Ridge PreservationNCT05437172
Evaluation of Autogenous Demineralized Dentin Graft for Ridge Preservation With and Without Injectable Platelet Rich Fibrin
A study testing injectable platelet rich fibrin with demineralized dentin graft and demineralized dentin graft in people with Ridge Preservation and Alveolar Bone Loss, run by Cairo University at 1 site in Egypt.
Trial summary
Ridge preservation should be considered whenever possible after tooth extraction. Whether implant placement would be performed or for aesthetic consideration at pontic sites when conventional bridge is planned. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ridge Preservation, Alveolar Bone Loss, Dentin Graft
- What is being tested?
- injectable platelet rich fibrin with demineralized dentin graft and demineralized dentin graft
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jun 2022to 15 Dec 2023
- 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
- Age ≥ 18 years need of at least one single rooted tooth extraction.
- Non-restorable teeth.
- Systemically healthy patients.
- Good oral hygiene, Plaque index less than 15%.
- Non-smoker or Smoking ≤ 10 cigarettes/day.
- Cooperative patients able and accept to come for follow up appointments.
Who cannot join
- Any interim intervention that may have affected any of the outcomes of interest.
- Pregnant and lactation females.
- Smoking ˃ 10 cigarettes/day.
- Patients reporting systemic conditions that may compromise healing or bone metabolism (eg: diabetes).
- Patients with poor oral hygiene.
- Any known allergies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiographic Evaluation of Autogenous Demineralized Dentin Graft for Ridge Preservation With and Without Injectable Platelet Rich Fibrin (A Randomized Controlled Clinical Trial)
Ridge preservation should be considered whenever possible after tooth extraction. Whether implant placement would be performed or for aesthetic consideration at pontic sites when conventional bridge is planned. Ridge preservation aims to maximize the bone formation accompanied with good soft tissue architecture to facilitate implant and prosthetic replacement restoring function, phonetics and aesthetics. the Aim of the study is To evaluate the bucco-lingual ridge width clinically and radiographically, height of buccal and lingual ridges of the socket after application of injectable platelet rich fibrin and autogenous dentin graft.
- Conditions
- Ridge Preservation, Alveolar Bone Loss, Dentin Graft
- Being tested
- injectable platelet rich fibrin with demineralized dentin graft, demineralized dentin graft
- 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.
injectable platelet rich fibrin with demineralized dentin graftProcedure or surgery
after atraumatic extraction, collection of whole venous blood (9 ml) in sterile vacutainer tubes will be done without anticoagulant added, vacutainer tubes will be then placed in a centrifugal machine at 700 revolutions per minute (rpm) for 3 min with a tube filled with water to maintain the balance during the centrifuging process. ADDG particles 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. Graft particles will be loaded at the defect site to restore ridge form, large metal condenser was used to adapt the graft to the defect and stabilizing the graft with sutures.
demineralized dentin graftProcedure or surgery
after atraumatic extraction, ADDG 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.
Graft particles will be loaded at the defect site to restore ridge form, large metal condenser was used to adapt the graft to the defect and stabilizing the graft with sutures.
| Study group | Role | What they receive |
|---|---|---|
| injectable platelet rich fibrin with deminerlized dentin graft | Experimental | injectable platelet rich fibrin with deminerlized dentin graft for ridge preservation after teeth extraction Receives: Procedure: injectable platelet rich fibrin with demineralized dentin graft |
| deminerlized dentin graft | Active comparator | deminerlized dentin graft for ridge preservation after teeth extraction Receives: Procedure: demineralized dentin graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic Bucco-lingual ridge width change
radiographic measurement
Measured: up to 24 weeks
Secondary outcomes (5)
Changes in the height of the socket buccal and lingual ridges.
radiographic measurement
Measured: up to 24 weeks
postoperative pain
Visual analogue scale from zero (better) to 10 (worse)
Measured: immediately after the procedure
Patient satisfaction
binary yes and no
Measured: immediately after the procedure
Keratinized tissue width
periodontal probe measurement
Measured: up to 24 weeks
chair time
in minutes
Measured: immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start30 Jun 2022
- Primary completion1 Jul 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ridge PreservationStudies 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Odai Amer Ahmad Hwafdeh, Cairo University
- Investigators
- Odai A Hwafdeh, BDS, Principal investigator, Master studentNesma M Shemais, PhD, Study director, Lecturer of Oral Medicine and Periodontology, Faculty of Dentistry, Cairo UniversityMona S Darhous, PhD, Study chair, Professor of Oral Medicine and Periodontology, Faculty of Dentistry, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05437172
- Sponsor's protocol ID
- Shaam
- Status last verified
- Feb 2025
- First submitted
- 23 Jun 2022
- Last updated
- 13 Feb 2025
- Results posted
- 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 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Autogenous Demineralized Dentin Graft for Ridge Preservation With and Without Injectable Platelet Rich Fibrin (A Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT05437172
- Acronym / sponsor ID
- Shaam
- Conditions
- Ridge Preservation, Alveolar Bone Loss, Dentin Graft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 29 Jun 2022 (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.
Ridge preservation should be considered whenever possible after tooth extraction. Whether implant placement would be performed or for aesthetic consideration at pontic sites when conventional bridge is planned. Ridge preservation aims to maximize the bone formation accompanied with good soft tissue architecture to facilitate implant and prosthetic replacement restoring function, phonetics and aesthetics. the Aim of the study is To evaluate the bucco-lingual ridge width clinically and radiographically, height of buccal and lingual ridges of the socket after application of injectable platelet rich fibrin and autogenous dentin graft.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| injectable platelet rich fibrin with deminerlized dentin graft | Experimental | Procedure: injectable platelet rich fibrin with demineralized dentin graftinjectable platelet rich fibrin with deminerlized dentin graft for ridge preservation after teeth extraction |
| deminerlized dentin graft | Active comparator | Procedure: demineralized dentin graftdeminerlized dentin graft for ridge preservation after teeth extraction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years need of at least one single rooted tooth extraction.
- Non-restorable teeth.
- Systemically healthy patients.
- Good oral hygiene, Plaque index less than 15%.
- Non-smoker or Smoking ≤ 10 cigarettes/day.
Key exclusion criteria (6 listed)
- Any interim intervention that may have affected any of the outcomes of interest.
- Pregnant and lactation females.
- Smoking ˃ 10 cigarettes/day.
- Patients reporting systemic conditions that may compromise healing or bone metabolism (eg: diabetes).
- Patients with poor oral hygiene.
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 |
|---|---|---|
| injectable platelet rich fibrin with demineralized dentin graftafter atraumatic extraction, collection of whole venous blood (9 ml) in sterile vacutainer tubes will be done without anticoagulant added, vacutainer tubes will be then placed in a centrifugal machine at 700 revolutions per minute (rpm) for 3 min with a tube filled with water to maintain the balance during the centrifuging process. ADDG particles 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. Graft particles will be loaded at the defect site to restore ridge form, large metal condenser was used to adapt the graft to the defect and stabilizing the graft with sutures. | Procedure or surgery | injectable platelet rich fibrin with deminerlized dentin graft |
| demineralized dentin graftafter atraumatic extraction, ADDG 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. Graft particles will be loaded at the defect site to restore ridge form, large metal condenser was used to adapt the graft to the defect and stabilizing the graft with sutures. | Procedure or surgery | deminerlized dentin graft |
Primary outcome
Radiographic Bucco-lingual ridge width change
Time frame: up to 24 weeks
radiographic measurement
5 secondary outcomes
Changes in the height of the socket buccal and lingual ridges.
Time frame: up to 24 weeks
postoperative pain
Time frame: immediately after the procedure
Patient satisfaction
Time frame: immediately after the procedure
Keratinized tissue width
Time frame: up to 24 weeks
chair time
Time frame: immediately after the procedure
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 13 Feb 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Ridge Preservation
Not yet recruiting
Effect of Ascorbic Acid-Loaded I-PRF With Partially Demineralized Dentin Graft on Alveolar Ridge Preservation
Alveolar Ridge Preservation Post-Extraction Bone Healing Dental Implant Site Development Tooth Loss, Alveolar Bone Regeneration Following Odontectomy
Recruiting
Effect of Collagen Membrane on Ridge Preservation
Dehiscence, Tooth Extraction
Not yet recruitingPhase 1/2
Alveolar Ridge Preservation (ARP) Study Using Alloplastic Biomaterial and a Resorbable Synthetic Membrane. A Digital Workflow (CBCT/Scanner) Evaluates Hard and Soft Tissue Volumetric Changes at 4 Months, Validating Support for the Gingival Phenotype and Buccal Bone Plate.
Alveolar Ridge Augmentation, Bone Substitutes
RecruitingPhase 4
Biotivity A-C Membrane Socket Preservation Study
Alveolar Ridge Preservation
Active, not recruiting
Vallomix Socket Preservation Study
Alveolar Ridge Augmentation
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.
Odai A Hwafdeh, BDS principal investigator
Master student
Nesma M Shemais, PhD study director
Lecturer of Oral Medicine and Periodontology, Faculty of Dentistry, Cairo University
Mona S Darhous, PhD study chair
Professor of Oral Medicine and Periodontology, Faculty of Dentistry, 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 injectable platelet rich fibrin with demineralized dentin graft and demineralized dentin graft in people with Ridge Preservation and 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 6 inclusion and 6 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 13 Feb 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?
Radiographic Bucco-lingual ridge width change (time frame: up to 24 weeks). 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 Feb 2025.