Effect of Buccal Fat Pad Derived Stem Cells in Maxillary Sinus Augmentation

NCT02745379 | Unknown Phase 1

• 1 other identifier: sbmu9212
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

In this study the buccal fat pad derived stem cells (BFPSCs) will be harvested from buccal fat pad tissue of patients receiving maxillary sinus augmentation. In the test group the patients receive a combination of platelet rich fibrin (PRF) and freeze dried bone allograft (FDBA) (SureOss, Hansbiomed, Korea) loaded with BFPSCs. The results will be evaluated by cone beam computed tomography (CBCT)and hematoxylin and eosin staining in 6 months.

Conditions

Alveolar Bone Loss

Outcome Measures

Primary Outcomes (2)

• amount of regenerated bone

  the amount of regenerated bone will be assessed by Image Pro software in CBCT images

  6 months

• amount of regenerated bone

  the percent of regenerated bone will be assessed on bone biopsies obtained during implant insertion by H\&E staining by microscope

  6 months

Study Arms (2)

BFPSC+

EXPERIMENTAL

The group receives a combination (DFDBA)+buccal fat pad derived stem cells BFPSC and PRF for sinus augmentation

Procedure: BFPSCs+ DFDBA+ PRF

BFPSC-

ACTIVE COMPARATOR

The group receives a combination of demineralized freeze-dried bone allografts DFDBA (lacking any cells) and PRF for sinus augmentation

Procedure: DFDBA + PRF

Interventions

BFPSCs+ DFDBA+ PRF PROCEDURE

BFPSC+

DFDBA + PRF PROCEDURE

BFPSC-

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with posterior maxillary edentulism
• pneumatized sinus
• less than 5mm bone height between the alveolar crest and sinus membrane

You may not qualify if:

• smoking
• history of malignancy
• radiation
• chemotherapy
• pregnancy
• systemic diseases contradicting dental and surgical treatments
• conditions or drugs affecting bone remodeling or bone metabolism and connective tissue
• allergy to collagen

Sponsors & Collaborators

• Shahid Beheshti University of Medical Sciences: lead

Study Sites (1)

School of Dentristry at Shahid Beheshti University of Medical Sciences

Tehran, Tehran Province, 19839, Iran

RECRUITING

MeSH Terms

Conditions

Alveolar Bone Loss

Interventions

Prolactin-Releasing Hormone

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Arash Khojasteh, DMD, OMFS

  Shahid Beheshti University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arash Khojasteh, DMD, OMFS

CONTACT

00989121060032; arashkhojasteh@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: April 18, 2016
• First Posted: April 20, 2016
• Study Start: January 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: October 17, 2016

Record last verified: 2016-10

Locations

IR (1)