A-PRFNCT05161455
Extraction and Socket Preservation Before Implant Placement Using Freezed Dried Allograft (FDBA) and Platelet-Rich Fibrin in Smokers
A study testing platelet rich fibrin in people with A-PRF, run by King Saud University at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- A-PRF
- What is being tested?
- platelet rich fibrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 7 Jun 2021to 2 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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
- Being tested
- platelet rich fibrin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
platelet rich fibrinBiological
we would like to measure the effect of PRF on soft and hard tissue healing
| Study group | Role | What they receive |
|---|---|---|
| A-PRF | Experimental | Not described Receives: Biological: platelet rich fibrin |
| A-PRF+ allograft bone | Experimental | Not described Receives: Biological: platelet rich fibrin |
| allograft bone+crosslinked collagen membrane | Active comparator | Not described Receives: Biological: platelet rich fibrin |
| collagen plug | Sham comparator | Not described Receives: Biological: platelet rich fibrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start7 Jun 2021
- Primary completion20 Mar 2023
- Study completion2 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for A-PRFStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yasser fahad alrayyes, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05161455
- Sponsor's protocol ID
- E-21-5999
- Status last verified
- May 2023
- First submitted
- 12 Nov 2021
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05161455
- Acronym / sponsor ID
- E-21-5999
- Conditions
- A-PRF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- 7 Jun 2021 (actual)
- Primary completion
- 20 Mar 2023 (actual)
- Study completion
- 2 May 2023 (actual)
- First posted
- 17 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
Key exclusion criteria (4 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| platelet rich fibrinwe would like to measure the effect of PRF on soft and hard tissue healing | Biological | A-PRF, A-PRF+ allograft bone, allograft bone+crosslinked collagen membrane, collagen plug |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
- Individual participant dataSharing planned: Undecided
Related trials for A-PRF
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Enrolling by invitation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing platelet rich fibrin in people with A-PRF, run by King Saud University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
soft tissue healing and migration. (time frame: 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2023; AzTrials last refreshed its copy on 28 Oct 2026.