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Effect of platelet-rich plasma (PRP) on dental extraction in patients at risk of medication related osteonecrosis of the jaw

Protocol summary

Study aim
The aim of this study was to assess the efficiency, as clinical healing, of the application of platelet-rich plasma (PRP) gel in the extraction sockets in patients treated with bisphosphonates at risk of medication-related osteonecrosis of the jaw (MRONJ)
Design
single center, single-arm not randomized clinical trial
Settings and conduct
1) Clinical Evaluation 2) Computer Tomography (CT) evaluation if needed; oral hygiene instructions; pre-operatory medical therapy prescription; PRP preparation 3) Surgical procedure 4) Suture removal 5) Follow-up visits at 15, 30, 90, 180, 360 days
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1) age > 18 years 2) metabolic bone disease and/or malignant tumors 3) treatment with bisphosphonates because of the underlying disease 4) required tooth extraction Exclusion criteria: 1) signs of MRONJ in the surgical area 2) previous history of irradiation to the head and neck area 3) neoplastic involvement of the jaws 4) poor general conditions 5) pregnant or breast-feeding women
Intervention groups
The surgical protocol expected: 1)Chlorhexidine 0,2% mouthwashes 30 ml swished up to 60 seconds 2) local anesthesia achieved using 3% mepivacaine hydrochloride without adrenaline 3) elevation of a full-thickness mucoperiosteal flap 4) tooth luxation and avulsion 5) if necessary, osteoplasty 6) debridement of the post-extraction socket and irrigation with rifamycin sodium 7) application of a single dosage of autologous PRP (Plateltex ACT System ®, Biomed, Modena, IT) 8) suture. To prepare the PRP and to induce its gelation, the materials provided by the manufacturer were used and the provided instructions followed [Mazzucco L, Balbo V, Cattana E, Borzini P. Platelet-rich plasma and platelet gel preparation using Plateltex. Vox Sang. 2008 Apr;94(3):202-8.]
Main outcome variables
Absence of signs related to MRONJ (Healing)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180329039159N2
Registration date: 2019-08-05, 1398/05/14
Registration timing: retrospective

Last update: 2019-08-05, 1398/05/14
Update count: 0
Registration date
2019-08-05, 1398/05/14
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
2015-06-10, 1394/03/20
Expected recruitment end date
2016-06-30, 1395/04/10
Actual recruitment start date
2015-06-10, 1394/03/20
Actual recruitment end date
2016-04-30, 1395/02/11
Trial completion date
2016-04-30, 1395/02/11
Scientific title
Effect of platelet-rich plasma (PRP) on dental extraction in patients at risk of medication related osteonecrosis of the jaw
Public title
Effect of PRP to prevent MRONJ after dental extraction
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
metabolic bone disease and/or malignant tumors treatment with bisphosphonates because of the underlying disease required tooth extraction
Exclusion criteria:
clinical or radiological signs of medication related osteonecrosis of the jaw in the surgical area previous history of irradiation to the head and neck area neoplastic involvement of the jaws poor general conditions pregnant or breast-feeding women
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 20
Actual sample size reached: 20
Randomization (investigator's opinion)
N/A
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
Palermo Ethics Committee 1
Street address
129 Via del Vespro
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
medication related osteonecrosis of the jaw
ICD-10 code
m87.1
ICD-10 code description
Osteonecrosis due to drugs

Primary outcomes

1

Description
Absence of signs related to MRONJ (Healing)
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 expected: 1) Chlorhexidine 0,2% mouthwashes 30 ml swished up to 60 seconds; 2) local anesthesia achieved using 3% mepivacaine hydrochloride without adrenaline; 3) elevation of a full-thickness mucoperiosteal flap; 4) tooth luxation and avulsion were gently performed with elevators and forceps; 5) if necessary, osteoplasty 6) debridement of the post-extraction socket with miller surgical curette and irrigation of the sockets with rifamycin sodium; 7) application of a single dosage of autologous platelet-rich plasma (Plateltex ACT System ®, Biomed, Modena, IT) ; 8) tension-free soft tissue closure. To prepare the PRP and to induce its gelation, the materials provided by the manufacturer were used and the provided instructions followed [Mazzucco L, Balbo V, Cattana E, Borzini P. Platelet-rich plasma and plateletgel preparation using Plateltex. Vox Sang. 2008 Apr;94(3):202-8.]
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
129 Via del Vespro
City
Palermo
Postal code
90127
Phone
+39 091 655 2221
Email
campisi@odonto.unipa.it

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of Palermo
Full name of responsible person
Prof. Giusepina Campisi
Street address
129 Via del Vespro
City
Palermo
Postal code
90127
Phone
+39 091 655 2221
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
University of Palermo
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
129 Via del Vespro
City
Palermo
Province
Sicily
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
Rodolfo Mauceri
Position
Tutor
Latest degree
Ph.D.
Other areas of specialty/work
Dentistry
Street address
7 Via Benedetto Civiletti
City
Palermo
Province
Palermo
Postal code
90141
Phone
+39 091 655 2221
Email
rodolfo.mauceri@unipa.it

Person responsible for updating data

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
129 Via del Vespro
City
Palermo
Province
Palermo
Postal code
90127
Phone
+39 091 655 2236
Email
campisi@odonto.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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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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