Atrophy of Edentulous Alveolar Ridge
Conditions
Brief 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.
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.
Interventions
PROCEDURETooth extraction and grafting with allograft
Alveolar ridge preservation using a bone grafting material (allograft) and a synthetic dPTFE (dense Polytetrafluoroethylene) barrier membrane
PROCEDURETooth extraction
Minimally traumatic single-rooted tooth extraction
Sponsors
Osteogenics Biomedical
University of Iowa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Alveolar Ridge Volumetric Changes | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Bucco-lingual Ridge Dimension | Baseline to Week 14 after tooth extraction | Linear ridge width change at the bone crest |
| Changes in Apico-coronal Ridge Dimension | Week 14 after tooth extraction | Linear ridge height change at the mid-facial aspect of the ridge |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tooth Extraction and Grafting Tooth extraction and grafting with allograft
Tooth extraction and grafting with allograft: Alveolar ridge preservation using a bone grafting material (allograft) and a synthetic dPTFE (dense Polytetrafluoroethylene) barrier membrane | 31 |
| Tooth Extraction Tooth extraction
Tooth extraction: Minimally traumatic single-rooted tooth extraction | 28 |
| Total | 59 |
Baseline characteristics
| Characteristic | Tooth Extraction | Tooth Extraction and Grafting | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 8 Participants | 15 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants | 23 Participants | 44 Participants |
| Age, Continuous | 57.24 years STANDARD_DEVIATION 11.82 | 58.46 years STANDARD_DEVIATION 12.37 | 57.84 years STANDARD_DEVIATION 11.99 |
| Region of Enrollment United States | 28 participants | 31 participants | 59 participants |
| Sex: Female, Male Female | 14 Participants | 17 Participants | 31 Participants |
| Sex: Female, Male Male | 14 Participants | 14 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 28 |
| other Total, other adverse events | 0 / 31 | 2 / 28 |
| serious Total, serious adverse events | 0 / 31 | 0 / 28 |
Outcome results
Primary
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
Time frame: Baseline to Week 14 after tooth extraction
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tooth Extraction and Grafting | Alveolar Ridge Volumetric Changes | -8.36 percentage of volume change | Standard Deviation 3.81 |
| Tooth Extraction | Alveolar Ridge Volumetric Changes | -15.83 percentage of volume change | Standard Deviation 4.48 |
Secondary
Changes in Apico-coronal Ridge Dimension
Linear ridge height change at the mid-facial aspect of the ridge
Time frame: Week 14 after tooth extraction
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tooth Extraction and Grafting | Changes in Apico-coronal Ridge Dimension | -0.61 millimeters |
| Tooth Extraction | Changes in Apico-coronal Ridge Dimension | -1.17 millimeters |
Secondary
Changes in Bucco-lingual Ridge Dimension
Linear ridge width change at the bone crest
Time frame: Baseline to Week 14 after tooth extraction
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Tooth Extraction and Grafting | Changes in Bucco-lingual Ridge Dimension | -1.0 millimeters |
| Tooth Extraction | Changes in Bucco-lingual Ridge Dimension | -1.8 millimeters |