Clinical trial NCT05161455: Extraction and Socket Preservation Before Implant Placement Using Freezed Dried Allograft (FDBA) and Platelet-Rich Fibrin in Smokers
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: A-PRF
Lead sponsor: King Saud University
Sponsor class: OTHER
First posted: 2021-12-17
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: soft tissue healing and migration.
timeFrame: 28 days
measure: bone height after ridge preservation.
timeFrame: 6 months
measure: bone width after ridge preservation.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Saud University
Study officials:
References: