Effect of Adipose Tissue Derived Autologous Mesenchymal Stem Cell Concentrate on Bone Quality in Mandibular Fracture Healing.
25. juni 2026 opdateret af: Mona Mahmoud Abdulhameed, Cairo University
Bone Quality Assessment Following Application of Adipose Tissue Derived Autologous Mesenchymal Stem Cell Concentrate in the Management of Mandibular Fractures. A Randomized Clinical Trial
- The goal of study is to evaluate the effectiveness of adipose tissue derived-MSCs concentrate application in mandibular fractures. The main question it aims to answer is: Does intervention enhance bone quality, reduce complications and reduce bone regeneration time.
- Researchers will compare the effectiveness of adipose tissue derived-MSCs concentrate application with ORIF to ORIF alone to see if MSCs improve healing in mandibular fractures.
Participants will:
- Be managed either by adipose tissue derived-MSCs concentrate application with ORIF or ORIF alone.
- Undergo CBCT immediately (T1) and 3 months (T4) postoperatively for bone density radiographic evaluation
- Visit the clinic postoperatively at one week (T2), one month (T3), three months (T4) for clinical examination
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Detaljeret beskrivelse
- From oral and maxillofacial surgery outpatient clinic, Faculty of Dentistry, Cairo University. 20 patients will be included in this study, the patients will be randomly distributed into two groups each containing 10 patients, one group will be treated by application of adipose tissue derived autologous mesenchymal stem cell concentrate before and after fixation and the other group will be treated by fixation only without application of adipose tissue derived autologous mesenchymal stem cell concentrate.
- All surgeries (for study and control groups) will be carried out with endotracheal intubation under general anaesthesia.
- After scrubbing the surgical field with a povidone-iodine surgical scrub solution, the patients will be draped in sterile towels such that only the surgical site will be visible.
- The fracture line will be exposed, followed by mobilization of the fracture, and removal of any soft tissue entrapped within the fracture line. Intermaxillary fixation (IMF) will be done and temporarily secured to provide proper occlusion that will serve as a guide for fracture reduction.
- The reduction of the bone into appropriate anatomical occlusion will then be visually verified by confirming that the mandible is properly aligned. After that, the titanium plate is positioned and secured with titanium screws.
- For the study group, abdominal lipo- suction will be carried out for the subsequent receive and gain of fat-derived stem cells following the microfragmentation of adipose tissue. This lipo-aspirate containing MSCs will be applied on fracture line before and following fixation.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
20
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Mona Mahmoud Abdulhameed
- Telefonnummer: 00201001249384
- E-mail: monamabdulhameed@gmail.com
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- Patients with mandibular fracture.
- Patients who are willing to participate in the study
Exclusion Criteria:
- Patients with systemic diseases influence bone healing
- Patients with pathological fractures.
- Infection located at the zone to be treated
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Study group
10 patients with mandibular fracture will be treated by application of adipose tissue derived MSCs concentrate on fracture line before and following fixation with titanium plates and screws.
|
Abdominal fat liposuction will be carried out, microfragmentation of adipose tissue will be performed.
Then the filtrate containing mesenchymal stem cells concentrate will be applied to the fracture line before and following fixation with titanium plates and screws .
|
|
Aktiv komparator: Control group
10 patients with mandibular fracture will be treated by open reduction and internal fixation with titanium plates and screws.
|
Open reduction and internal fixation of fracture line with titanium plates and screws
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Bone density
Tidsramme: 3 months
|
Assessment of bone density at fracture healing site by CBCT
|
3 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Soft tissue dehiscence
Tidsramme: 3 month
|
Detection of soft tissue dehiscence occurrence (Binary: Yes/ No)
|
3 month
|
|
Bleeding
Tidsramme: 3 months
|
Detection of bleeding occurrence (Binary: Yes/ No)
|
3 months
|
|
Infection
Tidsramme: 3 months
|
Detection of Infection occurrence (Binary: Yes/ No)
|
3 months
|
|
Malocclusion
Tidsramme: 3 months
|
Detection of malocclusion occurrence (Binary: Yes/ No)
|
3 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studiestol: Mostafa Mohamed El-Gangehi, Professor, Faulty of Dentistry, Cairo University
- Studieleder: Walaa Kadry, Associate Professor, Faulty of Dentistry, Cairo University
- Studiestol: Sameh Mekhemer, Professor, Faulty of Dentistry, Cairo University
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. juli 2026
Primær færdiggørelse (Anslået)
1. februar 2027
Studieafslutning (Anslået)
1. februar 2027
Datoer for studieregistrering
Først indsendt
22. juni 2026
Først indsendt, der opfyldte QC-kriterier
22. juni 2026
Først opslået (Faktiske)
26. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
29. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
25. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 3319
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