Tooth FracturesNCT02532543

Comparative Volumetric Assessment of Alveolar Ridge Preservation Utilizing Different Bone Grafting Materials

A study testing Allograft, Membrane, Alloplast, Membrane and Xenograft, Membrane in people with Tooth Fractures and Tooth Injuries, run by University of North Carolina, Chapel Hill at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Tooth Fractures, Tooth Injuries, Tooth Diseases
What is being tested?: Allograft, Membrane, Alloplast, Membrane and Xenograft, Membrane
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteUnited States
Study dates: Apr 2016to 12 Feb 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Provision of informed consent
≥ 18 years and ≤ 75 years
Good physical health (ASAI/II)
Extraction of maxillary premolar, canine or incisor, or mandibular premolar and canine required
Teeth adjacent (mesial and distal) to study site must consist of two stable natural teeth with minimal restorations, without signs of periodontal bone loss (> 3 mm) and/or significant soft tissue deficiencies

Who cannot join

Buccal plate dehiscence and/or fenestration >3mm at study site following extraction
Untreated rampant caries and uncontrolled periodontal disease
Inadequate oral hygiene (estimated plaque score >20%)
Smokers using more than 10 cigarettes or equivalent per day
Smokeless tobacco use or e-cigarette use
Compromised physical health and/or uncontrolled or severe systemic diseases including:

Show all 14Show fewer

ASA III/IV Metabolic bone disease History of malignancy History or radiotherapy or chemotherapy for malignancy in the past 5 years History of autoimmune disease Long-term steroidal or antibiotic therapy Uncontrolled diabetes Known alcohol or drug abuse
Systemic or local disease or condition that would compromise post-operative healing
Use of any substance or medication that will influence bone metabolism
Known pregnancy
Unable or unwilling to return for follow-up visits for a period of 6 months
Unlikely to be able to comply with study procedures according to Investigators judgement
Involvement in the planning and conduct of the study
Previous enrollment or randomization of treatment in the present study

Trial locations and contacts

1 site in 1 country.

United States1 site

University of North Carolina School of Dentistry
Chapel Hill, North Carolina, 27599

Other trials in United States

About this study

Official title: Prospective, Comparative Volumetric Assessment of Alveolar Ridge Preservation Utilizing Different Bone Grafting Materials (SYMBIOS CORTICAL-CANCELLOUS GRANULE MIX; SYMBIOS OSTEOGRAF LD-300; OSTEOGRAF/N-300) Following Tooth Extraction

This study is intended to provide statistically robust evidence that Symbios Demineralized Cortical-cancellous granule mix, Symbios OsteoGraf LD-300, and OsteoGraf/N-300 combined with Symbios OsteoShield Collagen Resorbable Membrane can adequately support the alveolus during ridge augmentation procedures, reducing the dimensional changes of both the alveolus and the overlying soft tissues. Additionally, a comparison between each material will be made, providing further evidence of each materials' ability to preserve the alveolus. It is intended to define in objective terms the response of the hard and soft tissues to ridge augmentation.

Conditions: Tooth Fractures, Tooth Injuries, Tooth Diseases
Being tested: Allograft, Membrane, Alloplast, Membrane, Xenograft, Membrane, Membrane
Medical subject headings: Tooth Fractures, Tooth Injuries, Tooth Diseases

What participants receive

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

Allograft, MembraneBiological
Allograft, Membrane- Symbios mineralized cortical-cancellous granule mix, Symbios OsteoShield Collagen Resorbable Membrane
Alloplast, MembraneBiological
Alloplast, Membrane- Symbios OsteoGraf/LD-300, Symbios OsteoShield Collagen Resorbable Membrane
Xenograft, MembraneBiological
Xenograft, Membrane- OsteoGraf/N-300,Symbios OsteoShield Collagen Resorbable Membrane
MembraneBiological
Membrane - Symbios OsteoShield Collagen Resorbable Membrane

Study groups in NCT02532543
Study group	Role	What they receive
Group A- Allograft, Membrane	Active comparator	Symbios mineralized cortical-cancellous granule mix, Symbios OsteoShield Collagen Resorbable Membrane Receives: Biological: Allograft, Membrane
Group B- Alloplast, Membrane	Active comparator	Symbios OsteoGraf/LD-300, Symbios OsteoShield Collagen Resorbable Membrane Receives: Biological: Alloplast, Membrane
Group C- Xenograft, Membrane	Active comparator	OsteoGraf/N-300 , Symbios OsteoShield Collagen Resorbable Membrane Receives: Biological: Xenograft, Membrane
Group D- Membrane	Active comparator	Symbios OsteoShield Collagen Resorbable Membrane Receives: Biological: Membrane

What is being measured

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

Total Mean Change in Bone Volume
The change in bone volume at 3 months following extraction will be calculated using data from DICOM images acquired by Cone Beam Computed Tomography (CBCT) using 3D software
Measured: time of extraction to 3 months post extraction

Secondary outcomes (6)

Mean Osseous Dimensional Changes-Horizontal
The amount of linear (mm) horizontal bone change at 3 months following tooth extraction at a position located 2mm and 4mm vertically away from the height of the buccal plate. Data will be calculated using data from DICOM images acquired by CBCT using 3D software.
Measured: time of extraction to 3 months post extraction
Mean Osseous Dimensional Changes-Vertical
The amount of linear (mm) vertical bone change at 3 months following tooth extraction at a position located mid-buccal, mid-palatal, mesial and distal of the extraction site. Data will be calculated using data from DICOM images acquired by CBCT using 3D software.
Measured: time of extraction to 3 months post extraction
Total Mean Change in Soft Tissue Volume
The change in soft tissue volume at 3 months following tooth extraction will be assessed through the use of 3D scans of patient dental models at two time points following extraction and ridge preservation at 3 months.
Measured: time of extraction to 3 months post extraction
Mean Soft Tissue Dimensional Changes-Horizontal
The amount of linear (mm) horizontal soft tissue change at 3 months following tooth extraction at a position located 2mm and 4mm vertically away from the height of the buccal bone plate. Data will be calculated using data from DICOM images acquired by CBCT and overlaid 3D scans of patient dental models using 3D software.
Measured: time of extraction to 3 months post extraction
Mean Soft Tissue Dimensional Changes-Vertical
The amount of linear (mm) vertical soft tissue change at 3 months following tooth extraction at a position located mid-buccal, mid-palatal, mesial and distal of the extraction site. Data will be calculated using data from 3D scans of patient dental models using 3D software.
Measured: time of extraction to 3 months post extraction
Soft Tissue Dimensional Change at Month 6
The amount of soft tissue change will be assessed through the use of dental casts at two time points following extraction and ridge preservation at 6 months.
Measured: Month 6

Timeline

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

Apr 201612 Feb 2018

First posted25 Aug 2015 (estimated)
Study startApr 2016
Primary completion12 Feb 2018
Study completion12 Feb 2018

Why it stopped: Difficulty in recruitment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (13)Papers the sponsor has linked to this study.
Other trials for Tooth FracturesStudies of the same condition, open and under way.
More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
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: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02532543
Sponsor's protocol ID: 15-1114
Status last verified: Oct 2019
First submitted: 21 Aug 2015
Last updated: 9 Dec 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Schropp L, Wenzel A, Kostopoulos L, Karring T. Bone healing and soft tissue contour changes following single-tooth extraction: a clinical and radiographic 12-month prospective study. Int J Periodontics Restorative Dent. 2003 Aug;23(4):313-23.
PubMed 12956475
Tan WL, Wong TL, Wong MC, Lang NP. A systematic review of post-extractional alveolar hard and soft tissue dimensional changes in humans. Clin Oral Implants Res. 2012 Feb;23 Suppl 5:1-21. doi: 10.1111/j.1600-0501.2011.02375.x.
PubMed 22211303
Araujo MG, Lindhe J. Dimensional ridge alterations following tooth extraction. An experimental study in the dog. J Clin Periodontol. 2005 Feb;32(2):212-8. doi: 10.1111/j.1600-051X.2005.00642.x.
PubMed 15691354
Ten Heggeler JM, Slot DE, Van der Weijden GA. Effect of socket preservation therapies following tooth extraction in non-molar regions in humans: a systematic review. Clin Oral Implants Res. 2011 Aug;22(8):779-88. doi: 10.1111/j.1600-0501.2010.02064.x. Epub 2010 Nov 22.
PubMed 21091540
Darby I, Chen ST, Buser D. Ridge preservation techniques for implant therapy. Int J Oral Maxillofac Implants. 2009;24 Suppl:260-71.
PubMed 19885449
Fienitz T, Schwarz F, Ritter L, Dreiseidler T, Becker J, Rothamel D. Accuracy of cone beam computed tomography in assessing peri-implant bone defect regeneration: a histologically controlled study in dogs. Clin Oral Implants Res. 2012 Jul;23(7):882-7. doi: 10.1111/j.1600-0501.2011.02232.x. Epub 2011 Jun 24.
PubMed 21707753
Veyre-Goulet S, Fortin T, Thierry A. Accuracy of linear measurement provided by cone beam computed tomography to assess bone quantity in the posterior maxilla: a human cadaver study. Clin Implant Dent Relat Res. 2008 Dec;10(4):226-30. doi: 10.1111/j.1708-8208.2008.00083.x. Epub 2008 Apr 1.
PubMed 18384410
Kim TS, Caruso JM, Christensen H, Torabinejad M. A comparison of cone-beam computed tomography and direct measurement in the examination of the mandibular canal and adjacent structures. J Endod. 2010 Jul;36(7):1191-4. doi: 10.1016/j.joen.2010.03.028.
PubMed 20630297
Pertl L, Gashi-Cenkoglu B, Reichmann J, Jakse N, Pertl C. Preoperative assessment of the mandibular canal in implant surgery: comparison of rotational panoramic radiography (OPG), computed tomography (CT) and cone beam computed tomography (CBCT) for preoperative assessment in implant surgery. Eur J Oral Implantol. 2013 Spring;6(1):73-80.
PubMed 23513204
Ganguly R, Ruprecht A, Vincent S, Hellstein J, Timmons S, Qian F. Accuracy of linear measurement in the Galileos cone beam computed tomography under simulated clinical conditions. Dentomaxillofac Radiol. 2011 Jul;40(5):299-305. doi: 10.1259/dmfr/72117593.
PubMed 21697155
Tyndall DA, Price JB, Tetradis S, Ganz SD, Hildebolt C, Scarfe WC; American Academy of Oral and Maxillofacial Radiology. Position statement of the American Academy of Oral and Maxillofacial Radiology on selection criteria for the use of radiology in dental implantology with emphasis on cone beam computed tomography. Oral Surg Oral Med Oral Pathol Oral Radiol. 2012 Jun;113(6):817-26. doi: 10.1016/j.oooo.2012.03.005.
PubMed 22668710
Watters W 3rd, Rethman MP, Hanson NB, Abt E, Anderson PA, Carroll KC, Futrell HC, Garvin K, Glenn SO, Hellstein J, Hewlett A, Kolessar D, Moucha C, O'Donnell RJ, O'Toole JE, Osmon DR, Evans RP, Rinella A, Steinberg MJ, Goldberg M, Ristic H, Boyer K, Sluka P, Martin WR 3rd, Cummins DS, Song S, Woznica A, Gross L; American Academy of Orthopedic Surgeons; American Dental Association. Prevention of Orthopaedic Implant Infection in Patients Undergoing Dental Procedures. J Am Acad Orthop Surg. 2013 Mar;21(3):180-9. doi: 10.5435/JAAOS-21-03-180.
PubMed 23457068
Kurien S, Kattimani VS, Sriram RR, Sriram SK, Rao V K P, Bhupathi A, Bodduru RR, N Patil N. Management of pregnant patient in dentistry. J Int Oral Health. 2013 Feb;5(1):88-97. Epub 2013 Feb 26.
PubMed 24155583

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

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All Tooth Fractures trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective, Comparative Volumetric Assessment of Alveolar Ridge Preservation Utilizing Different Bone Grafting Materials (SYMBIOS CORTICAL-CANCELLOUS GRANULE MIX; SYMBIOS OSTEOGRAF LD-300; OSTEOGRAF/N-300) Following Tooth Extraction
ClinicalTrials.gov ID: NCT02532543
Acronym / sponsor ID: 15-1114
Conditions: Tooth Fractures, Tooth Injuries, Tooth Diseases
Study type: Interventional
Recruitment status: TerminatedReason stopped: Difficulty in recruitment
Enrolment: 16 participants (actual)
Lead sponsor: University of North Carolina, Chapel HillUniversity, hospital or other
Collaborators: Dentsply International
Study start: Apr 2016 (actual)
Primary completion: 12 Feb 2018 (actual)
Study completion: 12 Feb 2018 (actual)
First posted: 25 Aug 2015 (estimated)
Results: Posted 9 Dec 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Group A- Allograft, Membrane	Active comparator	Biological: Allograft, MembraneSymbios mineralized cortical-cancellous granule mix, Symbios OsteoShield Collagen Resorbable Membrane
Group B- Alloplast, Membrane	Active comparator	Biological: Alloplast, MembraneSymbios OsteoGraf/LD-300, Symbios OsteoShield Collagen Resorbable Membrane
Group C- Xenograft, Membrane	Active comparator	Biological: Xenograft, MembraneOsteoGraf/N-300 , Symbios OsteoShield Collagen Resorbable Membrane
Group D- Membrane	Active comparator	Biological: MembraneSymbios OsteoShield Collagen Resorbable Membrane

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Provision of informed consent
≥ 18 years and ≤ 75 years
Good physical health (ASAI/II)
Extraction of maxillary premolar, canine or incisor, or mandibular premolar and canine required
Teeth adjacent (mesial and distal) to study site must consist of two stable natural teeth with minimal restorations, without signs of periodontal bone loss (> 3 mm) and/or significant soft tissue deficiencies

Key exclusion criteria (14 listed)

Buccal plate dehiscence and/or fenestration >3mm at study site following extraction
Untreated rampant caries and uncontrolled periodontal disease
Inadequate oral hygiene (estimated plaque score >20%)
Smokers using more than 10 cigarettes or equivalent per day
Smokeless tobacco use or e-cigarette use

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
Allograft, MembraneAllograft, Membrane- Symbios mineralized cortical-cancellous granule mix, Symbios OsteoShield Collagen Resorbable Membrane	Biological	Group A- Allograft, Membrane
Alloplast, MembraneAlloplast, Membrane- Symbios OsteoGraf/LD-300, Symbios OsteoShield Collagen Resorbable Membrane	Biological	Group B- Alloplast, Membrane
Xenograft, MembraneXenograft, Membrane- OsteoGraf/N-300,Symbios OsteoShield Collagen Resorbable Membrane	Biological	Group C- Xenograft, Membrane
MembraneMembrane - Symbios OsteoShield Collagen Resorbable Membrane	Biological	Group D- Membrane

Primary outcome

Total Mean Change in Bone Volume
Time frame: time of extraction to 3 months post extraction
The change in bone volume at 3 months following extraction will be calculated using data from DICOM images acquired by Cone Beam Computed Tomography (CBCT) using 3D software

6 secondary outcomes

Mean Osseous Dimensional Changes-Horizontal
Time frame: time of extraction to 3 months post extraction
Mean Osseous Dimensional Changes-Vertical
Time frame: time of extraction to 3 months post extraction
Total Mean Change in Soft Tissue Volume
Time frame: time of extraction to 3 months post extraction
Mean Soft Tissue Dimensional Changes-Horizontal
Time frame: time of extraction to 3 months post extraction
Mean Soft Tissue Dimensional Changes-Vertical
Time frame: time of extraction to 3 months post extraction
Soft Tissue Dimensional Change at Month 6
Time frame: Month 6

Results and safety

Results posted to the registry on 9 Dec 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group A- Allograft, Membrane	3	3
Group B- Alloplast, Membrane	4	4
Group C- Xenograft, Membrane	5	4
Group D- Membrane	4	4

Primary outcome: Total Mean Change in Bone Volume

Time frame: time of extraction to 3 months post extraction. Mean (Standard Deviation). Unit: mm^3

Measure	Group A- Allograft, Membrane n = 3	Group B- Alloplast, Membrane n = 4	Group C- Xenograft, Membrane n = 4	Group D- Membrane n = 4
Value	-91.64 (51.97)	-107.47 (52.31)	-77.31 (30.99)	-99.41 (66.00)

Group A- Allograft, Membrane vs Group B- Alloplast, Membrane vs Group C- Xenograft, Membrane vs Group D- Membrane: p = 0.863, ANOVA

Population analysed: One participant was lost to follow up.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the signing of the Informed Consent form until study completion, a total of approximately 3 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group A- Allograft, Membrane	0 of 3 (0%)	0 of 3 (0%)	0 of 3
Group B- Alloplast, Membrane	0 of 4 (0%)	0 of 4 (0%)	0 of 4
Group C- Xenograft, Membrane	0 of 5 (0%)	0 of 5 (0%)	0 of 5
Group D- Membrane	0 of 4 (0%)	0 of 4 (0%)	0 of 4

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 12956475Schropp L, Wenzel A, Kostopoulos L, Karring T. Bone healing and soft tissue contour changes following single-tooth extraction: a clinical and radiographic 12-month prospective study. Int J Periodontics Restorative Dent. 2003 Aug;23(4):313-23.
Background: PubMed 22211303Tan WL, Wong TL, Wong MC, Lang NP. A systematic review of post-extractional alveolar hard and soft tissue dimensional changes in humans. Clin Oral Implants Res. 2012 Feb;23 Suppl 5:1-21. doi: 10.1111/j.1600-0501.2011.02375.x.
Background: PubMed 15691354Araujo MG, Lindhe J. Dimensional ridge alterations following tooth extraction. An experimental study in the dog. J Clin Periodontol. 2005 Feb;32(2):212-8. doi: 10.1111/j.1600-051X.2005.00642.x.
Background: PubMed 21091540Ten Heggeler JM, Slot DE, Van der Weijden GA. Effect of socket preservation therapies following tooth extraction in non-molar regions in humans: a systematic review. Clin Oral Implants Res. 2011 Aug;22(8):779-88. doi: 10.1111/j.1600-0501.2010.02064.x. Epub 2010 Nov 22.
Background: PubMed 19885449Darby I, Chen ST, Buser D. Ridge preservation techniques for implant therapy. Int J Oral Maxillofac Implants. 2009;24 Suppl:260-71.
Background: PubMed 21707753Fienitz T, Schwarz F, Ritter L, Dreiseidler T, Becker J, Rothamel D. Accuracy of cone beam computed tomography in assessing peri-implant bone defect regeneration: a histologically controlled study in dogs. Clin Oral Implants Res. 2012 Jul;23(7):882-7. doi: 10.1111/j.1600-0501.2011.02232.x. Epub 2011 Jun 24.
Background: PubMed 18384410Veyre-Goulet S, Fortin T, Thierry A. Accuracy of linear measurement provided by cone beam computed tomography to assess bone quantity in the posterior maxilla: a human cadaver study. Clin Implant Dent Relat Res. 2008 Dec;10(4):226-30. doi: 10.1111/j.1708-8208.2008.00083.x. Epub 2008 Apr 1.
Background: PubMed 20630297Kim TS, Caruso JM, Christensen H, Torabinejad M. A comparison of cone-beam computed tomography and direct measurement in the examination of the mandibular canal and adjacent structures. J Endod. 2010 Jul;36(7):1191-4. doi: 10.1016/j.joen.2010.03.028.
Background: PubMed 23513204Pertl L, Gashi-Cenkoglu B, Reichmann J, Jakse N, Pertl C. Preoperative assessment of the mandibular canal in implant surgery: comparison of rotational panoramic radiography (OPG), computed tomography (CT) and cone beam computed tomography (CBCT) for preoperative assessment in implant surgery. Eur J Oral Implantol. 2013 Spring;6(1):73-80.
Background: PubMed 21697155Ganguly R, Ruprecht A, Vincent S, Hellstein J, Timmons S, Qian F. Accuracy of linear measurement in the Galileos cone beam computed tomography under simulated clinical conditions. Dentomaxillofac Radiol. 2011 Jul;40(5):299-305. doi: 10.1259/dmfr/72117593.
Background: PubMed 22668710Tyndall DA, Price JB, Tetradis S, Ganz SD, Hildebolt C, Scarfe WC; American Academy of Oral and Maxillofacial Radiology. Position statement of the American Academy of Oral and Maxillofacial Radiology on selection criteria for the use of radiology in dental implantology with emphasis on cone beam computed tomography. Oral Surg Oral Med Oral Pathol Oral Radiol. 2012 Jun;113(6):817-26. doi: 10.1016/j.oooo.2012.03.005.
Background: PubMed 23457068Watters W 3rd, Rethman MP, Hanson NB, Abt E, Anderson PA, Carroll KC, Futrell HC, Garvin K, Glenn SO, Hellstein J, Hewlett A, Kolessar D, Moucha C, O'Donnell RJ, O'Toole JE, Osmon DR, Evans RP, Rinella A, Steinberg MJ, Goldberg M, Ristic H, Boyer K, Sluka P, Martin WR 3rd, Cummins DS, Song S, Woznica A, Gross L; American Academy of Orthopedic Surgeons; American Dental Association. Prevention of Orthopaedic Implant Infection in Patients Undergoing Dental Procedures. J Am Acad Orthop Surg. 2013 Mar;21(3):180-9. doi: 10.5435/JAAOS-21-03-180.
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.

Jonathan Reside, DDS MS principal investigator

Dept. of Periodontology

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 14 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: stopped early, as of the sponsor's last update on 9 Dec 2019. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Total Mean Change in Bone Volume (time frame: time of extraction to 3 months post extraction). 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 NCT02532543, which also lists 13 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 9 Dec 2019.