Loss of Teeth Due to Extraction
Conditions
Brief summary
Following tooth extraction ridge preservation procedure have been suggested to limit bone resorptive dimensional changes to facilitate prospective implant placement. While this is particularly true for anterior teeth, no evidence is available to establish clinical guidelines in posterior sites, i.e. following molar extraction. This research project will answer the following question: What are the dimensional changes of the hard and soft tissues encountered following molar extractions with and without ridge preservation?
Interventions
PROCEDURERidge preservation
Ridge preservation is a procedure which consists in grafting the tooth extraction socket with a bone grafting material and cover the site with a membrane to protect the site.
Sponsors
Osteogenics Biomedical
The University of Texas Health Science Center at San Antonio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients will be included in this study if they qualify the following inclusion criteria: * One molar tooth that has been identified by dental faculty as requiring a single tooth extraction * A dental implant is indicated and treatment planned to replace the missing molar tooth * Have adequate restorative space for a dental implant-retained restoration * Have at least 10mm of alveolar bone height, without impinging on the maxillary sinus or inferior alveolar canal.
Exclusion criteria
* Obvious exclusions are patients who do not meet all the inclusion criteria or who will not cooperate with the follow-up schedule. * Patients will not be entered who are mentally incompetent, prisoners, or pregnant. * Pregnant women or women intending to become pregnant during the study period. As standard practice prior to dental surgery, females of child-bearing age are asked verbally if there is any possibility that they are pregnant. If not, we proceed with surgery and no pregnancy test is done. If the woman states that there is a possibility that she is pregnant, we do a urine pregnancy test to rule pregnancy in or out. So use of the urine pregnancy test is only done if she says she may be pregnant. \[If needed: An over-the-counter urine pregnancy test will be provided to female subjects in the graduate periodontics clinic of UTHSCSA. Patients will be allowed access to a private restroom and the results of the tests will be read by one of the named investigators. Only those with a negative pre-operative pregnancy test will be eligible for the study.\] Female patients who have undergone a hysterectomy, tubal ligation or menopause will be excluded from pregnancy testing. * Patients who become pregnant during the study will be withdrawn and standard care will be delivered. * Clinical and/or radiographic determinations which will preclude inclusion in this study are: * Active localized or systemic infection other than periodontitis. * Untreated periodontal diseases * Inadequate bone dimensions or restorative space dimensions to place a dental implant * Presence of a disease entity, medical condition or therapeutic regimen which decreases probability of soft tissue and bony healing, e.g., poorly controlled diabetes, chemotherapeutic and immunosuppressive agents, or autoimmune diseases. * Positive medical history of endocarditis following oral or dental surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic Bone Changes | 3 months after tooth extraction | The width and the height of the alveolar ridge will be measured (in mm) on the initial (i.e. following tooth extraction) Cone Beam CT and on the CBCT taken prior to implant placement (i.e. 3 months after tooth extraction) |
Participant flow
Recruitment details
Location: Graduate Periodontics clinic at the University of Texas Health Science Center at San Antonio (UTHSCSA), San Antonio, Texas Date: January 2014 to May 2015
Participants by arm
| Arm | Count |
|---|---|
| Ridge Preservation The molar extraction socket is grafted with FDA approved materials, which includes a bone graft material derived from human donors (enCore®, Osteogenics biomedical, Lubbock, TX) and a membrane (like a thin sheet of paper) covering the grafted extraction socket. The membrane used will need to be removed at a later point since it is non-resorbable (it will not dissolve by itself). This membrane is made of dense polytetrafluoroethylene (dPTFE) (Cytoplast™, Osteogenics biomedical, Lubbock, TX). The procedure is called Ridge preservation
Ridge preservation: Ridge preservation is a procedure which consists in grafting the tooth extraction socket with a bone grafting material and cover the site with a membrane to protect the site. | 20 |
| No Ridge Preservation The molar extraction socket is left to heal by itself without any grafting material or membrane, i.e. Spontaneous Healing (No ridge preservation is performed)
Ridge preservation: Ridge preservation is a procedure which consists in grafting the tooth extraction socket with a bone grafting material and cover the site with a membrane to protect the site. | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Ridge Preservation | No Ridge Preservation | Total |
|---|---|---|---|
| Age, Continuous | 54.1 Years STANDARD_DEVIATION 11.5 | 53.3 Years STANDARD_DEVIATION 10.7 | 53.6 Years STANDARD_DEVIATION 11.6 |
| Region of Enrollment United States | 20 Participants | 20 Participants | 40 Participants |
| Sex: Female, Male Female | 7 Participants | 7 Participants | 14 Participants |
| Sex: Female, Male Male | 13 Participants | 13 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Radiographic Bone Changes
The width and the height of the alveolar ridge will be measured (in mm) on the initial (i.e. following tooth extraction) Cone Beam CT and on the CBCT taken prior to implant placement (i.e. 3 months after tooth extraction)
Time frame: 3 months after tooth extraction
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ridge Preservation | Radiographic Bone Changes | Bone height change | -1.12 millimeter | Standard Error 1.6 |
| Ridge Preservation | Radiographic Bone Changes | Bone width change | -1.16 millimeter | Standard Error 1.97 |
| No Ridge Preservation | Radiographic Bone Changes | Bone height change | -2.60 millimeter | Standard Error 2.06 |
| No Ridge Preservation | Radiographic Bone Changes | Bone width change | -.158 millimeter | Standard Error 2.23 |