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Completed

NCT Number: NCT03487718

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.

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Univerisity of Kentucky College of Dentistry

Lexington, Kentucky, 40536, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Leukocyte platelet rich fibrin plug + d-PTFE membrane

Biological

Following tooth extraction, an autologous leukocyte platelet rich fibrin plug will be placed in the socket and covered with a d-PTFE membrane

d-PTFE membrane

Device

Following tooth extraction, the socket will be covered with a d-PTFE membrane

Other names: Cytoplast

Primary outcomes

  1. Quality of the Newly Formed Bone

    Time frame: 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 outcomes

  1. Dimensional Changes of the Alveolar Ridge (Ridge Width)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Firas Al Yafi

Other

Registry information

Official study title

Ridge Preservation With Leukocyte Platelet Rich Fibrin: A Clinical, Radiographic, and Histomorphometric Study.

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Apr 4, 2018
Registry last updated
May 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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