Tooth Extraction Site HealingNCT07153133
Efficacy of Albumin Platelet Rich Fibrin on Complications After Mandibular Third Molar Extraction.
A study testing Alb-PRF Autologous Albumin Gel and Surgical extraction of impacted third molar in people with Tooth Extraction Site Healing, run by Mansoura University at 1 site in Egypt.
Trial summary
Sixteen patients with bilateral impacted lower third molars seeking treatment will be recruited from the out-patient clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry at Mansoura University. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Tooth Extraction Site Healing
- What is being tested?
- Alb-PRF Autologous Albumin Gel and Surgical extraction of impacted third molar
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Sep 2025to 1 Mar 2026
- 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 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Healthy patients classified as ASA (American Society of Anesthesiologists) Physical Status Classification Class I.
- Patients seeking extraction of both mandibular third molars.
- Patients aged 18 - 40 years old by the day of surgery.
- Patients willing to participate in the study and commit to regular follow-up appointments.
Who cannot join
- Heavy Smokers (more than 25 cigarettes per day).
- Patients with Poor oral hygiene.
- Patients with history of a chemotherapy or radiotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Albumin Platelet Rich Fibrin on Complications After Mandibular Third Molar Extraction: A Clinical and Biochemical Study
Sixteen patients with bilateral impacted lower third molars seeking treatment will be recruited from the out-patient clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry at Mansoura University.
- Conditions
- Tooth Extraction Site Healing
- Being tested
- Alb-PRF Autologous Albumin Gel, Surgical extraction of impacted third molar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alb-PRF Autologous Albumin GelDevice
Also called Alb-PRF
Socket curettage and bone filing will be done using a bone curette and bone file, respectively.
Extraction sockets with albumin gel application. 0.2 ml of autologous albumin gel will be applied to all four edges of the extraction socket
Surgical extraction of impacted third molarProcedure or surgery
Socket curettage and bone filing will be done using a bone curette and bone file, respectively.
Extraction sockets will be left without autologous albumin gel application.
| Study group | Role | What they receive |
|---|---|---|
| Control: No Autologous Albumin Gel applied Side | Active comparator | Surgical extraction of impacted third molar without autologous albumin gel application. Receives: Procedure: Surgical extraction of impacted third molar |
| Study: Autologous Albumin Gel applied Side | Experimental | Surgical extraction of impacted third molar with autologous albumin gel application. Receives: Device: Alb-PRF Autologous Albumin Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Facial Swelling (Edema): in Centimeters
Measurements will be taken before surgery (baseline). Swelling will be evaluated by comparing the difference between preoperative and postoperative measurements. Swelling will be evaluated in Centimeters using a tape measure.
Performed on the patient's operated site using these reference points:
- A) Lateral corner of the eye/angle of the mandible
- B) Tragus/outer corner of the mouth
- C) Tragus/soft tissue pogonion
Measured: first day, third day and seventh day
Wound Healing: Disturbed/Not Disturbed
The area of operation will be examined for Any manifestations of wound healing disturbance including:
- Swelling, redness, hotness, pus discharge, signs and symptoms of infection, Wound dehiscence
- Exposure of underlying hard tissue will be carefully noted
Measured: first day, third day and seventh day
Postoperative pain severity assessment : using a 10 point Visual Analogue Scale (VAS)
Pain will be evaluated using Visual Analogue Scale (VAS). Which is a 10 point scale, in which the minimum end '0" represents no pain, while the maximum end 10" represents the worst pain.
Measured: first day, third day and seventh day
Laboratory Assessments of multiple blood/Biochemical markers and their concentrations
First 5 cm of blood will be withdrawn under aseptic conditions using sterile venipuncture, then blood will be separated immediately by centrifugation (3000 rpm). To be assessed using enzyme-linked immunosorbent assays (ELISA) kits according to the manufacturer's protocol for their Serum concentrations of: interleukin 6, macrophage inflammatory protein, granulocyte macrophage colony-stimulation factor, and vascular endothelial growth factor
Measured: first day, third day and seventh day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start20 Sep 2025
- Primary completion25 Feb 2026
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth Extraction Site HealingStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nader Matrouk Farag AL-Saihani, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07153133
- Sponsor's protocol ID
- Ms.25.03.5
- Status last verified
- Aug 2025
- First submitted
- 26 Aug 2025
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Albumin Platelet Rich Fibrin on Complications After Mandibular Third Molar Extraction: A Clinical and Biochemical Study
- ClinicalTrials.gov ID
- NCT07153133
- Acronym / sponsor ID
- Ms.25.03.5
- Conditions
- Tooth Extraction Site Healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 20 Sep 2025 (actual)
- Primary completion
- 25 Feb 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 3 Sep 2025 (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.
Sixteen patients with bilateral impacted lower third molars seeking treatment will be recruited from the out-patient clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry at Mansoura University.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control: No Autologous Albumin Gel applied Side | Active comparator | Procedure: Surgical extraction of impacted third molarSurgical extraction of impacted third molar without autologous albumin gel application. |
| Study: Autologous Albumin Gel applied Side | Experimental | Device: Alb-PRF Autologous Albumin GelSurgical extraction of impacted third molar with autologous albumin gel application. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy patients classified as ASA (American Society of Anesthesiologists) Physical Status Classification Class I.
- Patients seeking extraction of both mandibular third molars.
- Patients aged 18 - 40 years old by the day of surgery.
- Patients willing to participate in the study and commit to regular follow-up appointments.
Key exclusion criteria (3 listed)
- Heavy Smokers (more than 25 cigarettes per day).
- Patients with Poor oral hygiene.
- Patients with history of a chemotherapy or radiotherapy
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 |
|---|---|---|
| Alb-PRF Autologous Albumin GelAlso: Alb-PRFSocket curettage and bone filing will be done using a bone curette and bone file, respectively. Extraction sockets with albumin gel application. 0.2 ml of autologous albumin gel will be applied to all four edges of the extraction socket | Device | Study: Autologous Albumin Gel applied Side |
| Surgical extraction of impacted third molarSocket curettage and bone filing will be done using a bone curette and bone file, respectively. Extraction sockets will be left without autologous albumin gel application. | Procedure or surgery | Control: No Autologous Albumin Gel applied Side |
Primary outcome
Assessment of Facial Swelling (Edema): in Centimeters
Time frame: first day, third day and seventh day
Measurements will be taken before surgery (baseline). Swelling will be evaluated by comparing the difference between preoperative and postoperative measurements. Swelling will be evaluated in Centimeters using a tape measure. Performed on the patient's operated site using these reference points: * A) Lateral corner of the eye/angle of the mandible * B) Tragus/outer corner of the mouth * C) Tragus/soft tissue pogonion
Wound Healing: Disturbed/Not Disturbed
Time frame: first day, third day and seventh day
The area of operation will be examined for Any manifestations of wound healing disturbance including: * Swelling, redness, hotness, pus discharge, signs and symptoms of infection, Wound dehiscence * Exposure of underlying hard tissue will be carefully noted
Postoperative pain severity assessment : using a 10 point Visual Analogue Scale (VAS)
Time frame: first day, third day and seventh day
Pain will be evaluated using Visual Analogue Scale (VAS). Which is a 10 point scale, in which the minimum end '0" represents no pain, while the maximum end 10" represents the worst pain.
Laboratory Assessments of multiple blood/Biochemical markers and their concentrations
Time frame: first day, third day and seventh day
First 5 cm of blood will be withdrawn under aseptic conditions using sterile venipuncture, then blood will be separated immediately by centrifugation (3000 rpm). To be assessed using enzyme-linked immunosorbent assays (ELISA) kits according to the manufacturer's protocol for their Serum concentrations of: interleukin 6, macrophage inflammatory protein, granulocyte macrophage colony-stimulation factor, and vascular endothelial growth factor
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 21 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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 Alb-PRF Autologous Albumin Gel and Surgical extraction of impacted third molar in people with Tooth Extraction Site Healing, run by Mansoura University at 1 site in Egypt.
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 4 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: finished, as of the sponsor's last update on 21 Apr 2026. 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 Egypt. 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. 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?
Assessment of Facial Swelling (Edema): in Centimeters (time frame: first day, third day and seventh day). The study lists 4 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 21 Apr 2026.