NCT04967963

Brief Summary

Medication-related osteonecrosis of the jaw (MRONJ) is a drug adverse reaction and there is no consensus for the treatment of MRONJ. The aim of this study is to evaluate the mucosal coverage using HAM after sequestrectomy in patients with stage-2 MRONJ.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2020

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 18, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 20, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2022

Completed
Last Updated

April 13, 2025

Status Verified

April 1, 2025

Enrollment Period

1.7 years

First QC Date

June 18, 2021

Last Update Submit

April 9, 2025

Conditions

Medication Related Osteonecrosis of the JawOral Surgery

Keywords

Medication related osteonecrosis of the jawMRONJAmniotic membraneMucosal coverage

Outcome Measures

Primary Outcomes (1)

  • Change in mucosal coverage

    Mucosal coverage will be evaluated as "+++" for complete mucosal coverage, "++" for \>50% of mucosal coverage, "+" for \<50% of mucosal coverage, "-" for no improvement.

    12 weeks

Secondary Outcomes (2)

  • Change in Pain

    12 weeks

  • Change in suppuration and erythema as signs of infection

    12 weeks

Study Arms (1)

Transplantation of HAM

EXPERIMENTAL

HAM was used after sequestrectomy in patients with stage-2 MRONJ

Procedure: HAM

Interventions

HAMPROCEDURE

Transplantation of HAM

Transplantation of HAM

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • For Donors:
  • Free of infections such as HIV, hepatitis B and C, and syphilis before and 6 months after the cesarean section
  • Volunteers over the age of 18
  • For Recipients:
  • Medication-related osteonecrosis of the jaw cases with stage-2 diagnosis

You may not qualify if:

  • For Donors:
  • Any infection described above.
  • Mentally retarded individuals
  • For Recipients:
  • MRONJ cases with stage-1, and stage-3 diagnosis
  • Mentally retarded individuals

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Trakya University

Edirne, Merkez, 22030, Turkey (Türkiye)

Location

Related Publications (1)

  • Canakci FG, Er N, Duygu G, Varol GF. Surgical management of stage-2 medication-related osteonecrosis of the jaw with transplantation of human amniotic membrane: Preliminary results. J Stomatol Oral Maxillofac Surg. 2022 Jun;123(3):e28-e31. doi: 10.1016/j.jormas.2021.09.011. Epub 2021 Sep 23.

    PMID: 34563730DERIVED

Study Officials

  • F. Gülfeşan Çanakçi

    Trakya University, Faculty of Dentistry

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 18, 2021

First Posted

July 20, 2021

Study Start

January 15, 2020

Primary Completion

September 15, 2021

Study Completion

March 15, 2022

Last Updated

April 13, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)