Atrophic MandibleNCT07164417
Two Types of PRF Membranes in Management of Dehiscence Defect in Posterior Mandible
A study testing e-PRF membrane will be used with xenograft simultaneously with implant placement. and PRF membrane will be used with xenograft simultaneously with implant placement in people with Atrophic Mandible, run by Alexandria University at 1 site in Egypt.
Trial summary
Background: Placement of implants in an atrophic posterior ridge is a challenge for so many clinicians. The success of dental implants depends on the volume of alveolar bone available to provide stability. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Atrophic Mandible
- What is being tested?
- e-PRF membrane will be used with xenograft simultaneously with implant placement. and PRF membrane will be used with xenograft simultaneously with implant placement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Oct 2024to 20 Jan 2025
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient with one or more missing posterior mandibular teeth.
- Patient with atrophic posterior mandible with residual ridge width in the range of 4 to 6mm.
- Patient with good oral hygiene and acceptable inter-arch space less than or equal to the restoration
Who cannot join
- The patient underwent alveolar ridge reconstruction in the same area.
- Patients with immune diseases, uncontrolled hypertension, and uncontrolled diabetes.
- Patient with any pathological condition at the site of surgery.
- Heavy smoker, alcohol abuse, parafunctional habits.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt
Alexandria, Azarita, 00203
About this study
Official title: Comparing Two Types of PRF Membranes in Management of Dehiscence Defect With Simultaneous Implant Placement in Posterior Mandible (Randomized Controlled Clinical Trial)
Background: Placement of implants in an atrophic posterior ridge is a challenge for so many clinicians. The success of dental implants depends on the volume of alveolar bone available to provide stability. Bone grafting using xenograft with PRF and e-PRF as a membrane has shown promising results in both bone healing and defect reconstruction. Aim of the study: to evaluate the effect of Platelet-rich fibrin (PRF) and Extended Platelet-rich fibrin (e-PRF) as a membrane with xenograft to increase the width of ridge in posterior mandible with simultaneous implant placement.
- Conditions
- Atrophic Mandible
- Being tested
- e-PRF membrane will be used with xenograft simultaneously with implant placement., PRF membrane will be used with xenograft simultaneously with implant placement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
e-PRF membrane will be used with xenograft simultaneously with implant placement.Other
Peripheral blood is collected in plain tubes and centrifuged (700-2000 g, 8 min) to separate plasma from red cells. The first 2-4 mL of platelet-poor plasma (PPP) is withdrawn and heated at 75 °C for 10 minutes to form albumin gel, then cooled for 1-2 minutes. Meanwhile, the remaining blood fractions (buffy coat, liquid PRF, red cells) are kept cooled to prevent premature clotting.
PRF membrane will be used with xenograft simultaneously with implant placementOther
Peripheral blood is collected in 9-10 mL additive-free tubes and centrifuged horizontally at 700-2000 g for 8 minutes.
| Study group | Role | What they receive |
|---|---|---|
| PRF | Active comparator | Not described Receives: Other: PRF membrane will be used with xenograft simultaneously with implant placement |
| e-PRF | Experimental | Not described Receives: Other: e-PRF membrane will be used with xenograft simultaneously with implant placement. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in implant stability
Osstell device will be used to measure the implant stability, primary stability Just after implant placement, and secondary stability 6 months from the time of implant placement. The measured values will be recorded in ISQ from 1 to 100, Implant stability is directly proportional to ISQ value
Measured: baseline and 6 months
Secondary outcomes (4)
change in pain scores
Visual Analogue Scale (VAS) will be used to assess pain for 7 days postoperatively using a 10-point (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe)
Measured: uo to 7 days
Change in edema scores
Assessment of edema will be done immediately, post-operative on the 2nd, 3rd, and 7th days as follows:
no inflammation= none intraoral swelling confined to the surgical field = mild extraoral swelling in the surgical zone= moderate extraoral swelling spreading beyond the surgical zone= intense
Measured: up to 7 days
change in bone width gain
CBCT will be used
Measured: baseline and 6 months
change in bone density
CBCt will be used
Measured: baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start12 Oct 2024
- Primary completion20 Jan 2025
- Study completion20 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrophic MandibleStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07164417
- Sponsor's protocol ID
- 0936-06/2024
- Status last verified
- Sep 2025
- First submitted
- 4 Sep 2025
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abla MMA, Shaaban AM, Younis PA. Comparing two types of platelet-rich fibrin membranes in the management of dehiscence defects with simultaneous implant placement in the posterior mandible: a randomized controlled trial. BMC Oral Health. 2026 Mar 27;26(1):591. doi: 10.1186/s12903-026-08043-w.
PubMed 41896835
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Two Types of PRF Membranes in Management of Dehiscence Defect With Simultaneous Implant Placement in Posterior Mandible (Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT07164417
- Acronym / sponsor ID
- 0936-06/2024
- Conditions
- Atrophic Mandible
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 12 Oct 2024 (actual)
- Primary completion
- 20 Jan 2025 (actual)
- Study completion
- 20 Jan 2025 (actual)
- First posted
- 10 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.
Background: Placement of implants in an atrophic posterior ridge is a challenge for so many clinicians. The success of dental implants depends on the volume of alveolar bone available to provide stability. Bone grafting using xenograft with PRF and e-PRF as a membrane has shown promising results in both bone healing and defect reconstruction. Aim of the study: to evaluate the effect of Platelet-rich fibrin (PRF) and Extended Platelet-rich fibrin (e-PRF) as a membrane with xenograft to increase the width of ridge in posterior mandible with simultaneous implant placement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRF | Active comparator | Other: PRF membrane will be used with xenograft simultaneously with implant placement |
| e-PRF | Experimental | Other: e-PRF membrane will be used with xenograft simultaneously with implant placement. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patient with one or more missing posterior mandibular teeth.
- Patient with atrophic posterior mandible with residual ridge width in the range of 4 to 6mm.
- Patient with good oral hygiene and acceptable inter-arch space less than or equal to the restoration
Key exclusion criteria (4 listed)
- The patient underwent alveolar ridge reconstruction in the same area.
- Patients with immune diseases, uncontrolled hypertension, and uncontrolled diabetes.
- Patient with any pathological condition at the site of surgery.
- Heavy smoker, alcohol abuse, parafunctional habits.
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 |
|---|---|---|
| e-PRF membrane will be used with xenograft simultaneously with implant placement.Peripheral blood is collected in plain tubes and centrifuged (700-2000 g, 8 min) to separate plasma from red cells. The first 2-4 mL of platelet-poor plasma (PPP) is withdrawn and heated at 75 °C for 10 minutes to form albumin gel, then cooled for 1-2 minutes. Meanwhile, the remaining blood fractions (buffy coat, liquid PRF, red cells) are kept cooled to prevent premature clotting. | Other | e-PRF |
| PRF membrane will be used with xenograft simultaneously with implant placementPeripheral blood is collected in 9-10 mL additive-free tubes and centrifuged horizontally at 700-2000 g for 8 minutes. | Other | PRF |
Primary outcome
Change in implant stability
Time frame: baseline and 6 months
Osstell device will be used to measure the implant stability, primary stability Just after implant placement, and secondary stability 6 months from the time of implant placement. The measured values will be recorded in ISQ from 1 to 100, Implant stability is directly proportional to ISQ value
4 secondary outcomes
change in pain scores
Time frame: uo to 7 days
Change in edema scores
Time frame: up to 7 days
change in bone width gain
Time frame: baseline and 6 months
change in bone density
Time frame: baseline and 6 months
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 10 Sep 2025.
- Derived from this study: PubMed 41896835Abla MMA, Shaaban AM, Younis PA. Comparing two types of platelet-rich fibrin membranes in the management of dehiscence defects with simultaneous implant placement in the posterior mandible: a randomized controlled trial. BMC Oral Health. 2026 Mar 27;26(1):591. doi: 10.1186/s12903-026-08043-w.
- Individual participant dataSharing planned: No
Related trials for Atrophic Mandible
Active, not recruiting
The Aim of the Study Will be Clinically and Radio Graphically Comparison of Two Implant Designs Used to Treat Atrophied Mandible . Implant Design Comparison Will Done for Implant Stability,Peri-implant Soft Tissue Health Changes and Bone Changes .Patients Will be Divided Randomly Into Two Group
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Comparison Between Neutral Zone and Admixed Impression Techniques for Atrophic Mandibular Ridges
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Melatonin Effect on Immediate Dental Implants in the Posterior Mandible
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HydroGraft for Mandibular Horizontal Ridge Atrophy Augmentation.
Alveolar Ridge Atrophy
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 e-PRF membrane will be used with xenograft simultaneously with implant placement. and PRF membrane will be used with xenograft simultaneously with implant placement in people with Atrophic Mandible, run by Alexandria 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 3 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 10 Sep 2025. 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?
Change in implant stability (time frame: baseline and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07164417, which also lists 1 linked publication.
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 10 Sep 2025.