The evaluation of the effect of Azithromycine on inflammatory and fibroblastic part of Cyclosporine (CsA) induced gingival overgrowth in renal transplanted patients with and without scaling
Objective: The evaluation of the effect of Azithromycine (AZM) on inflammatory and fibroblastic part of Cyclosporine (CsA) induced gingival overgrowth in renal transplanted patients with and without scaling
Design: randomised controlled clinical trial, One blinded (data analyzer)
Inclusion criteria: transplanted patients with systemic use of CsA; more than 18 year old; existing upper and lower 6 teeth of anterior segment; gingival overgrowth in grade 1 based on King Index; plaque index more than 10%
Exclusion criteria: hypersensitivity for macrolid antibiotics; not having stable renal function; having any periodontal treatment after transplantation; local irritation in Maxiillary and Mandibular anterior teeth; Oral breathing; smoking
24 patients are randomized (randomly selection numbers` Software) in 2 groups. Group1: the patients received a 5 day Azithromycine AZM regimen without scaling (two 250 milligram capsules of AZM at first day that followed with 1 capsule in 4 days). Group2: at first visit , they will be received a professional supra and subgingival scaling with ultrasonic cavitron and will be prescribed AZM (the same way as group 1) after 2 months. The results will be evaluated in weeks 4 and 8 in group1 after prescribing AZM and in weeks 4,8,12,16 in group2 .
Primary outcome variables: gingival overgrowth
Secondary outcome variables: clinical crown length; gingivitis; dental plaque; probing depth
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017040529321N2
Registration date:2017-08-15, 1396/05/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-08-15, 1396/05/24
Registrant information
Name
hamidreza baghaniaval
Name of organization / entity
sabzevar medical school
Country
Iran (Islamic Republic of)
Phone
+98 51 4465 1300
Email address
baghanih@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Kerman University Of Medical Sciences
Expected recruitment start date
2010-06-22, 1389/04/01
Expected recruitment end date
2011-06-22, 1390/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation of the effect of Azithromycine on inflammatory and fibroblastic part of Cyclosporine (CsA) induced gingival overgrowth in renal transplanted patients with and without scaling
Public title
Effect of Azithromycine (AZM) on gingival overgrowth
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: transplanted patients with systemic use of CsA; more than 18 year old; existing upper and lower 6 teeth of anterior segment; gingival overgrowth in grade 1 based on King Index; plaque index more than 10%
Exclusion criteria: hypersensitivity for macrolid antibiotics; not having stable renal function; having any periodontal treatment after transplantation; local irritation in Maxiillary and Mandibular anterior teeth; Oral breathing; smoking
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomaised Controlled Clinical Trial
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kerman University of Medical Sciences
Street address
Researches center, Tahmasbabad Crossover, Kerman
City
Kerman
Postal code
Approval date
2011-04-11, 1390/01/22
Ethics committee reference number
90/40/کا
Health conditions studied
1
Description of health condition studied
gingival enlargement
ICD-10 code
k06.1
ICD-10 code description
gingival fibromatosis
Primary outcomes
1
Description
Gingival enlargement
Timepoint
Before intervention, 4,8,12,16 weeks after intervention
Method of measurement
Periodontal probe
Secondary outcomes
1
Description
Gingivitis
Timepoint
Before intervention, 4, 8, 12, 16 weeks after intervention
Method of measurement
Observation, periodontal probe
2
Description
Dental plaque
Timepoint
Before intervention, 4, 8, 12, 16 weeks after intervention
Method of measurement
observation, plaque disclosing tablet
3
Description
Clinical crown length
Timepoint
before intervention, 4, 8, 12, 16 weeks after intervention
Method of measurement
Periodontal probe
4
Description
Probing depth
Timepoint
Before intervention, 4, 8, 12, 16 weeks after intervention
Method of measurement
periodontal probe
Intervention groups
1
Description
control:Drug
Two 250 miligram Azithromycine capsule at first day and then one 250 miligram Azithromycine capsule daily
for 4 days
Category
Treatment - Drugs
2
Description
Intervention: Scaling
Drug
Two 250 miligram Azithromycine capsule at first day and then one 250 miligram Azithromycine capsule daily
for 4 days
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Nephrology private center
Full name of responsible person
Dr.Jalal Azmandian
Street address
Kerman
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Kerman university of medical sciences
Full name of responsible person
Dr.Arash Shahravan
Street address
Researches Center, TahmasbAbad Crossover, Kerman
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, 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
Private office
Full name of responsible person
Sara beyhaghi
Position
Dentist
Other areas of specialty/work
Street address
No13, Mohaghegh7, Sabzevar, Razavi Khorasan
City
Sabzevar
Postal code
Phone
+98 51 4422 7121
Fax
Email
sara_bey2000@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman Dental School
Full name of responsible person
Mohammad Mohammadi
Position
Periodontist, Assisstant Professor
Other areas of specialty/work
Street address
Shafa St.
City
Kerman
Postal code
Phone
+98 34 3211 9021
Fax
Email
m_mohammadi@kmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Private Office
Full name of responsible person
Sara Beyhaghi
Position
Dentist
Other areas of specialty/work
Street address
No13, Mohaghegh7, Sabzevar, Razavi Khorasan
City
Sabzevar
Postal code
Phone
+98 51 4422 7121
Fax
Email
sara_bey2000@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)