PRP & Jaw CystsNCT06721806
Role of Platelet Rich Plasma in Bone Regeneration After Enucleation of Odontogenic Jaw Cysts
A study testing PRP & bone regeneration in people with PRP & Jaw Cysts, run by Assiut University.
Trial summary
in the present study, the effect of PRP on bone regeneration when applied to the site of removal of cyst of the jaws is evaluated. PRP was delivered to the site combined with gelfoam. Thrombin clot accelerator was not used. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- PRP & Jaw Cysts
- What is being tested?
- PRP & bone regeneration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Dec 2024to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Size of the cyst more than 2 cm
- The lesion could be visualized radiographically
- Patients within the age range of 20 to 50 years
Who cannot join
- Patients who were alcoholics \& smokers
- -Patients with systemic diseases
- History of bleeding tendencies, blood dyscrasia
- Low platelet count
- Patients unable or unwilling to return for follow-up
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Samy Masoud, prof .dr contact
About this study
in the present study, the effect of PRP on bone regeneration when applied to the site of removal of cyst of the jaws is evaluated. PRP was delivered to the site combined with gelfoam. Thrombin clot accelerator was not used.
Read the detailed description
Jaw cysts are common lesions in the oral and maxillofacial region. Enucleation of cyst wall \& curettage has evolved as the treatment of choice. In order to reduce infections and to accelerate bone regeneration, by using of Platelet rich plasma.
Platelets are involved in regeneration at sites of pathology, apart from their role in clotting. A preparation composed mainly of platelets (platelet-rich plasma gel) applied to sites of bony pathology, after surgical treatment of lesions, may hasten bone regeneration.
An interesting idea developed that the addition of a concentrate of platelets, to wounded tissues or surgical sites, may enhance the body's natural wound healing mechanisms . Platelet-rich plasma (PRP) is the accepted term to describe the preparation made out of autologous platelets suspended in autologous plasma, in concentration greater than normally found in peripheral blood Because it is autologous, PRP avoids the risk of transmissible diseases such as HIV, Hepatitis B, C or D and other blood-borne pathogens .A clot accelerator such as bovine thrombin is added to gel the PRP or PRP is added to other materials such as collagen, gelfoam, etc.
- Conditions
- PRP & Jaw Cysts
- Being tested
- PRP & bone regeneration
- Medical subject headings
- Jaw Cysts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRP & bone regenerationProcedure or surgery
PRP effect on bone healing
| Study group | Role | What they receive |
|---|---|---|
| PRP and bone regeneration after enucleation of odontogenic jaw cysts | Active comparator | effect of PRP on regeneration Receives: Procedure: PRP & bone regeneration |
| bone regeneration power without PRP | Placebo comparator | bone healing without use of PRP Receives: Procedure: PRP & bone regeneration |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone healing
effect of PRP in bone healing by measuring bone density
Measured: 6 months
PRP & infection rate
PRP reduce infection rate
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 posted6 Dec 2024
- Study startDec 2024 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for PRP & Jaw CystsStudies of the same condition, open and under way.
- More trials run by Assiut 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
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maikel Merit Gerges Morkos, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06721806
- Sponsor's protocol ID
- PRP & bone healing
- Status last verified
- Dec 2024
- First submitted
- 5 Nov 2024
- Last updated
- 6 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tiwari A. A Traumatic Ulcer Caused by Accidental Lip Biting Following Topical Anesthesia: A Case Report. Cureus. 2023 Apr 29;15(4):e38316. doi: 10.7759/cureus.38316. eCollection 2023 Apr.
PubMed 37261171Dohan DM, Choukroun J, Diss A, Dohan SL, Dohan AJ, Mouhyi J, Gogly B. Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part I: technological concepts and evolution. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Mar;101(3):e37-44. doi: 10.1016/j.tripleo.2005.07.008. Epub 2006 Jan 19.
PubMed 16504849Dohan DM, Choukroun J, Diss A, Dohan SL, Dohan AJ, Mouhyi J, Gogly B. Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part II: platelet-related biologic features. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Mar;101(3):e45-50. doi: 10.1016/j.tripleo.2005.07.009. Epub 2006 Jan 10.
PubMed 16504850Intini G. The use of platelet-rich plasma in bone reconstruction therapy. Biomaterials. 2009 Oct;30(28):4956-66. doi: 10.1016/j.biomaterials.2009.05.055. Epub 2009 Jul 1.
PubMed 19573909Rathore A, Tiwari A, Nazim M, Gupta AK, Gande M, Krishnakumar J. Detection of Human PapillomaVirus and its Association with Potentially Malignant Disorders and Oral Squamous Cell Carcinoma: A Retrospective Study. J Pharm Bioallied Sci. 2022 Jul;14(Suppl 1):S820-S824. doi: 10.4103/jpbs.jpbs_9_22. Epub 2022 Jul 13.
PubMed 36110657Raghavendra KM, Sara TB, Mariam VJ, Bhat GS. Author's reply: Platelet-rich fibrin as an adjunct to palatal wound healing after harvesting a free gingival graft: A case series. J Indian Soc Periodontol. 2014 Nov-Dec;18(6):684-5. doi: 10.4103/0972-124X.147397. No abstract available.
PubMed 25624621Kulkarni MR, Thomas BS, Varghese JM, Bhat GS. Platelet-rich fibrin as an adjunct to palatal wound healing after harvesting a free gingival graft: A case series. J Indian Soc Periodontol. 2014 May;18(3):399-402. doi: 10.4103/0972-124X.134591.
PubMed 25024559
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Platelet Rich Plasma in Bone Regeneration After Enucleation of Odontogenic Jaw Cysts
- ClinicalTrials.gov ID
- NCT06721806
- Acronym / sponsor ID
- PRP & bone healing
- Conditions
- PRP & Jaw Cysts
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2024 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 6 Dec 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.
in the present study, the effect of PRP on bone regeneration when applied to the site of removal of cyst of the jaws is evaluated. PRP was delivered to the site combined with gelfoam. Thrombin clot accelerator was not used.
Detailed description
Jaw cysts are common lesions in the oral and maxillofacial region. Enucleation of cyst wall \& curettage has evolved as the treatment of choice. In order to reduce infections and to accelerate bone regeneration, by using of Platelet rich plasma.
Platelets are involved in regeneration at sites of pathology, apart from their role in clotting. A preparation composed mainly of platelets (platelet-rich plasma gel) applied to sites of bony pathology, after surgical treatment of lesions, may hasten bone regeneration.
An interesting idea developed that the addition of a concentrate of platelets, to wounded tissues or surgical sites, may enhance the body's natural wound healing mechanisms . Platelet-rich plasma (PRP) is the accepted term to describe the preparation made out of autologous platelets suspended in autologous plasma, in concentration greater than normally found in peripheral blood Because it is autologous, PRP avoids the risk of transmissible diseases such as HIV, Hepatitis B, C or D and other blood-borne pathogens .A clot accelerator such as bovine thrombin is added to gel the PRP or PRP is added to other materials such as collagen, gelfoam, etc.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRP and bone regeneration after enucleation of odontogenic jaw cysts | Active comparator | Procedure: PRP & bone regenerationeffect of PRP on regeneration |
| bone regeneration power without PRP | Placebo comparator | Procedure: PRP & bone regenerationbone healing without use of PRP |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Size of the cyst more than 2 cm
- The lesion could be visualized radiographically
- Patients within the age range of 20 to 50 years
Key exclusion criteria (5 listed)
- Patients who were alcoholics \& smokers
- -Patients with systemic diseases
- History of bleeding tendencies, blood dyscrasia
- Low platelet count
- Patients unable or unwilling to return for follow-up
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 |
|---|---|---|
| PRP & bone regenerationPRP effect on bone healing | Procedure or surgery | PRP and bone regeneration after enucleation of odontogenic jaw cysts, bone regeneration power without PRP |
Primary outcome
bone healing
Time frame: 6 months
effect of PRP in bone healing by measuring bone density
PRP & infection rate
Time frame: 6 months
PRP reduce infection rate
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Background: PubMed 37261171Tiwari A. A Traumatic Ulcer Caused by Accidental Lip Biting Following Topical Anesthesia: A Case Report. Cureus. 2023 Apr 29;15(4):e38316. doi: 10.7759/cureus.38316. eCollection 2023 Apr.
- Background: PubMed 16504849Dohan DM, Choukroun J, Diss A, Dohan SL, Dohan AJ, Mouhyi J, Gogly B. Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part I: technological concepts and evolution. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Mar;101(3):e37-44. doi: 10.1016/j.tripleo.2005.07.008. Epub 2006 Jan 19.
- Background: PubMed 16504850Dohan DM, Choukroun J, Diss A, Dohan SL, Dohan AJ, Mouhyi J, Gogly B. Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part II: platelet-related biologic features. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Mar;101(3):e45-50. doi: 10.1016/j.tripleo.2005.07.009. Epub 2006 Jan 10.
- Background: PubMed 19573909Intini G. The use of platelet-rich plasma in bone reconstruction therapy. Biomaterials. 2009 Oct;30(28):4956-66. doi: 10.1016/j.biomaterials.2009.05.055. Epub 2009 Jul 1.
- Background: PubMed 36110657Rathore A, Tiwari A, Nazim M, Gupta AK, Gande M, Krishnakumar J. Detection of Human PapillomaVirus and its Association with Potentially Malignant Disorders and Oral Squamous Cell Carcinoma: A Retrospective Study. J Pharm Bioallied Sci. 2022 Jul;14(Suppl 1):S820-S824. doi: 10.4103/jpbs.jpbs_9_22. Epub 2022 Jul 13.
- Background: PubMed 25624621Raghavendra KM, Sara TB, Mariam VJ, Bhat GS. Author's reply: Platelet-rich fibrin as an adjunct to palatal wound healing after harvesting a free gingival graft: A case series. J Indian Soc Periodontol. 2014 Nov-Dec;18(6):684-5. doi: 10.4103/0972-124X.147397. No abstract available.
- Background: PubMed 25024559Kulkarni MR, Thomas BS, Varghese JM, Bhat GS. Platelet-rich fibrin as an adjunct to palatal wound healing after harvesting a free gingival graft: A case series. J Indian Soc Periodontol. 2014 May;18(3):399-402. doi: 10.4103/0972-124X.134591.
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.
Samy Masoud, prof .dr contact
Questions about this trial
What is this clinical trial studying?
A study testing PRP & bone regeneration in people with PRP & Jaw Cysts, run by Assiut University.
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 5 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: opening soon, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maikel M G Morkos, dr (+201271267725, Michael.16266363@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bone healing (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT06721806, which also lists 7 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 6 Dec 2024.