Socket PreservationNCT04197895
Clinical and Radiographic Evaluation of Advanced Platelet Rich Fibrin in the Preservation of Alveolar Ridge Following Atraumatic Tooth Extraction
A study testing Socket preservation with APRF and natural healing in people with Socket Preservation, run by Nahed Gamal Saleh Abdelaal.
Trial summary
compare the effect of application of A-PRF in socket preservation after atraumatic tooth extraction and natural healing regarding to bone remodeling . Null hypotheis, after atraumatic extraction, socket with advanced PRF has no difference with socket with blood clot in primary outcome Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Socket Preservation
- What is being tested?
- Socket preservation with APRF and natural healing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2020to 20 Dec 2020
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The inclusion criteria are as follow :
- patients with an unremarkable medical history
- subjects with at least one site bordered by minimum of one tooth.
- Nonsmoker
- Teeth with root fracture, teeth with failed endodontic therapy or advanced caries
- Intact extraction socket with no dehiscence or fenestration.
- The buccolingual thickness of the buccal plate of bone in surgical area is 1 mm or more
Who cannot join
- Patients with systemic diseases.
- Patients with presence or history of osteonecrosis of the jaws, with use of bisphosphonates, exposure to head and neck radiation, chemotherapy.
- patients with large distinct pre-apical pathology
About this study
Official title: Clinical and Radiographic Evaluation of Advanced Platelet Rich Fibrin in the Preservation of Alveolar Ridge Following Atraumatic Tooth Extraction: A Randomized Clinical Trial
compare the effect of application of A-PRF in socket preservation after atraumatic tooth extraction and natural healing regarding to bone remodeling . Null hypotheis, after atraumatic extraction, socket with advanced PRF has no difference with socket with blood clot in primary outcome
- Conditions
- Socket Preservation
- Being tested
- Socket preservation with APRF, natural healing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Socket preservation with APRFProcedure or surgery
Socket preservation with APRF , A-PRF membranes were implanted into the extraction socket following tooth extraction. One entire A-PRF membrane would be placed at the base of the extraction socket and another A-PRF membrane will cover the extraction site then suturing will be done .Venous blood will be collected via venipuncture of the forearm with a butterfly needle into at least 10 mL sterile glass vacuum tube. The blood sample will be immediately centrifuged at 1,300 rpm (200 x g) for 8 minutes
natural healingProcedure or surgery
after atraumatic extraction , the socket will be left for natural healing after suturing
| Study group | Role | What they receive |
|---|---|---|
| test group | Experimental | Socket preservation with APRF Receives: Procedure: Socket preservation with APRF |
| control group | Active comparator | natural healing Receives: Procedure: natural healing |
What is being measured
The primary outcome is the main question the study is designed to answer.
mesial and distal height of extraction site
digital radiograph
Measured: 2 months
Secondary outcomes (1)
soft tissue thickness
will be evaluated by endo file with rubber stopper and digital caliper
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start1 Jan 2020 (estimated)
- Primary completion10 Aug 2020 (estimated)
- Study completion20 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Socket PreservationStudies 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
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nahed Gamal Saleh Abdelaal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nahed Gamal Saleh Abdelaal, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04197895
- Sponsor's protocol ID
- nana2019
- Status last verified
- Dec 2019
- First submitted
- 11 Dec 2019
- Last updated
- 13 Dec 2019
- 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 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Advanced Platelet Rich Fibrin in the Preservation of Alveolar Ridge Following Atraumatic Tooth Extraction: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04197895
- Acronym / sponsor ID
- nana2019
- Conditions
- Socket Preservation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Nahed Gamal Saleh AbdelaalUniversity, hospital or other
- Study start
- 1 Jan 2020 (estimated)
- Primary completion
- 10 Aug 2020 (estimated)
- Study completion
- 20 Dec 2020 (estimated)
- First posted
- 13 Dec 2019 (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.
compare the effect of application of A-PRF in socket preservation after atraumatic tooth extraction and natural healing regarding to bone remodeling . Null hypotheis, after atraumatic extraction, socket with advanced PRF has no difference with socket with blood clot in primary outcome
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test group | Experimental | Procedure: Socket preservation with APRFSocket preservation with APRF |
| control group | Active comparator | Procedure: natural healingnatural healing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The inclusion criteria are as follow :
Key exclusion criteria (3 listed)
- Patients with systemic diseases.
- Patients with presence or history of osteonecrosis of the jaws, with use of bisphosphonates, exposure to head and neck radiation, chemotherapy.
- patients with large distinct pre-apical pathology
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 |
|---|---|---|
| Socket preservation with APRFSocket preservation with APRF , A-PRF membranes were implanted into the extraction socket following tooth extraction. One entire A-PRF membrane would be placed at the base of the extraction socket and another A-PRF membrane will cover the extraction site then suturing will be done .Venous blood will be collected via venipuncture of the forearm with a butterfly needle into at least 10 mL sterile glass vacuum tube. The blood sample will be immediately centrifuged at 1,300 rpm (200 x g) for 8 minutes | Procedure or surgery | test group |
| natural healingafter atraumatic extraction , the socket will be left for natural healing after suturing | Procedure or surgery | control group |
Primary outcome
mesial and distal height of extraction site
Time frame: 2 months
digital radiograph
1 secondary outcome
soft tissue thickness
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Socket Preservation
Recruiting
Effect of Collagen Membrane on Ridge Preservation
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Guided Bone Regeneration Using Polydioxanone (PDO) Membrane in Sockets After Tooth Extraction
Surgery, Oral
RecruitingPhase 4
Biotivity A-C Membrane Socket Preservation Study
Alveolar Ridge Preservation
Active, not recruiting
Vallomix Socket Preservation Study
Alveolar Ridge Augmentation
Not yet recruiting
Bone and Soft Tissue Healing After Socket Preservation With NOVAMag or Permamem Membranes
Alveolar Bone Loss, Tooth Loss / Rehabilitation
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.
Questions about this trial
What is this clinical trial studying?
A study testing Socket preservation with APRF and natural healing in people with Socket Preservation, run by Nahed Gamal Saleh Abdelaal.
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 7 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 13 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
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?
mesial and distal height of extraction site (time frame: 2 months). 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 13 Dec 2019.