A 14 Weeks Longitudinal Study to Investigate the Effect of Leukocyte- Platelet Rich Fibrin Plug on the Quality of the Newly Formed Bone in Ridge Preservation Procedure Following a Tooth Extraction. It is a Clinical, Radiographic and Histomorphometric Study.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 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. |
Device: d-PTFE membrane
Following tooth extraction, the socket will be covered with a d-PTFE membrane
Other Names:
|
| Experimental: 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. |
Biological: 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
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Univerisity of Kentucky College of Dentistry | Lexington | Kentucky | United States | 40536 |
Sponsors and Collaborators
- Firas Al Yafi
Investigators
- Principal Investigator: Mhdfiras Al Yafi, DDS, University of Kentucky College of Dentistry
Study Documents (Full-Text)
More Information
Publications
None provided.- 17-0815-F2L
Study Results
Participant Flow
| Recruitment Details | All patients were recruited from the University of Kentucky College of Dentistry clinics between Mar 2018 and Dec 2019. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Control Group | Test Group |
|---|---|---|
| Arm/Group Description | 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 | 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 |
| Period Title: Overall Study | ||
| STARTED | 12 | 15 |
| COMPLETED | 11 | 11 |
| NOT COMPLETED | 1 | 4 |
Baseline Characteristics
| Arm/Group Title | Control Group | Test Group | Total |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | Total of all reporting groups |
| Overall Participants | 12 | 15 | 27 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
3
25%
|
3
20%
|
6
22.2%
|
| >=65 years |
9
75%
|
12
80%
|
21
77.8%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
5
41.7%
|
8
53.3%
|
13
48.1%
|
| Male |
7
58.3%
|
7
46.7%
|
14
51.9%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
| Not Hispanic or Latino |
12
100%
|
15
100%
|
27
100%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
2
16.7%
|
1
6.7%
|
3
11.1%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
1
8.3%
|
1
6.7%
|
2
7.4%
|
| White |
9
75%
|
13
86.7%
|
22
81.5%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
12
100%
|
15
100%
|
27
100%
|
Outcome Measures
| Title | Quality of the Newly Formed Bone |
|---|---|
| Description | 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). |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Control Group | Test Group |
|---|---|---|
| Arm/Group Description | 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 | 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 |
| Measure Participants | 11 | 11 |
| Mean (Standard Deviation) [Percentage of newly formed bone] |
24.14
(16.26)
|
19.12
(10.57)
|
| Title | Dimensional Changes of the Alveolar Ridge (Ridge Width) |
|---|---|
| Description | 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Control Group | Test Group |
|---|---|---|
| Arm/Group Description | 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 | 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 |
| Measure Participants | 11 | 11 |
| Mean (Standard Deviation) [mm] |
0.81
(0.59)
|
1.22
(0.97)
|
Adverse Events
| Time Frame | Adverse event data collection was performed over 14 weeks for each patient, The patient's visits included: • Baseline visit. • Week-one visit. • Week-four visit. • Week-twelve visit. • Week-fourteen visit. All procedures described above were standard of care except for bone core biopsy which was research related. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Subjects were monitored for any adverse reactions throughout the study. All adverse events were managed and documented by the principal investigator. | |||
| Arm/Group Title | Control Group | Test Group | ||
| Arm/Group Description | 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 | 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 | ||
All Cause Mortality |
||||
| Control Group | Test Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/12 (0%) | 0/15 (0%) | ||
Serious Adverse Events |
||||
| Control Group | Test Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/12 (0%) | 0/15 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Control Group | Test Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/12 (0%) | 0/15 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Ridge Preservation with Leukocyte Platelet Rich Fibrin: A Clinical, Radiographic, and Histomorphomet |
|---|---|
| Organization | University of Kentucky |
| Phone | 8593236193 |
| firasayafi@uky.edu |
- 17-0815-F2L