Alveolar Ridge Preservation, Tooth Extraction
Conditions
Keywords
Platelet-Rich Fibrin, high-density polytetrafluoroethylene membrane
Brief summary
This 14 weeks longitudinal study will be conducted from March 2018 to June 2020, with a 40 participants. No subjects has received placebo medication at any point in the research procedures. Null hypothesis: The use of L-PRF plug, in combination with non-resorbable, open barrier membrane technique to fill the extraction sockets will have no effect on the quality of the newly formed bone nor on the dimensional changes of the ridge, compared to non-resorbable, open barrier membrane technique with natural blood clot.
Detailed description
This 14 weeks longitudinal study was conducted from March 2018 to June 2020, with a 27 participants. No subjects has received placebo medication at any point in the research procedures. The proposed sample population has been recruited from the patient population of the University of Kentucky College of Dentistry clinics and the patient must have had an unsalvageable tooth that was planned for extraction and delayed implant placement and was assigned into a control group and a test group by chance. Fifteen extraction socket sites of the test group were filled with autogenous L-PRF Plug (Intralock) and d-PTFE membrane (Cytoplast) was laid on the top to seal the extraction socket. In the control group, d-PTFE membrane (Cytoplast) was laid on the top of twelve extraction sockets to allow natural blood clot formation in the extraction socket. The primary aim is to assess the quality of the newly formed bone at 14 weeks the time of implant placement by comparing the percentage of new vital bone in the histomorphometric analysis. The second aim was to assess the horizontal and vertical changes of the residual bony ridge using Cone Bean Computerized Tomography (CBCT) analysis at baseline immediately after tooth extraction at 12 weeks of healing. Null hypothesis: The use of L-PRF plug, in combination with non-resorbable, open barrier membrane technique to fill the extraction sockets will have no effect on the quality of the newly formed bone nor on the dimensional changes of the ridge, compared to non-resorbable, open barrier membrane technique with natural blood clot.
Interventions
BIOLOGICALLeukocyte platelet rich fibrin plug + d-PTFE membrane
Following tooth extraction, an autologous leukocyte platelet rich fibrin plug will be placed in the socket and covered with a d-PTFE membrane
DEVICEd-PTFE membrane
Following tooth extraction, the socket will be covered with a d-PTFE membrane
Sponsors
Firas Al Yafi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* The subject must have an unsalvageable tooth that is planned for extraction and delayed implant placement. * The tooth should be free of acute odontogenic infections. * Extraction sockets with minimal to moderate bony defect.
Exclusion criteria
* Any patient who is planned for full mouth extraction. * Heavy smoker (more than 10 cigarettes a day). * History of malignancy, chemotherapy, radiation therapy. * Immunosuppressive disease. * Uncontrolled systemic disease. * Any contraindications to surgical procedures. * Females who are pregnant or breastfeeding. * For multi-rooted teeth, if the most coronal part of the interradicular septum is less than 5 mm below the crest of the bone.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of the Newly Formed Bone | The bone sample was harvested at 14 weeks from the baseline visit (extraction of tooth). | Histomorphometric analysis will be performed on a bone core sample harvested at the time of implant placement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dimensional Changes of the Alveolar Ridge (Ridge Width) | The baseline CBCT after tooth extraction and 12 weeks CBCT after extraction. | Two Cone Bean Computerized Tomography (CBCT) measurements were compared to perform the analysis. |
Countries
United States
Participant flow
Recruitment details
All patients were recruited from the University of Kentucky College of Dentistry clinics between Mar 2018 and Dec 2019.
Participants by arm
| Arm | Count |
|---|---|
| Control Group Under the effect of local anesthetic tooth will be extracted then a d-PTFE membrane will be used to cover the socket without any bone graft material to preserve the ridge.
d-PTFE membrane: Following tooth extraction, the socket will be covered with a d-PTFE membrane | 12 |
| Test Group Under the effect of local anesthetic tooth extraction will be followed by the collection of about 50 ml of the patient's venous blood, then without adding any anticougulant the blood will be spun to make a plug. The Leukocyte platelet rich fibrin plug + d-PTFE membrane will be used to preserve the ridge.
Leukocyte platelet rich fibrin plug + d-PTFE membrane: Following tooth extraction, an autologous leukocyte platelet rich fibrin plug will be placed in the socket and covered with a d-PTFE membrane | 15 |
| Total | 27 |
Baseline characteristics
| Characteristic | Control Group | Test Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 9 Participants | 12 Participants | 21 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 3 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 15 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 13 Participants | 22 Participants |
| Region of Enrollment United States | 12 participants | 15 participants | 27 participants |
| Sex: Female, Male Female | 5 Participants | 8 Participants | 13 Participants |
| Sex: Female, Male Male | 7 Participants | 7 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 15 |
| other Total, other adverse events | 0 / 12 | 0 / 15 |
| serious Total, serious adverse events | 0 / 12 | 0 / 15 |
Outcome results
Primary
Quality of the Newly Formed Bone
Histomorphometric analysis will be performed on a bone core sample harvested at the time of implant placement.
Time frame: The bone sample was harvested at 14 weeks from the baseline visit (extraction of tooth).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Quality of the Newly Formed Bone | 24.14 Percentage of newly formed bone | Standard Deviation 16.26 |
| Test Group | Quality of the Newly Formed Bone | 19.12 Percentage of newly formed bone | Standard Deviation 10.57 |
Secondary
Dimensional Changes of the Alveolar Ridge (Ridge Width)
Two Cone Bean Computerized Tomography (CBCT) measurements were compared to perform the analysis.
Time frame: The baseline CBCT after tooth extraction and 12 weeks CBCT after extraction.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Dimensional Changes of the Alveolar Ridge (Ridge Width) | 0.81 mm | Standard Deviation 0.59 |
| Test Group | Dimensional Changes of the Alveolar Ridge (Ridge Width) | 1.22 mm | Standard Deviation 0.97 |