An interventional study of Guided bone regeneration with Bovine Bone Mineral and Guided bone regeneration with freeze dried bone allograft in Missing Tooth and Fractured Tooth, sponsored by The University of Texas Health Science Center at San Antonio. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-04.
Sponsored by The University of Texas Health Science Center at San Antonio · Not applicable, Interventional, and Treatment
Total of 48 subjects were randomly assigned to treatment groups:
UT Health Science Center at San Antonio Chi Mei Medical Center, Tainan, Taiwan
Patients require a maxillary non-molar extraction site that is planned to be replaced by a dental implant and crown. This includes Straumann BL SLActive: Narrow (3.3mm) \& Regular (4.1mm) Crossfit implants in all available lengths.
Patients were randomly selected to receive either FDBA (test) or Autogenous bone + DBBM (control/standard) for contour augmentation.
This comparative, randomized, prospective clinical study is designed to compare clinical outcomes and facial bone height and thickness of two different bone grafting techniques after augmentation in (Type 2) early implant placement.
Human subjects who could potentially qualify with the said inclusion criteria will be evaluated and screened. 24 human subjects who qualify for the procedure will have a thorough evaluation performed after obtaining consent from the patient. All subjects will require extraction of maxillary teeth (incisors, canines, premolars), followed by early implant placement of the missing teeth after 4 to 8 weeks extraction.
There will be two subject groups in this study in which the 24 human subjects in will randomly be placed by selecting the number "1" or "2" from a hat. 24 human subjects will be divided into two groups including 12 subjects using control group design and 12 subjects using test group design. 12 subjects will be placed randomly into Group 1 and will undergo the flapless extraction and early implant placement with GBR procedure using the control group design. 12 subjects will be placed randomly into Group 2 and will undergo the flapless extraction and early implant placement with GBR procedure using the test group design.
During the implant placement visit after 4 to 8 weeks of extraction, patient will be asked to select a number from a hat. If the number showed "1" as a control group, autograft , BBM and collagen membrane will be used as GBR materials after implant placement. If the number showed "2" as a test group, FDBA and collagen membrane will be used as GBR materials after implant placement.
Extraction sites will include maxillary teeth (11,12,13,14,15,21,22,23,24,25 according to FDI) having intact adjacent teeth. Implants placed for this study will have a SLActive surface, bone level design, Straumann NC 3.3mm or RC 4.1mm in diameter at all available implant lengths.
Control group: early implant placement with autograft plus BBM (Bio-Oss, Geistlich Pharm AG, Wolhausen, Switzerland) plus two layers of collagen membrane (BioGide®).
Test group: early implant placement with FDBA (Straumann Allograft GC®) plus two layers of collagen membrane (BioGide®).
These procedures will follow the guidelines as described by Buser et al. (2008). Implant placements will follow standard protocols utilizing tapping and placement with the hand ratchet.
A CBCT radiograph will be made during the screening visit to determine eligibility for the study and immediately following implant placement with GBR procedure to provide facial bone height and thickness measurements. The second CBCT procedure is not typically a standard of care procedure. After 12 months post loading healing time, the patient will receive another CBCT. This CBCT is also not a standard of care procedure but can accurately assess the amount of facial bone height and thickness maintained during the follow-up period.
37 studies on the registry are indexed under Tooth Fractures; 9 are open to participants now.
This study's enrollment of 48 is above the median of 40 across 33 interventional studies indexed under Tooth Fractures.
Browse Tooth Fractures studies →The University of Texas Health Science Center at San Antonio is the lead sponsor of 445 studies on the registry; 89 are open to participants now.
Of its 65 completed or terminated interventional studies of FDA-regulated products, 35 (54%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Guided bone regeneration with Bovine Bone Mineral
Procedure: Guided bone regeneration with Bovine Bone Mineral
Guided bone regeneration with freeze dried bone allograft
Procedure: Guided bone regeneration with freeze dried bone allograft
Guided bone regeneration with Bovine Bone Mineral
Guided bone regeneration with freeze dried bone allograft
Facial bone thickness
Facial bone thickness 1 year post-loading at 1, 3, and 5mm from the implant platform
Time frame: Measured at 1 year post-loading
Change in facial bone thickness
Change in facial bone thickness between implant placement and 1 year post-loading
Time frame: Between implant placement and 1 year post-loading
mPI measurement
Measurement of modified Plaque Index
Time frame: Measured at 6 and 12-months post-loading
PD measurement
Measurement of pocket depth
Time frame: Measured at 6 and 12-months post-loading
mSBI measurement
Measurement of modified sulcus bleeding index
Time frame: Measured at 6 and 12-months post-loading
KM measurement
Measurement of keratinized mucosa
Time frame: Measured at 6 and 12-months post-loading
No study locations are listed for this record.
Ran from Jul 2013 to primary completion in May 2016, 33 months.
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This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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The University of Texas Health Science Center at San Antonio →