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

S

Saint-Joseph University

Status

Completed

Conditions

Post Extraction Alveolar Bone Resorption
Ridge Preservation

Treatments

Procedure: Socket preservation

Study type

Interventional

Funder types

Other

Identifiers

NCT05889377
XFMD218

Details and patient eligibility

About

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.

Enrollment

80 patients

Sex

All

Ages

18 to 62 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. Patients will require single tooth extraction and subsequent implant rehabilitation.
  2. Patients over 18 years of age.
  3. Patients willing to comply with the study requirements (signed consent form)
  4. Good oral hygiene and no signs of active periodontal infection
  5. No compromising medical status
  6. < 10 cigarettes smoking per day

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

80 participants in 4 patient groups

Bovine Bone
Experimental group
Treatment:
Procedure: Socket preservation
Platelet Rich Fibrin
Experimental group
Treatment:
Procedure: Socket preservation
Bovine Bone + PRF
Experimental group
Treatment:
Procedure: Socket preservation
Control
No Intervention group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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