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

NCT05161455 | Completed DMC

• 1 other identifier: E-21-5999
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

A-PRF

Outcome Measures

Primary Outcomes (3)

• soft tissue healing and migration.

  In all groups, the buccolingual and mesiodistal dimensions at the osseous crest of the extraction socket will be measured at the midpoints immediately after extraction with a University of Michigan O Probe with Williams marking (Hu-Friedy® Mfg Chicago, IL, USA) at 0, 10, 21, and 28 days.

  28 days

• bone height after ridge preservation.

  two different measurements shall be taken at baseline and after 6 months using Cone-beam computed tomography to asess vertical resorption measured by mean difference in length of socket.

  6 months

• bone width after ridge preservation.

  two different measurements shall be taken at baseline and after 6 months using Cone-beam computed tomography to asess the mean width ridge difference between outer border of buccal and lingual cortical plate at Socket depth at 1, 3,5 mm.

  6 months

Study Arms (4)

A-PRF

EXPERIMENTAL

Biological: platelet rich fibrin

A-PRF+ allograft bone

EXPERIMENTAL

Biological: platelet rich fibrin

allograft bone+crosslinked collagen membrane

ACTIVE COMPARATOR

Biological: platelet rich fibrin

collagen plug

SHAM COMPARATOR

Biological: platelet rich fibrin

Interventions

platelet rich fibrin BIOLOGICAL

we would like to measure the effect of PRF on soft and hard tissue healing

A-PRF; A-PRF+ allograft bone; allograft bone+crosslinked collagen membrane; collagen plug

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Current smokers
• have at least one tooth indicated for extraction due to extensive decay, tooth fracture or failed root canal treatment.
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Saud University: lead

Study Sites (1)

King Saud University

Riyadh, 12211, Saudi Arabia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor, PHD student

Study Record Dates

• First Submitted: November 12, 2021
• First Posted: December 17, 2021
• Study Start: June 7, 2021
• Primary Completion: March 20, 2023
• Study Completion: May 2, 2023
• Last Updated: May 12, 2023

Record last verified: 2023-05

Locations

SA (1)