure
RecruitingObservational study
Clinical and Radiographic Evaluation of Dentsply Sirona PrimeTaper Implants
Dental Implants
Active, not recruiting
The Aim of the Study Will be Clinically and Radio Graphically Comparison of Two Implant Designs Used to Treat Atrophied Mandible . Implant Design Comparison Will Done for Implant Stability,Peri-implant Soft Tissue Health Changes and Bone Changes .Patients Will be Divided Randomly Into Two Group
Dental Implant Bone Loss, Peri-Implant Health
Not yet recruiting
Effect of Ascorbic Acid-Loaded I-PRF With Partially Demineralized Dentin Graft on Alveolar Ridge Preservation
Alveolar Ridge Preservation Post-Extraction Bone Healing Dental Implant Site Development Tooth Loss, Alveolar Bone Regeneration Following Odontectomy
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.
William Giannobile, DDS, DMedSc principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Alveolar ridge augmentation in people with Dental Implantation, run by William Giannobile at 1 site in United States.
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 7 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: withdrawn, as of the sponsor's last update on 14 Dec 2015. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
horizontal (width) bone gain or loss in millimeters. (time frame: 18 weeks). 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 NCT01154868, which also lists 11 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 14 Dec 2015.