- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01794806
Efficacy of Socket Grafting for Alveolar Ridge Preservation
July 8, 2017 updated by: Gustavo Avila-Ortiz, University of Iowa
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
59
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Iowa
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Iowa City, Iowa, United States, 52242
- University of Iowa College of Dentistry - Craniofacial Clinical Research Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tooth extraction and grafting
Tooth extraction and grafting with allograft
|
Alveolar ridge preservation using a bone grafting material (allograft) and a synthetic dPTFE (dense Polytetrafluoroethylene) barrier membrane
Other Names:
|
Sham Comparator: Tooth extraction
|
Minimally traumatic single-rooted tooth extraction
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Baseline to Week 14 after tooth extraction
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Bucco-lingual Ridge Dimension
Time Frame: Baseline to Week 14 after tooth extraction
|
Linear ridge width change at the bone crest
|
Baseline to Week 14 after tooth extraction
|
Changes in Apico-coronal Ridge Dimension
Time Frame: Week 14 after tooth extraction
|
Linear ridge height change at the mid-facial aspect of the ridge
|
Week 14 after tooth extraction
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Gustavo Avila-Ortiz, DDS, MS, PhD, UI College of Dentistry
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2013
Primary Completion (Actual)
October 1, 2014
Study Completion (Actual)
October 1, 2014
Study Registration Dates
First Submitted
January 22, 2013
First Submitted That Met QC Criteria
February 19, 2013
First Posted (Estimate)
February 20, 2013
Study Record Updates
Last Update Posted (Actual)
August 17, 2017
Last Update Submitted That Met QC Criteria
July 8, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201301766
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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