Unrestorable DentitionNCT06027528
Evaluation of Socket Preservation Using Autogenous Dentine Graft With Or Without Autologous Fibrin Glue
A study testing dentin graft mixed with autologous fibrin glue and dentin graft in people with Unrestorable Dentition, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this interventional study is to investigate the dimensional changes in buccolingual alveolar ridge width in socket preservation using sticky dentin vs dentin graft alone The main question: is dentin graft mixed with autologous fibrin glue has better dimensional changes than using dentin graft alone ?… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Unrestorable Dentition
- What is being tested?
- dentin graft mixed with autologous fibrin glue and dentin graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2023to 31 Aug 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
- Systemically healthy patients ≥18 years old
- Nonsmoker
- Teeth with root fracture, teeth with failed endodontic therapy or advanced caries
- Intact extraction socket with no dehiscence or fenestration.
Who cannot join
- Patients with systemic diseases.
- Patients with dehiscence or fenestrations
- 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
- Smokers of more than 10 cigarettes a day or equivalent to cigarettes
- Breastfeeding or pregnant women
- Patients without availability to attend follow-up visits or patients rejecting to sign the informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Socket Preservation Using Autogenous Dentine Graft With Or Without Autologous Fibrin Glue: A Randomized Controlled Clinical Trial
- The aim of this interventional study is to investigate the dimensional changes in buccolingual alveolar ridge width in socket preservation using sticky dentin vs dentin graft alone
- The main question: is dentin graft mixed with autologous fibrin glue has better dimensional changes than using dentin graft alone ?
- outcomes: Change in buccolingual alveolar ridge width as well as apico-coronal alveolar ridge height
Read the detailed description
- Aim of the study: The aim of this study is to investigate the dimensional changes in buccolingual alveolar ridge width. As well as the apico-coronal alveolar ridge height following tooth extraction when using sticky grafts combined with demineralized dentin grafts for socket preservation.
- Research Procedure in brief:
This study will be carried out on patients enrolled from the Outpatient Clinic of Oral Medicine and Periodontology department, Faculty of Dentistry, Cairo University. *operative procedure: Before tooth extraction, probing depths (PD), gingival recession (GR), and bleeding on probing (BOP) will be assessed at six sites (mid-facial, mesio-facial, disto-facial, mid-palatal, mesio-palatal, and disto-palatal) around the tooth to be extracted and on the adjacent teeth to verify their periodontal status. Local anesthesia will be administered by infiltration to achieve the necessary anesthesia to allow extraction of the indicated tooth. Flapless atraumatic extraction will be done. Extracted teeth will be cleaned from periodontal ligaments, cementum, soft tissue attachment, caries or restorations (if present), using a high-speed stone. The pulp chamber will be cleaned with sterile endodontic files. Then, teeth will be grinded to fine particles.
The particles prepared will be immersed tooth in alcohol for 10 min for disinfection, then washed twice in saline and dried using sterile gauze.
Then the dentine graft particles will be prepared by demineralization of tooth particles in 0.6N hydrochloric acid for 30 min to achieve demineralization then washed twice in saline and dried with sterile gauze
Then the patient will be randomly assigned to one of the treatment groups:
In group 1 (control group) Demineralized dentine graft will be placed in the socket.
In group 2 (test group):
Sticky graft preparation will be done as follows:
- Small amount of patient's venous blood (8-10cc) is drawn via venipuncture, and the blood is placed into non-coated vacutainers to obtain autologous fibrin glue (AFG), which will make sticky graft.
- The blood in the test tubes is centrifuged at 2700-3000 rpm for 2-3 mins.
- The upper autologous fibrin glue is obtained with syringe and mixed with particulate of dentine graft and allows for 5-10 minutes for polymerization in order to produce sticky graft.
- The prepared sticky dentin graft will then be inserted in the socket.
- Post operative radiograph:
Cone beam CT will be taken post surgically to measure the buccolingual dimension in the same day of the surgery.
*Post-surgical procedure: (six months after socket preservation) Another Cone beam CT will be taken to measure the outcomes by superimposition of the 2 CBCT
- Conditions
- Unrestorable Dentition
- Being tested
- dentin graft mixed with autologous fibrin glue, dentin graft
- Keywords
- socket preservation, alveolar ridge preservation, dentin graft, autologous fibrin glue, sticky dentin, sticky graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dentin graft mixed with autologous fibrin glueProcedure or surgery
extracted tooth will be grinded into small particles to form dentin graft that will be mixed with autologous fibrin glue to be grafted in the extracted socket using centrifuge
dentin graftProcedure or surgery
extracted tooth will be grafted in the socket
| Study group | Role | What they receive |
|---|---|---|
| dentin graft mixed with autologous fibrin glue | Experimental | extracted tooth will be grinded into small particles to form dentin graft that will be mixed with autologous fibrin glue to be grafted in the extracted socket Receives: Procedure: dentin graft mixed with autologous fibrin glue |
| dentin graft | Active comparator | extracted tooth will be grafted in the extracted socket Receives: Procedure: dentin graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in buccolingual alveolar ridge width dimensions immediately after tooth extraction (baseline) and ≥ 6 months after (follow-up).
superimposition of the 2 CBCT and using Scans which will be exported as DICOM format to 3D viewer software
Measured: 6 month
Secondary outcomes (1)
changes in apico-coronal alveolar ridge height immediately after tooth extraction and 6 months after
superimposition of the 2 CBCT and using Scans which will be exported as DICOM format to 3D viewer software
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 posted7 Sep 2023
- Study start1 Sep 2023
- Primary completion21 Mar 2024
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unrestorable DentitionStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Islam Mohamed Sherif, Cairo University
- Investigators
- Amr Zahran, Professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06027528
- Sponsor's protocol ID
- 22623
- Status last verified
- Apr 2026
- First submitted
- 31 Aug 2023
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Socket Preservation Using Autogenous Dentine Graft With Or Without Autologous Fibrin Glue: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06027528
- Acronym / sponsor ID
- 22623
- Conditions
- Unrestorable Dentition
- Keywords
- socket preservation, alveolar ridge preservation, dentin graft, autologous fibrin glue, sticky dentin, sticky graft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 21 Mar 2024 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 7 Sep 2023 (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 interventional study is to investigate the dimensional changes in buccolingual alveolar ridge width in socket preservation using sticky dentin vs dentin graft alone
- The main question: is dentin graft mixed with autologous fibrin glue has better dimensional changes than using dentin graft alone ?
- outcomes: Change in buccolingual alveolar ridge width as well as apico-coronal alveolar ridge height
Detailed description
- Aim of the study: The aim of this study is to investigate the dimensional changes in buccolingual alveolar ridge width. As well as the apico-coronal alveolar ridge height following tooth extraction when using sticky grafts combined with demineralized dentin grafts for socket preservation.
- Research Procedure in brief:
This study will be carried out on patients enrolled from the Outpatient Clinic of Oral Medicine and Periodontology department, Faculty of Dentistry, Cairo University. *operative procedure: Before tooth extraction, probing depths (PD), gingival recession (GR), and bleeding on probing (BOP) will be assessed at six sites (mid-facial, mesio-facial, disto-facial, mid-palatal, mesio-palatal, and disto-palatal) around the tooth to be extracted and on the adjacent teeth to verify their periodontal status. Local anesthesia will be administered by infiltration to achieve the necessary anesthesia to allow extraction of the indicated tooth. Flapless atraumatic extraction will be done. Extracted teeth will be cleaned from periodontal ligaments, cementum, soft tissue attachment, caries or restorations (if present), using a high-speed stone. The pulp chamber will be cleaned with sterile endodontic files. Then, teeth will be grinded to fine particles.
The particles prepared will be immersed tooth in alcohol for 10 min for disinfection, then washed twice in saline and dried using sterile gauze.
Then the dentine graft particles will be prepared by demineralization of tooth particles in 0.6N hydrochloric acid for 30 min to achieve demineralization then washed twice in saline and dried with sterile gauze
Then the patient will be randomly assigned to one of the treatment groups:
In group 1 (control group) Demineralized dentine graft will be placed in the socket.
In group 2 (test group):
Sticky graft preparation will be done as follows:
- Small amount of patient's venous blood (8-10cc) is drawn via venipuncture, and the blood is placed into non-coated vacutainers to obtain autologous fibrin glue (AFG), which will make sticky graft.
- The blood in the test tubes is centrifuged at 2700-3000 rpm for 2-3 mins.
- The upper autologous fibrin glue is obtained with syringe and mixed with particulate of dentine graft and allows for 5-10 minutes for polymerization in order to produce sticky graft.
- The prepared sticky dentin graft will then be inserted in the socket.
- Post operative radiograph:
Cone beam CT will be taken post surgically to measure the buccolingual dimension in the same day of the surgery.
*Post-surgical procedure: (six months after socket preservation) Another Cone beam CT will be taken to measure the outcomes by superimposition of the 2 CBCT
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dentin graft mixed with autologous fibrin glue | Experimental | Procedure: dentin graft mixed with autologous fibrin glueextracted tooth will be grinded into small particles to form dentin graft that will be mixed with autologous fibrin glue to be grafted in the extracted socket |
| dentin graft | Active comparator | Procedure: dentin graftextracted tooth will be grafted in the extracted socket |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Systemically healthy patients ≥18 years old
- Nonsmoker
- Teeth with root fracture, teeth with failed endodontic therapy or advanced caries
- Intact extraction socket with no dehiscence or fenestration.
Key exclusion criteria (7 listed)
- Patients with systemic diseases.
- Patients with dehiscence or fenestrations
- 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
- Smokers of more than 10 cigarettes a day or equivalent to cigarettes
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 |
|---|---|---|
| dentin graft mixed with autologous fibrin glueextracted tooth will be grinded into small particles to form dentin graft that will be mixed with autologous fibrin glue to be grafted in the extracted socket using centrifuge | Procedure or surgery | dentin graft mixed with autologous fibrin glue |
| dentin graftextracted tooth will be grafted in the socket | Procedure or surgery | dentin graft |
Primary outcome
Change in buccolingual alveolar ridge width dimensions immediately after tooth extraction (baseline) and ≥ 6 months after (follow-up).
Time frame: 6 month
superimposition of the 2 CBCT and using Scans which will be exported as DICOM format to 3D viewer software
1 secondary outcome
changes in apico-coronal alveolar ridge height immediately after tooth extraction and 6 months after
Time frame: 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 9 Apr 2026.
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.
Amr Zahran, Professor study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dentin graft mixed with autologous fibrin glue and dentin graft in people with Unrestorable Dentition, 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 4 inclusion and 7 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 9 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?
Change in buccolingual alveolar ridge width dimensions immediately after tooth extraction (baseline) and ≥ 6 months after (follow-up). (time frame: 6 month). 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 9 Apr 2026.