Extraction and Socket Preservation Before Implant Placement Using Freezed Dried Allograft (FDBA) and Platelet-Rich Fibrin in Smokers

King Saud University

Status: Completed

Conditions: A-PRF

Treatments: Biological: platelet rich fibrin

Study type: Interventional

Funder types: Other

Identifiers

NCT05161455

E-21-5999

Details and patient eligibility

About

the investigators aim from this study to evaluate platelet rich fibrin potential to heal the periodontal tissue and to form new native bone in smokers that require socket augmentation following dental extraction and before implant placement.

Materials and Methods: 18 adult smoker patients with 40 extracted sockets were recruited for this study, and the extracted sockets were distributed into four different groups as follows; Group 1- A-PRF alone, Group 2- Factors-enriched bone graft matrix (commonly known as sticky bone) using autologous fibrin glue combined with an FDBA with CGF-Enriched Fibrin Membrane to covered it, Group 3- an FDBA with a crosslinked collagen membrane and Group 4-Resorbable collagen plug (RCP) alone serving as a negative control group.

The patients were randomly grouped into a previously mentioned group, and the socket dimensions were measured four times, immediately after the extraction (0 days), after 10, 21, and 28 days to assess epithelial layer healing.

After six months and before placing the implant fixture, both soft and hard tissue samples will be harvested to be evaluated and compared histologically, also standardized CBCT will be taken before and after extraction to evaluate the amount of mineral content and vital bone formation radiographically.

Enrollment: 40 patients

Sex: All

Ages: 21 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

• Inclusion Criteria:

  • Current smokers
  • have at least one tooth indicated for extraction due to extensive decay, tooth fracture or failed root canal treatment.
  • 21 years of age or older.
  • give a written consent to participate in the trial.
  • have the desire to have an implant restoration for at least one non-restorable tooth
  • indicated for socket preservation procedures and generally healthy with no systematic disease

• Exclusion Criteria:

  • subjects who unable to undergo oral surgery procedures due to a medical condition.
  • women who are pregnant or nursing a child.
  • subjects with dental infection of bone, active periodontal disease and ankylosed teeth.
  • Subjects with following systemic diseases and conditions: Chemotherapy or radiation for the treatment of cancer and arthritis, seriously impaired cardiovascular or pulmonary function, uncontrolled diabetes, auto-immune compromised diseases, kidney or liver disease and history of severe, multiple allergies.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 4 patient groups

A-PRF

Experimental group

Treatment:

Biological: platelet rich fibrin

A-PRF+ allograft bone

Experimental group

Treatment:

Biological: platelet rich fibrin

allograft bone+crosslinked collagen membrane

Active Comparator group

Treatment:

Biological: platelet rich fibrin

collagen plug

Sham Comparator group

Treatment:

Biological: platelet rich fibrin