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Completed

NCT Number: NCT05889377

Socket Preservation Technique Using Bovine Bone, Platelet Rich Fibrin Or A Combination Of Both: A Clinical, Radiographic And Histological Assesment At 4 Months

Post extraction alveolar bone resorption is one of the main challenges that face oral implantologists in their daily surgical practice (1). To palliate to post-extraction resorption, advanced bone grafting and regeneration techniques have been described (2). However, these procedures, although well documented and validated, still have relatively high complication rates and patient morbidity, in addition to the elevated cost and duration of treatment (3). Socket preservation is a very useful technique in order to counter post extraction resorption issues, therefore eliminating the need for future complicated and delicate regeneration procedures (4). Many biomaterials were proposed for socket preservation such as allografts and bovine hydroxyapatite (5). Recently autologous platelet concentrates such as Platelet Rich Fibrin PRF were described as a potential socket filler material (6).

In the proposed protocol, fresh extraction sockets will be either grafted by a bovine bone substitute, a PRF plug or a mixture of both. Sockets will then be clinically and radiographically monitored over time to assess three-dimensional soft and hard tissue stability. Bone quality will be histologically examined at 6 months implant placement. A no graft group will serve as control.

The results of this study may be of major importance since they could give an objective idea of the most efficient socket preservation technique, thus offering simple and secure oral rehabilitation solutions for both patient and practitioner.

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Key information

Age range

18 year–62 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saint Joseph University

Beirut, Lebanon

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients will require single tooth extraction and subsequent implant rehabilitation.
  • Patients over 18 years of age.
  • Patients willing to comply with the study requirements (signed consent form)
  • Good oral hygiene and no signs of active periodontal infection
  • No compromising medical status
  • < 10 cigarettes smoking per day

Exclusion criteria

  • acute myocardial infarction within the last two months;
  • Uncontrolled coagulation disorders;
  • uncontrolled diabetes (HBA1c> 7.5);
  • radiation therapy to the head \\ neck region in the last 24 months;
  • immunocompromised patients, HIV positive or receiving chemotherapy in the last five years;
  • past or present treatment with intravenous bisphosphonates;
  • psychological or psychiatric problems;
  • abuse of alcohol or drugs;

Treatment and study plan

Socket preservation

Procedure

Socket preservation will be done after tooth extraction. For each group we will use a bone substitute.

Primary outcomes

  1. Hard tissue change by measuring bone profil retraction between 0,4 and 12 months using 3D slicer software

    Time frame: 4 and 12 months

    Comparison of the bone profile change by CBCT dicom files superimposition at different time frame

  2. Soft tissue change by measuring gingival retraction between 0,4 and 12 months using 3D slicer sftware

    Time frame: 4 and 12 months

    Comparison of the soft tissue profile change by STL files superimposition at different time frame

Sponsors and collaborators

Lead sponsor

Saint-Joseph University

Other

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jun 5, 2023
Registry last updated
May 16, 2025

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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