N/A
Completed N=27
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.
Alveolar Ridge Preservation · Tooth Extraction
Source: ClinicalTrials.gov NCT03487718 ↗
Enrolled (actual)
27
Serious AEs
0.0%
Results posted
May 2021
Primary outcomePrimary: Quality of the Newly Formed Bone — 24.14; 19.12 Percentage of newly formed bone
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Quality of the Newly Formed Bone |
24.14; 19.12 | — |
| SECONDARY Dimensional Changes of the Alveolar Ridge (Ridge Width) |
0.81; 1.22 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT03487718). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.