Alveolar Bone LossNCT06374784
Autogenous Demineralized Dentin Graft Combined With Injectable PRF + Metronidazole Versus Autogenous Demineralized Dentin Graft Combined With Injectable PRF Versus Autogenous Demineralized Dentin Graft Alone for Alveolar Ridge Preservation
A study testing Alveolar ridge preservation using autogenous demineralized dentin graft combined with injectable PRF loaded with metronidazole, Alveolar ridge preservation using autogenous demineralized dentin graft combined with injectable PRF and Alveolar ridge preservation using autogenous demineralized dentin graft alone in people with Alveolar Bone Loss, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this trial is to compare the effect of autogenous demineralized dentin graft combined with injectable PRF loaded with metronidazole (sticky demineralized tooth releasing metronidazole) versus autogenous demineralized dentin graft combined with injectable PRF (sticky demineralized tooth) versus autogenous… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Loss
- What is being tested?
- Alveolar ridge preservation using autogenous demineralized dentin graft combined with injectable PRF loaded with metronidazole, Alveolar ridge preservation using autogenous demineralized dentin graft combined with injectable PRF and Alveolar ridge preservation using autogenous demineralized dentin graft alone
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteEgypt
- Study dates
- 20 May 2024to 28 Jun 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-restorable tooth indicated for extraction in esthetic maxillary zone
- Anterior or premolar teeth
- Apical chronic pathosis
- Motivated patients, agree to sign informed consent and complete the follow-up period
- FMPS of <15% and a FMBS <10%
Who cannot join
- Pregnant or lactating females
- Active infection at extraction site
- Smokers
- Systemic conditions affecting healing (e.g. diabetes, Paget disease or hyperthyroidism, medications as bisphosphonates...)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Autogenous Demineralized Dentin Graft Combined With Injectable PRF Loaded With Metronidazole Versus Autogenous Demineralized Dentin Graft Combined With Injectable PRF Versus Autogenous Demineralized Dentin Graft Alone on Alveolar Ridge Preservation of Infected Sockets: A Randomized Controlled Clinical Trial
The aim of this trial is to compare the effect of autogenous demineralized dentin graft combined with injectable PRF loaded with metronidazole (sticky demineralized tooth releasing metronidazole) versus autogenous demineralized dentin graft combined with injectable PRF (sticky demineralized tooth) versus autogenous demineralized dentin graft (ADDG) alone on alveolar ridge preservation after extraction of non restorable, infected single-rooted teeth
Read the detailed description
Alveolar ridge preservation is a procedure that attempts to reduce bone dimensional changes that naturally take place following tooth extraction. During the last decade, efforts have been made to confirm procedures that can prevent bone resorption after extraction. The use of bone grafts aim to promote bone healing and assist bone regeneration. Various types of materials are used for socket preservation, such as autogenous bone, allograft bone, xenograft materials, and alloplast materials.
Dentin contains several growth factors, including transforming growth factor beta (TGF-β), insulin-like growth factor-II (IGF-II) and bone morphogenetic protein-2 (BMP-2), which could be of pivotal importance during any healing event. Demineralization of dentin has been further proposed to expose its collagen matrix, liberate and fossilized; growth factors and thereby enhance its regenerative capacity.
It has been proven that autogenous demineralized dentin graft is effective at reducing dimensional losses of alveolar sockets after 6 months, with no adverse effects.
The efficacy of platelet rich fibrin (PRF) in promoting wound healing and tissue regeneration is at the center of a recent academic debate. The liquid fibrinogen has been shown to bind particulate bone grafts, which are then called sticky bon. This binding improves the stabilization of the particles in the defect. It adds a potential biological effect, which could accelerate the soft tissue healing process and optimize the handling properties of the granules.
The purpose of this clinical trial is to assess the capacity and the clinical feasibility of the dentin graft processed with injectable platelet rich fibrin (I-PRF) to an adherent, tooth-derived conglomerate for socket preservation. Moreover, Platelet-rich fibrin incorporated with antibiotics showed long-term anti-bacterial effect against F. nucleatum and S. aureus.
Both autogenous demineralized dentin graft combined with injectable PRF (sticky demineralized tooth) and autogenous demineralized dentin graft (ADDG) alone, loaded with metronidazole or not, with or without collagen membrane, have been utilized for alveolar ridge preservation or augmentation but the superiority of one form over the other is not yet clear.
- Conditions
- Alveolar Bone Loss
- Being tested
- Alveolar ridge preservation using autogenous demineralized dentin graft combined with injectable PRF loaded with metronidazole, Alveolar ridge preservation using autogenous demineralized dentin graft combined with injectable PRF, Alveolar ridge preservation using autogenous demineralized dentin graft alone
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alveolar ridge preservation using autogenous demineralized dentin graft combined with injectable PRF loaded with metronidazoleProcedure or surgery
Atraumatic extraction of non-restorable teeth, then the extracted tooth will be prepared and demineralized using hydrochloric acid (HCL) acid as particulate demineralized dentin graft and processed with injectable platelet rich fibrin. The injectable PRF will be mixed with 5mg/ml metronidazole first then added to the particulate demineralized dentin graft forming sticky demineralized tooth graft with slowly released metronidazole then inserted in the extraction socket and covered then suturing
Alveolar ridge preservation using autogenous demineralized dentin graft combined with injectable PRFProcedure or surgery
Atraumatic extraction of non-restorable teeth, then the extracted tooth will be prepared and demineralized using hydrochloric acid (HCL) acid as particulate demineralized dentin graft. The injectable PRF will be added to the particulate demineralized dentin graft forming sticky demineralized tooth graft then inserted in the extraction socket and covered then suturing
Alveolar ridge preservation using autogenous demineralized dentin graft aloneProcedure or surgery
Atraumatic extraction of non-restorable teeth, then the extracted tooth will be prepared and demineralized using hydrochloric acid (HCL) acid inserted in the extraction socket as particulate demineralized dentin graft
| Study group | Role | What they receive |
|---|---|---|
| Alveolar ridge preservation using demineralized dentin combined with I-PRF + metronidazole | Experimental | Atraumatic extraction of non-restorable teeth, then the extracted tooth will be prepared and demineralized using hydrochloric acid (HCL) acid as particulate demineralized dentin graft and processed with injectable platelet rich fibrin. The injectable PRF will be mixed with 5mg/ml metronidazole first then added to the particulate demineralized dentin graft then inserted in the extraction socket and covered then suturing Receives: Procedure: Alveolar ridge preservation using autogenous demineralized dentin graft combined with injectable PRF loaded with metronidazole |
| Alveolar ridge preservation using demineralized dentin combined with I-PRF | Experimental | Atraumatic extraction of non-restorable teeth, then the extracted tooth will be prepared and demineralized using hydrochloric acid (HCL) acid as particulate demineralized dentin graft. The injectable PRF will be mixed with the particulate demineralized dentin graft then inserted in the extraction socket and covered then suturing Receives: Procedure: Alveolar ridge preservation using autogenous demineralized dentin graft combined with injectable PRF |
| Alveolar ridge preservation using autogenous demineralized dentin graft alone | Active comparator | Atraumatic extraction of non-restorable teeth, then the extracted tooth will be prepared and demineralized using hydrochloric acid (HCL) acid as particulate demineralized dentin graft and inserted in the extraction socket and covered then suturing Receives: Procedure: Alveolar ridge preservation using autogenous demineralized dentin graft alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
buccal ridge height change in mm
Difference in height linear measurements between baseline and final CBCT scans
Measured: 6 months
Secondary outcomes (5)
Alveolar ridge bucco-lingual width change in mm
Alveolar bone linear width will be measured at baseline and after 6 months using cone beam computed tomography (CBCT) scans. The change in bone width will be calculated as the subtraction of final width from baseline width and will be measured in millimetres
Measured: 6 months
Histomorphometric analysis
Bone samples from control and experimental sites will be taken during implant placement using a trephine bur of a size smaller than the implant. Samples will be examined for new bone formation, graft remnants, and soft tissue formation
Measured: 6 months
palatal ridge height change in mm
change in mm recorded in baseline and follow-up CBCT scans
Measured: 6 months
the need for additional augmentation during implant placement
the need for additional augmentation during implant placement (yes or no)
Measured: 6 months
patient discomfort and pain
patient discomfort analysis using visual analogue scale
Measured: 7 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start20 May 2024
- Primary completion2 May 2025
- Study completion28 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Alveolar Bone LossStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Talaat Mohamed Mahmoud El Behwashy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06374784
- Sponsor's protocol ID
- perio2023ARP
- Status last verified
- Dec 2025
- First submitted
- 16 Apr 2024
- Last updated
- 15 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: the results will be shared with other researchers
Publications
Jung RE, Philipp A, Annen BM, Signorelli L, Thoma DS, Hammerle CH, Attin T, Schmidlin P. Radiographic evaluation of different techniques for ridge preservation after tooth extraction: a randomized controlled clinical trial. J Clin Periodontol. 2013 Jan;40(1):90-8. doi: 10.1111/jcpe.12027. Epub 2012 Nov 19.
PubMed 23163915Elfana A, El-Kholy S, Saleh HA, Fawzy El-Sayed K. Alveolar ridge preservation using autogenous whole-tooth versus demineralized dentin grafts: A randomized controlled clinical trial. Clin Oral Implants Res. 2021 May;32(5):539-548. doi: 10.1111/clr.13722. Epub 2021 Mar 1.
PubMed 33565656van Orten A, Goetz W, Bilhan H. Tooth-Derived Granules in Combination with Platelet-Rich Fibrin ("Sticky Tooth") in Socket Preservation: A Histological Evaluation. Dent J (Basel). 2022 Feb 16;10(2):29. doi: 10.3390/dj10020029.
PubMed 35200254Elbehwashy MT, Hosny MM, Elfana A, Saleh HA, Fawzy El-Sayed K. Autogenous Demineralized Dentin Graft-Based Strategies With or Without I-PRF and Metronidazole for Ridge Preservation in Infected Sockets: A Randomized Clinical Trial. J Periodontal Res. 2026 Feb 20. doi: 10.1111/jre.70092. Online ahead of print.
PubMed 41717869
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Autogenous Demineralized Dentin Graft Combined With Injectable PRF Loaded With Metronidazole Versus Autogenous Demineralized Dentin Graft Combined With Injectable PRF Versus Autogenous Demineralized Dentin Graft Alone on Alveolar Ridge Preservation of Infected Sockets: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06374784
- Acronym / sponsor ID
- perio2023ARP
- Conditions
- Alveolar Bone Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 May 2024 (actual)
- Primary completion
- 2 May 2025 (actual)
- Study completion
- 28 Jun 2025 (actual)
- First posted
- 19 Apr 2024 (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 aim of this trial is to compare the effect of autogenous demineralized dentin graft combined with injectable PRF loaded with metronidazole (sticky demineralized tooth releasing metronidazole) versus autogenous demineralized dentin graft combined with injectable PRF (sticky demineralized tooth) versus autogenous demineralized dentin graft (ADDG) alone on alveolar ridge preservation after extraction of non restorable, infected single-rooted teeth
Detailed description
Alveolar ridge preservation is a procedure that attempts to reduce bone dimensional changes that naturally take place following tooth extraction. During the last decade, efforts have been made to confirm procedures that can prevent bone resorption after extraction. The use of bone grafts aim to promote bone healing and assist bone regeneration. Various types of materials are used for socket preservation, such as autogenous bone, allograft bone, xenograft materials, and alloplast materials.
Dentin contains several growth factors, including transforming growth factor beta (TGF-β), insulin-like growth factor-II (IGF-II) and bone morphogenetic protein-2 (BMP-2), which could be of pivotal importance during any healing event. Demineralization of dentin has been further proposed to expose its collagen matrix, liberate and fossilized; growth factors and thereby enhance its regenerative capacity.
It has been proven that autogenous demineralized dentin graft is effective at reducing dimensional losses of alveolar sockets after 6 months, with no adverse effects.
The efficacy of platelet rich fibrin (PRF) in promoting wound healing and tissue regeneration is at the center of a recent academic debate. The liquid fibrinogen has been shown to bind particulate bone grafts, which are then called sticky bon. This binding improves the stabilization of the particles in the defect. It adds a potential biological effect, which could accelerate the soft tissue healing process and optimize the handling properties of the granules.
The purpose of this clinical trial is to assess the capacity and the clinical feasibility of the dentin graft processed with injectable platelet rich fibrin (I-PRF) to an adherent, tooth-derived conglomerate for socket preservation. Moreover, Platelet-rich fibrin incorporated with antibiotics showed long-term anti-bacterial effect against F. nucleatum and S. aureus.
Both autogenous demineralized dentin graft combined with injectable PRF (sticky demineralized tooth) and autogenous demineralized dentin graft (ADDG) alone, loaded with metronidazole or not, with or without collagen membrane, have been utilized for alveolar ridge preservation or augmentation but the superiority of one form over the other is not yet clear.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Alveolar ridge preservation using demineralized dentin combined with I-PRF + metronidazole | Experimental | Procedure: Alveolar ridge preservation using autogenous demineralized dentin graft combined with injectable PRF loaded with metronidazoleAtraumatic extraction of non-restorable teeth, then the extracted tooth will be prepared and demineralized using hydrochloric acid (HCL) acid as particulate demineralized dentin graft and processed with injectable platelet rich fibrin. The injectable PRF will be mixed with 5mg/ml metronidazole first then added to the particulate demineralized dentin graft then inserted in the extraction socket and covered then suturing |
| Alveolar ridge preservation using demineralized dentin combined with I-PRF | Experimental | Procedure: Alveolar ridge preservation using autogenous demineralized dentin graft combined with injectable PRFAtraumatic extraction of non-restorable teeth, then the extracted tooth will be prepared and demineralized using hydrochloric acid (HCL) acid as particulate demineralized dentin graft. The injectable PRF will be mixed with the particulate demineralized dentin graft then inserted in the extraction socket and covered then suturing |
| Alveolar ridge preservation using autogenous demineralized dentin graft alone | Active comparator | Procedure: Alveolar ridge preservation using autogenous demineralized dentin graft aloneAtraumatic extraction of non-restorable teeth, then the extracted tooth will be prepared and demineralized using hydrochloric acid (HCL) acid as particulate demineralized dentin graft and inserted in the extraction socket and covered then suturing |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Non-restorable tooth indicated for extraction in esthetic maxillary zone
- Anterior or premolar teeth
- Apical chronic pathosis
- Motivated patients, agree to sign informed consent and complete the follow-up period
- FMPS of <15% and a FMBS <10%
Key exclusion criteria (4 listed)
- Pregnant or lactating females
- Active infection at extraction site
- Smokers
- Systemic conditions affecting healing (e.g. diabetes, Paget disease or hyperthyroidism, medications as bisphosphonates...)
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 |
|---|---|---|
| Alveolar ridge preservation using autogenous demineralized dentin graft combined with injectable PRF loaded with metronidazoleAtraumatic extraction of non-restorable teeth, then the extracted tooth will be prepared and demineralized using hydrochloric acid (HCL) acid as particulate demineralized dentin graft and processed with injectable platelet rich fibrin. The injectable PRF will be mixed with 5mg/ml metronidazole first then added to the particulate demineralized dentin graft forming sticky demineralized tooth graft with slowly released metronidazole then inserted in the extraction socket and covered then suturing | Procedure or surgery | Alveolar ridge preservation using demineralized dentin combined with I-PRF + metronidazole |
| Alveolar ridge preservation using autogenous demineralized dentin graft combined with injectable PRFAtraumatic extraction of non-restorable teeth, then the extracted tooth will be prepared and demineralized using hydrochloric acid (HCL) acid as particulate demineralized dentin graft. The injectable PRF will be added to the particulate demineralized dentin graft forming sticky demineralized tooth graft then inserted in the extraction socket and covered then suturing | Procedure or surgery | Alveolar ridge preservation using demineralized dentin combined with I-PRF |
| Alveolar ridge preservation using autogenous demineralized dentin graft aloneAtraumatic extraction of non-restorable teeth, then the extracted tooth will be prepared and demineralized using hydrochloric acid (HCL) acid inserted in the extraction socket as particulate demineralized dentin graft | Procedure or surgery | Alveolar ridge preservation using autogenous demineralized dentin graft alone |
Primary outcome
buccal ridge height change in mm
Time frame: 6 months
Difference in height linear measurements between baseline and final CBCT scans
5 secondary outcomes
Alveolar ridge bucco-lingual width change in mm
Time frame: 6 months
Histomorphometric analysis
Time frame: 6 months
palatal ridge height change in mm
Time frame: 6 months
the need for additional augmentation during implant placement
Time frame: 6 months
patient discomfort and pain
Time frame: 7 days postoperatively
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 15 Dec 2025.
- Background: PubMed 23163915Jung RE, Philipp A, Annen BM, Signorelli L, Thoma DS, Hammerle CH, Attin T, Schmidlin P. Radiographic evaluation of different techniques for ridge preservation after tooth extraction: a randomized controlled clinical trial. J Clin Periodontol. 2013 Jan;40(1):90-8. doi: 10.1111/jcpe.12027. Epub 2012 Nov 19.
- Background: PubMed 33565656Elfana A, El-Kholy S, Saleh HA, Fawzy El-Sayed K. Alveolar ridge preservation using autogenous whole-tooth versus demineralized dentin grafts: A randomized controlled clinical trial. Clin Oral Implants Res. 2021 May;32(5):539-548. doi: 10.1111/clr.13722. Epub 2021 Mar 1.
- Background: PubMed 35200254van Orten A, Goetz W, Bilhan H. Tooth-Derived Granules in Combination with Platelet-Rich Fibrin ("Sticky Tooth") in Socket Preservation: A Histological Evaluation. Dent J (Basel). 2022 Feb 16;10(2):29. doi: 10.3390/dj10020029.
- Derived from this study: PubMed 41717869Elbehwashy MT, Hosny MM, Elfana A, Saleh HA, Fawzy El-Sayed K. Autogenous Demineralized Dentin Graft-Based Strategies With or Without I-PRF and Metronidazole for Ridge Preservation in Infected Sockets: A Randomized Clinical Trial. J Periodontal Res. 2026 Feb 20. doi: 10.1111/jre.70092. Online ahead of print.
- Individual participant dataSharing planned: No. the results will be shared with other researchers
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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 Alveolar ridge preservation using autogenous demineralized dentin graft combined with injectable PRF loaded with metronidazole, Alveolar ridge preservation using autogenous demineralized dentin graft combined with injectable PRF and Alveolar ridge preservation using autogenous demineralized dentin graft alone in people with Alveolar Bone Loss, run by Cairo 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 5 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 15 Dec 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?
buccal ridge height change in mm (time frame: 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 NCT06374784, which also lists 4 linked publications.
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 15 Dec 2025.