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NCT Number: NCT05161455

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

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.

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Key information

Conditions

A-PRF

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King Saud University

Riyadh, 12211, Saudi Arabia

Who can participate

Healthy volunteers accepted: Yes

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

  • 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.

Treatment and study plan

Platelet rich fibrin

Biological

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

Primary outcomes

  1. soft tissue healing and migration.

    Time frame: 28 days

    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.

  2. bone height after ridge preservation.

    Time frame: 6 months

    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.

  3. bone width after ridge preservation.

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

King Saud University

Other

Registry information

Official study title

Extraction and Socket Preservation Before Implant Placement Using Freezed Dried Allograft (FDBA) and Platelet-Rich Fibrin in Smokers. A Single Blinded Randomized Controlled Clinical Trial

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 17, 2021
Registry last updated
May 12, 2023

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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