Protocol summary

Study aim
This study aimed to evaluate the effect on clinical healing of a combined treatment consisting of laser-assisted surgery and Platelet rich plasma (PRP) in cancer patients affected by bisphosphonates related osteonecrosis of the jaw (BRONJ)
Design
Cancer patients affected by BRONJ, single arm, not randomized
Settings and conduct
1) Clinical Evaluation; 2) Computer Tomography (CT) evaluation; lesions’ classification following SIPMO-SICMF staging system; scaling (when required) and oral hygiene instructions; pre-operatory medical therapy prescription; Platelet rich-plasma (PRP) preparation; 3) Surgical procedure: Er,Cr:YSGG Laser surgery, PRP application,Flap suture; 4) Suture removal and clinical control; 5) Follow-up visits at 15 days, one month, three, six, twelve months;
Participants/Inclusion and exclusion criteria
Patients were eligible for the study if they had: 1) age ≥ 18 years; 2) cancer; 3) treatment with bisphosphnates (BPs) because of the underlying cancer. Patients were excluded from the study if they had: 1): previous history of irradiation to the maxillofacial area; 2) neoplastic involvement of the jaws; 3) previous surgical treatment to the jaws; 4) poor general conditions.
Intervention groups
The surgical protocol consisted of: 1) elevation of a full-thickness mucoperiosteal flap to expose the surgical area; 3) bony curettage (debridement) and sequestrectomy of the necrotic bone, whether required, using a Er,Cr:YSGG laser; 4) application of autologous PRP; 5) tension-free soft tissue closure
Main outcome variables
We defined successful treatment the absence of clinical and radiological signs of BRONJ relapse (healing) or, in turn, the transition from a higher stage to a lower one (improvement).

General information

Reason for update
Acronym
ErPRP
IRCT registration information
IRCT registration number: IRCT20180329039159N1
Registration date: 2018-06-12, 1397/03/22
Registration timing: retrospective

Last update: 2018-06-12, 1397/03/22
Update count: 0
Registration date
2018-06-12, 1397/03/22
Registrant information
Name
Rodolfo Mauceri
Name of organization / entity
University of Palermo
Country
Italy
Phone
+39 091 655 2221
Email address
rodolfo.mauceri@unipa.it
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2014-01-01, 1392/10/11
Expected recruitment end date
2015-12-31, 1394/10/10
Actual recruitment start date
2015-06-10, 1394/03/20
Actual recruitment end date
2015-11-02, 1394/08/11
Trial completion date
empty
Scientific title
Conservative surgical treatment of bisphosphonate-related osteonecrosis of the jaw with Er,Cr:YSGG laser and platelet-rich plasma in cancer patients
Public title
Er,Cr:YSGG laser and platelet-rich plasma in treatment of ONJ
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age ≥ 18 years cancer; treatment with BPs because of the underlying cancer
Exclusion criteria:
previous history of irradiation to the maxillofacial area neoplastic involvement of the jaws previous surgical treatment to the jaws poor general conditions
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 10
Actual sample size reached: 10
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Comitato Etico Palermo 1
Street address
Via del Vespro 129
City
Palermo
Postal code
90127
Approval date
2015-06-10, 1394/03/20
Ethics committee reference number
6/2015

Health conditions studied

1

Description of health condition studied
Bisphosphonates related osteonecrosis of the jaw
ICD-10 code
M87.1
ICD-10 code description
Osteonecrosis due to drugs

Primary outcomes

1

Description
Absence of clinical and radiological signs of BRONJ relapse (healing) or, in turn, the transition from a higher stage to a lower one (improvement).
Timepoint
We scheduled follow-up visits to remove the suture seven days after surgery, and visited patients on the fifteenth day, and continued on month one, three, six and twelve
Method of measurement
Clinical and radiological signs

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group; the surgical protocol consisted of: 1) elevation of a full-thickness mucoperiosteal flap to expose the surgical area; 3) bony curettage (debridement) and sequestrectomy of the necrotic bone, whether required, using a Er,Cr:YSGG laser; 4) application of autologous platelet rich plasma (PRP); 5) tension-free soft tissue closure
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Department of Surgical, Oncological and Oral Sciences, University of Palermo
Full name of responsible person
Prof. Giuseppina Campisi
Street address
Via del Vespro 129
City
Palermo
Postal code
90127
Phone
+39 091 655 2221
Email
campisi@odonto.unipa.it

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
None
Full name of responsible person
None
Street address
via del vespro 129
City
Palermo
Postal code
90127
Email
campisi@odonto.unipa.it
Grant name
Not applicable
Grant code / Reference number
Not applicable
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
None
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
University of Palermo
Full name of responsible person
Giuseppina Campisi
Position
Full Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
via del vespro 129
City
Palermo
Province
Palermo
Postal code
90127
Phone
+39 091 655 2236
Email
campisi@odonto.unipa.it

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Palermo
Full name of responsible person
Giuseppina Campisi
Position
Full Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Via del Vespro 129
City
Palermo
Province
Palermo
Postal code
90127
Phone
+39 091 655 2236
Email
campisi@odonto.unipa.it

Person responsible for updating data

Contact
Name of organization / entity
University of Palermo
Full name of responsible person
Rodolfo Mauceri
Position
Tutor
Latest degree
Ph.D.
Other areas of specialty/work
Dentistry
Street address
Via m.se di villabianca 24
City
Palermo
Province
Palermo
Postal code
90143
Phone
+39 091 655 2221
Email
rodolfo.mauceri@unipa.it

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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