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Providing a therapeutic method for regeneration of damaged bone tissue in the oral and maxillofacial region by mononuclear cells isolated from the patient's own fat tissue

Evaluation of the effect of adipose tissue - mononuclear cells (AT-NMCs) on maxillofacial bone regeneration: a randomized, controlled clinical trial and phase 1

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20181205041860N1
Enrollment
20
Registered
2019-09-26
Start date
2019-08-27
Completion date
Unknown
Last updated
2019-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with maxillofacial bone defects. Hypertrophy of bone

Interventions

Intervention 1: Intervention group: Patients with oral maxillofacial bone defect who receive autologous mononuclear cells isolated from adipose tissue with bone scaffolds (routine treatment) through o

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The patient has a bone defect in the maxillofacial region

Exclusion criteria

Exclusion criteria: The defect should not be socket, dehiscence, fenestration, and also sinus not involved. systemic and metabolic diseases active infection compromised immune system pregnant and or lactating women osteoporosis and osteopetrosis previous alveolar surgery smoking

Design outcomes

Primary

MeasureTime frame
In this study, safety is the main primary outcome. Timepoint: The patient will be visited one and six days as well as 1 and 6 months after surgery. But during this time, if patients have any abnormal clinical symptoms, you will be counseled or visited by telephone or in person. Method of measurement: To evaluate the safety, different parameters such as infection, inflammation, fibrosis tissue formation, local edema, local erythema, pain, dental implant rejection, dental sensitivity, and mortality will be evaluated through clinical evaluations, blood tests, CT scans Conical scans and scatological analyzes.

Secondary

MeasureTime frame
New bone formation. Timepoint: after 6 months from surgery. Method of measurement: analysis of Cone Beam-CT data and histology images.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahboubeh Bohlouli

Shahid Beheshti University of Medical Sciences

bohlouli98@gmail.com+98 21 2243 9847

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026