Missing ToothNCT03302143
Radiographic and the Esthetic Outcome of Two Different Bone Grafting Techniques in Early Implant Placement
A study testing Guided bone regeneration with Bovine Bone Mineral and Guided bone regeneration with freeze dried bone allograft in people with Missing Tooth and Fractured Tooth, run by The University of Texas Health Science Center at San Antonio.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Missing Tooth, Fractured Tooth
- What is being tested?
- Guided bone regeneration with Bovine Bone Mineral and Guided bone regeneration with freeze dried bone allograft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 30 Jul 2013to 15 May 2016
- 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
- The patient is 18 years or older.
- Non-smoker or patient has smoking habit and < 1 pack per day.
- Ability to understand and provide informed consent before starting the study.
- Ability and willingness to comply with all study requirements.
- The patient, if of child-bearing potential, has a negative urine pregnancy test.
- Adequate oral hygiene to allow for implant therapy consistent with standards of care.
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- Adequate primary stability following early implant placement protocols utilizing Straumann Bone Level implants NC 3.3mm or RC 4.1mm in diameter at all available implant lengths.
- One or more teeth in maxilla (11,12,13,14,15,21,22,23,24,25 according to FDI) has been identified as having a hopeless prognosis requiring extraction leading to a single-tooth gap requiring implant placement as determined by clinician.
- Implant site that has a defect and requires bone augmentation. This will be determined by measuring on the CBCT image the available space for the implant and whether or not there is enough bone width where the implant is to be placed.
Who cannot join
- Patient reports current smoking habit > 1 pack per day or tobacco chewing use.
- History of alcoholism or drug abuse within the past 5 years.
- Severe bruxism or clenching habits.
- Patient has significant untreated periodontal disease (grade III or IV), caries, or clinical or radiographic signs of infection within two adjacent tooth positions of implant area.
- History of HIV infection, Hepatitis B or C.
- Patients with a history of systemic disease that precludes standard dental implant therapy.
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- Presence of local inflammation or mucosal diseases such as lichen planus
- Patient history consistent with high risk for subacute bacterial endocarditis
- Current hematological disorder or coumadin (or similar) therapy
- Patient currently undergoing chemotherapy
- Patient history of radiation treatment to the head or neck
- Physical or mental handicaps that would interfere with patient's ability to exercise good oral hygiene on a regular basis
- Pregnant or breastfeeding women
About this study
Official title: A Comparative, Randomized, Prospective, Clinical Study to Evaluate the Facial Bone and Esthetic Outcome of Buccal Augmentation Bone Grafting Techniques in Early (Type 2) Implant Placement
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.
Read the detailed description
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.
- Conditions
- Missing Tooth, Fractured Tooth
- Being tested
- Guided bone regeneration with Bovine Bone Mineral, Guided bone regeneration with freeze dried bone allograft
- Keywords
- Dental Implant, Guided Bone Regeneration, Contour Augmentation
- Medical subject headings
- Anodontia, Tooth Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided bone regeneration with Bovine Bone MineralProcedure or surgery
Guided bone regeneration with Bovine Bone Mineral
Guided bone regeneration with freeze dried bone allograftProcedure or surgery
Guided bone regeneration with freeze dried bone allograft
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Guided bone regeneration with Bovine Bone Mineral Receives: Procedure: Guided bone regeneration with Bovine Bone Mineral |
| Experimental | Experimental | Guided bone regeneration with freeze dried bone allograft Receives: Procedure: Guided bone regeneration with freeze dried bone allograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Facial bone thickness
Facial bone thickness 1 year post-loading at 1, 3, and 5mm from the implant platform
Measured: Measured at 1 year post-loading
Secondary outcomes (5)
Change in facial bone thickness
Change in facial bone thickness between implant placement and 1 year post-loading
Measured: Between implant placement and 1 year post-loading
mPI measurement
Measurement of modified Plaque Index
Measured: Measured at 6 and 12-months post-loading
PD measurement
Measurement of pocket depth
Measured: Measured at 6 and 12-months post-loading
mSBI measurement
Measurement of modified sulcus bleeding index
Measured: Measured at 6 and 12-months post-loading
KM measurement
Measurement of keratinized mucosa
Measured: Measured at 6 and 12-months post-loading
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2017
- Study start30 Jul 2013
- Primary completion15 May 2016
- Study completion15 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Missing ToothStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe 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
- Model description
- A comparative, randomized, prospective, clinical study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03302143
- Sponsor's protocol ID
- HSC20120264H
- Status last verified
- Sep 2017
- First submitted
- 26 Sep 2017
- Last updated
- 4 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative, Randomized, Prospective, Clinical Study to Evaluate the Facial Bone and Esthetic Outcome of Buccal Augmentation Bone Grafting Techniques in Early (Type 2) Implant Placement
- ClinicalTrials.gov ID
- NCT03302143
- Acronym / sponsor ID
- HSC20120264H
- Conditions
- Missing Tooth, Fractured Tooth
- Keywords
- Dental Implant, Guided Bone Regeneration, Contour Augmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- 30 Jul 2013 (actual)
- Primary completion
- 15 May 2016 (actual)
- Study completion
- 15 May 2016 (actual)
- First posted
- 4 Oct 2017 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A comparative, randomized, prospective, clinical study
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Procedure: Guided bone regeneration with Bovine Bone MineralGuided bone regeneration with Bovine Bone Mineral |
| Experimental | Experimental | Procedure: Guided bone regeneration with freeze dried bone allograftGuided bone regeneration with freeze dried bone allograft |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The patient is 18 years or older.
- Non-smoker or patient has smoking habit and < 1 pack per day.
- Ability to understand and provide informed consent before starting the study.
- Ability and willingness to comply with all study requirements.
- The patient, if of child-bearing potential, has a negative urine pregnancy test.
Key exclusion criteria (13 listed)
- Patient reports current smoking habit > 1 pack per day or tobacco chewing use.
- History of alcoholism or drug abuse within the past 5 years.
- Severe bruxism or clenching habits.
- Patient has significant untreated periodontal disease (grade III or IV), caries, or clinical or radiographic signs of infection within two adjacent tooth positions of implant area.
- History of HIV infection, Hepatitis B or C.
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 |
|---|---|---|
| Guided bone regeneration with Bovine Bone MineralGuided bone regeneration with Bovine Bone Mineral | Procedure or surgery | Control |
| Guided bone regeneration with freeze dried bone allograftGuided bone regeneration with freeze dried bone allograft | Procedure or surgery | Experimental |
Primary outcome
Facial bone thickness
Time frame: Measured at 1 year post-loading
Facial bone thickness 1 year post-loading at 1, 3, and 5mm from the implant platform
5 secondary outcomes
Change in facial bone thickness
Time frame: Between implant placement and 1 year post-loading
mPI measurement
Time frame: Measured at 6 and 12-months post-loading
PD measurement
Time frame: Measured at 6 and 12-months post-loading
mSBI measurement
Time frame: Measured at 6 and 12-months post-loading
KM measurement
Time frame: Measured at 6 and 12-months post-loading
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 4 Oct 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Guided bone regeneration with Bovine Bone Mineral and Guided bone regeneration with freeze dried bone allograft in people with Missing Tooth and Fractured Tooth, run by The University of Texas Health Science Center at San Antonio.
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 9 inclusion and 13 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 4 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Facial bone thickness (time frame: Measured at 1 year post-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 4 Oct 2017.