Protocol summary

Summary
arch bar is the most predictable way to manage maxillofacial fracture but it has some complications. wires cause plaque accumulation and also oral hygiene control is challenging because of circum dental wiring, arch bar and gingival ulcers. these problems cause gingivitis, mal odor during the arch bar treatment. Therefore, in this study we are adding periodically removal of plaque with subgingival washing by jet irrigator during fracture treatment, and evaluate its impact on reducing harmful effect of Arch Bar on Preiodontiom such as gingival ulcers, malodor (which is a common complaint of patients), and increased tooth mobility and pocket depth. According to the same articles, sample size is 60 patients. patients with mandibulomaxillary or dentoalveollar fracture and are referred to maxillofacial ward of bahonar hospital are selected. Patients who have treatment plan that is include open reduction and fixation with 10 days intermaxillary fixation (IMF) are remain in the study. patients will be devided in two groups (A, B)with even and odd method.A clinician to perform an initial check and supplementary examinations will be trained. Patients will be examined before surgery by this clinicians who is blind to this research (the probing depth and panoramic radiography will be done).oral Health care recommendations for all patients during treatment will be carried out. patients in group A will have sub gingival irrigation with chlorhexydine 2 times a week and dental care recommendation. patient in group B will have only oral hygiene recommendation. after 2mounth arch bar will be removed and these examination will be done for the patients with the clinician that the primary examination had done by him and is blind to this research: 1- tooth mobility 2- plaque index 3- gingival index 4- extended and severity index

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017032232354N2
Registration date: 2017-06-28, 1396/04/07
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-06-28, 1396/04/07
Registrant information
Name
Sorena Fardisi
Name of organization / entity
Kerman University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 32123965
Email address
s.fardisi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Kerman University of Medical Science
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2018-04-22, 1397/02/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of complementary subgingival irrigation on the periodontail health in the management of jaw and dentoalveolar fracture using arch bar and dentoalveolar wiring
Public title
Evaluation of complementary subgingival irrigation on the لهدلهرشمl health in the management of jaw fracture using dentoalveolar wiring
Purpose
Supportive
Inclusion/Exclusion criteria
inclusion criteria: patient are selected from whom that have mandibular or maxillary fracture and referred to maxillofacial ward of bahonar hospital. exclusion criteria: patient who are not dentated in upper and lower jaws that arch bar treatment was done; patient with periodontiitis; their treatment plan is not included open reduction rigid fixation and 10 days intermaxillary fixation with arch bar
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
kerman University of Medical Sciences
Street address
Dental school, Shafa street
City
Kerman
Postal code
00987618759689
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
IR.KMU.REC.1395.759

Health conditions studied

1

Description of health condition studied
periodontitis
ICD-10 code
k05.4
ICD-10 code description
periodontosis

Primary outcomes

1

Description
dental mobility
Timepoint
after arch bar removal
Method of measurement
colis

2

Description
gigiva inflimation
Timepoint
after arch bar removal
Method of measurement
gingival index loe and silness

3

Description
plaque aqumilation
Timepoint
after arch bar removal
Method of measurement
plaque index silnessand loe

4

Description
periodontitis
Timepoint
after arch bar removal
Method of measurement
ESI index

Secondary outcomes

empty

Intervention groups

1

Description
oral hygien recommendation and subgingival irrigation during fracture treatment
Category
Prevention

2

Description
oral hygiene recommendation in the control group during the fracture treatment
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Bahonar hospital
Full name of responsible person
Dr Sorena Fardisi
Street address
Shariatee Street
City
Kerman

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr Sorena Fardisi
Street address
Kerman
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr Sorena Fardisi
Position
Maxillofacial surgeon
Other areas of specialty/work
Street address
Dentistry School
City
Kerman
Postal code
Phone
+98 34 3212 3965
Fax
+98 34 3211 8073
Email
sorenafardisi@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr Sorena Fardisi
Position
Maxillofacial surgeon
Other areas of specialty/work
Street address
Dentistry School
City
Kerman
Postal code
Phone
+98 34 3212 3965
Fax
+98 34 3211 8073
Email
s.fardisi@kmu.ac.irsorenafardisi@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr Sorena Fardisi
Position
Maxillofacial surgeon
Other areas of specialty/work
Street address
Dentistry School
City
Kerman
Postal code
Phone
+98 34 3212 3965
Fax
+98 34 3211 8073
Email
s.fardisi@gmail.comsorenafardisi@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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