Atrophy of Edentulous Alveolar RidgeNCT01794806
Efficacy of Socket Grafting for Alveolar Ridge Preservation
A study testing Tooth extraction and grafting with allograft and Tooth extraction in people with Atrophy of Edentulous Alveolar Ridge, run by University of Iowa at 1 site in United States.
Trial summary
The purpose of this study is to clinically and radiographically assess whether the use of a ridge preservation technique significantly minimizes alveolar ridge resorption following tooth extraction. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Atrophy of Edentulous Alveolar Ridge
- What is being tested?
- Tooth extraction and grafting with allograft and Tooth extraction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Oct 2014
- 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
- Age: 18 to 75 years.
- Gender: No restriction.
- Subjects must require a single-rooted tooth extraction (Tooth deemed as periodontally and/or restoratively hopeless), except lower incisors and second premolars.
- Subjects must be able and willing to follow instructions related to the study procedures.
- Subjects must have read, understood and signed an informed consent form.
Who cannot join
- Reported allergy or hypersensitivity to any of the products to be used in the study.
- Severe hematologic disorders, such as hemophilia or leukemia.
- Active severe infectious diseases that may compromise normal healing.
- Liver or kidney dysfunction/failure.
- Currently under cancer treatment or within 18 months from completion of radio- or chemotherapy.
- Subjects who have a long-term history of oral bisphosphonate use (i.e. 10 years or more).
Show all 14Show fewer
- Subjects with a history of IV bisphosphonates.
- Subjects with uncontrolled diabetes.
- Subjects with severe metabolic bone diseases, such as Paget's disease of bone, will be excluded.
- Pregnant women or nursing mothers.
- Smokers: Subjects who have smoked within 6 months of study onset.
- Concomitant medications: Subjects on concomitant drug therapy for systemic conditions that may affect the outcomes of the study will not be included in the study.
- NOTE: Occasional, short-term use (7-14 days) of analgesics or common cold medications is permitted. Use of such medications will be reviewed and recorded by the investigator.
- Any other non-specified reason that from the point of views of the investigators will make a candidate not a suitable subject for the study (e.g. limited mouth opening).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa College of Dentistry - Craniofacial Clinical Research Center
Iowa City, Iowa, 52242
About this study
Official title: Efficacy of Socket Grafting for Alveolar Ridge Preservation: A Randomized Controlled Trial
The purpose of this study is to clinically and radiographically assess whether the use of a ridge preservation technique significantly minimizes alveolar ridge resorption following tooth extraction.
Read the detailed description
Subjects requiring single-rooted tooth extractions and future tooth replacement therapy with implant-supported restorations will be recruited. Subjects will be randomly assigned to either a control (tooth extraction alone) or an experimental group (tooth extraction and ridge preservation using an allograft to fill the alveolar socket covered with a non-absorbable, dense polytetrafluoroethylene membrane [dPTFE]). Clinical linear measurements of the ridge (horizontal and vertical) will be obtained using a tooth-supported stent. Following extraction, primary closure of the socket will not be attempted. Subjects will be re-evaluated at 1 and 4 weeks. Implant placement surgery will be performed at 16 weeks. Clinical measurements will be repeated upon surgical re-entry. Cone beam computed tomographic (CBCT) scans will be obtained at baseline (after tooth extraction) and at 14 weeks (prior to implant placement) to assess alveolar ridge volumetric changes (primary outcome). Secondary outcome measures include changes in bucco-lingual and apico-coronal clinical measurements of the ridge and changes in modified wound healing index changes overtime. The influence of the thickness of the facial and lingual bone of the alveolar ridge and the width of the keratinized tissue on the remodeling of the ridge will be evaluated.
- Conditions
- Atrophy of Edentulous Alveolar Ridge
- Being tested
- Tooth extraction and grafting with allograft, Tooth extraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tooth extraction and grafting with allograftProcedure or surgery
Also called Alveolar socket grafting
Alveolar ridge preservation using a bone grafting material (allograft) and a synthetic dPTFE (dense Polytetrafluoroethylene) barrier membrane
Tooth extractionProcedure or surgery
Minimally traumatic single-rooted tooth extraction
| Study group | Role | What they receive |
|---|---|---|
| Tooth extraction and grafting | Experimental | Tooth extraction and grafting with allograft Receives: Procedure: Tooth extraction and grafting with allograft |
| Tooth extraction | Sham comparator | Tooth extraction Receives: Procedure: Tooth extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alveolar Ridge Volumetric Changes
3D reconstructions using radiographic data obtained at baseline and at 14 weeks after the intervention was utilized to calculate the reduction of bone volume that took place during the healing period in both groups
Measured: Baseline to Week 14 after tooth extraction
Secondary outcomes (2)
Changes in Bucco-lingual Ridge Dimension
Linear ridge width change at the bone crest
Measured: Baseline to Week 14 after tooth extraction
Changes in Apico-coronal Ridge Dimension
Linear ridge height change at the mid-facial aspect of the ridge
Measured: Week 14 after tooth extraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2013 (estimated)
- Study startMar 2013
- Primary completionOct 2014
- Study completionOct 2014
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 (1)Papers the sponsor has linked to this study.
- Other trials for Atrophy of Edentulous Alveolar RidgeStudies of the same condition, open and under way.
- More trials run by University of IowaThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Collaborators
- Osteogenics Biomedical
- Responsible party
- Principal investigator, Gustavo Avila-Ortiz, University of Iowa
- Investigators
- Gustavo Avila-Ortiz, DDS, MS, PhD, Principal investigator, UI College of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01794806
- Sponsor's protocol ID
- 201301766
- Status last verified
- Jul 2017
- First submitted
- 22 Jan 2013
- Last updated
- 17 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Avila-Ortiz G, Gubler M, Romero-Bustillos M, Nicholas CL, Zimmerman MB, Barwacz CA. Efficacy of Alveolar Ridge Preservation: A Randomized Controlled Trial. J Dent Res. 2020 Apr;99(4):402-409. doi: 10.1177/0022034520905660. Epub 2020 Feb 12.
PubMed 32050833
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Socket Grafting for Alveolar Ridge Preservation: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01794806
- Acronym / sponsor ID
- 201301766
- Conditions
- Atrophy of Edentulous Alveolar Ridge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Collaborators
- Osteogenics Biomedical
- Study start
- Mar 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 20 Feb 2013 (estimated)
- Results
- Posted 11 Jul 2017
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 clinically and radiographically assess whether the use of a ridge preservation technique significantly minimizes alveolar ridge resorption following tooth extraction.
Detailed description
Subjects requiring single-rooted tooth extractions and future tooth replacement therapy with implant-supported restorations will be recruited. Subjects will be randomly assigned to either a control (tooth extraction alone) or an experimental group (tooth extraction and ridge preservation using an allograft to fill the alveolar socket covered with a non-absorbable, dense polytetrafluoroethylene membrane [dPTFE]). Clinical linear measurements of the ridge (horizontal and vertical) will be obtained using a tooth-supported stent. Following extraction, primary closure of the socket will not be attempted. Subjects will be re-evaluated at 1 and 4 weeks. Implant placement surgery will be performed at 16 weeks. Clinical measurements will be repeated upon surgical re-entry. Cone beam computed tomographic (CBCT) scans will be obtained at baseline (after tooth extraction) and at 14 weeks (prior to implant placement) to assess alveolar ridge volumetric changes (primary outcome). Secondary outcome measures include changes in bucco-lingual and apico-coronal clinical measurements of the ridge and changes in modified wound healing index changes overtime. The influence of the thickness of the facial and lingual bone of the alveolar ridge and the width of the keratinized tissue on the remodeling of the ridge will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tooth extraction and grafting | Experimental | Procedure: Tooth extraction and grafting with allograftTooth extraction and grafting with allograft |
| Tooth extraction | Sham comparator | Procedure: Tooth extractionTooth extraction |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: 18 to 75 years.
- Gender: No restriction.
- Subjects must require a single-rooted tooth extraction (Tooth deemed as periodontally and/or restoratively hopeless), except lower incisors and second premolars.
- Subjects must be able and willing to follow instructions related to the study procedures.
- Subjects must have read, understood and signed an informed consent form.
Key exclusion criteria (14 listed)
- Reported allergy or hypersensitivity to any of the products to be used in the study.
- Severe hematologic disorders, such as hemophilia or leukemia.
- Active severe infectious diseases that may compromise normal healing.
- Liver or kidney dysfunction/failure.
- Currently under cancer treatment or within 18 months from completion of radio- or chemotherapy.
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 |
|---|---|---|
| Tooth extraction and grafting with allograftAlso: Alveolar socket graftingAlveolar ridge preservation using a bone grafting material (allograft) and a synthetic dPTFE (dense Polytetrafluoroethylene) barrier membrane | Procedure or surgery | Tooth extraction and grafting |
| Tooth extractionMinimally traumatic single-rooted tooth extraction | Procedure or surgery | Tooth extraction |
Primary outcome
Alveolar Ridge Volumetric Changes
Time frame: Baseline to Week 14 after tooth extraction
3D reconstructions using radiographic data obtained at baseline and at 14 weeks after the intervention was utilized to calculate the reduction of bone volume that took place during the healing period in both groups
2 secondary outcomes
Changes in Bucco-lingual Ridge Dimension
Time frame: Baseline to Week 14 after tooth extraction
Changes in Apico-coronal Ridge Dimension
Time frame: Week 14 after tooth extraction
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32050833Avila-Ortiz G, Gubler M, Romero-Bustillos M, Nicholas CL, Zimmerman MB, Barwacz CA. Efficacy of Alveolar Ridge Preservation: A Randomized Controlled Trial. J Dent Res. 2020 Apr;99(4):402-409. doi: 10.1177/0022034520905660. Epub 2020 Feb 12.
Related trials for Atrophy of Edentulous Alveolar Ridge
Active, not recruiting
L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
Alveolar Ridge Resorption After Extraction, Alveolar Bone Loss
Recruiting
Two Bovine Xenografts in Lateral Window Sinus Augmentation With or Without Bone Marrow Blood
Alveolar Bone Loss, Sinus Floor Augmentation
Active, not recruiting
Osseodensification for Narrow Alveolar Ridge Expansion
Osseodensification, Bone Expansion
Recruiting
Crestal Bone Loss Around Narrow Diameter Implants Versus Standard Diameter Implants With Bone Augmentation in Horizontally Deficient Posterior Mandibular Sites.
Horizontal Atrophy of Edentulous Alveolar Ridge
Recruiting
Freeze-dried Bone Allograft vs Autologous Bone Blocks in the Lateral Augmentation of the Jaws
Edentulous Alveolar Ridge, Edentulous Alveolar Ridge Atrophy
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.
Gustavo Avila-Ortiz, DDS, MS, PhD principal investigator
UI College of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tooth extraction and grafting with allograft and Tooth extraction in people with Atrophy of Edentulous Alveolar Ridge, run by University of Iowa 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 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: finished, as of the sponsor's last update on 17 Aug 2017. 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. Some participants in this study may receive a placebo. 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 11 Jul 2017). 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?
Alveolar Ridge Volumetric Changes (time frame: Baseline to Week 14 after tooth 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 NCT01794806, which also lists 1 linked publication.
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 17 Aug 2017.