1)Objectives: To evaluate the effects of micro- spherical minocycline on the clinical and cytokine profile of peri-imlant inflammatory diseases.
(2) Design: Evaluation of non- superiority of the proposed treatment protocol with a double-blind, two-arm parallel-group design.
(3) Setting and conduct: The patients who will be recalled to follow-up visits during March - September 2014 at Periodontics Department of Faculty of Dentistry and private practice offices in Tabriz- Iran.
(4) Participants' including major eligibility criteria : Adult patients with at least one implant in function for more than one year with peri-imlant inflammatory diseases defined as: Presence of Bleeding on probing, with radio-graphic bon loss less than 2 mm and probing depth equal or more than 4 mm in at least one site.
(5) Intervention: 25 patients will be recruited for each arm of this trial. Baseline sampling and clinical measurements will be recorded and randomly assigned to receive one of the following treatment protocols: Mechanical debridement using ultrasonic scaler and air-powder polishing device. Mechanical debridement along with one mg of minocycline hydrochloride microspheres will be inserted subgingivally into the affected sites. Clinical data including probing depth (PD), bleeding on probing (BOP), interleukin 6 and 17 in gingival crevicular fluid (GCF) will be assessed at baseline, 2 weeks and 3-months after treatments.
(6) Main outcome measures: The primary outcome considered as BOP changes and secondary outcomes will be PD and IL-6, 17 level changes in GCF.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013100114847N1
Registration date:2014-01-25, 1392/11/05
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-01-25, 1392/11/05
Registrant information
Name
Zaker Yari Hajatalou
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 5965
Email address
rpourabbas@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Tabriz University of Medical Sciences
Expected recruitment start date
2014-03-27, 1393/01/07
Expected recruitment end date
2014-08-23, 1393/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Sustained release of micro- spherical minocycline for management of peri-implant mucosal inflammation
Public title
Local antibiotic therapy in peri- implant inflammation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1) Adults aged 18 or over with at least one implant in function for more than one year
2) Mild peri-imlant inflammatory diseases. defined as: presence of Bleeding on Probing, radio-graphic bon loss at the site of the implant less than 2 mm and probing depth more than 4 mm
Exclusion criteria:
1) Any related systemic diseases
2) Smoking
3) Pregnancy and lactation
4) Active periodontal disease
5) Consumption of systemic antibiotics in the late 3 months
6) Need for bacterial prophylaxis with systemic antibiotics
7) Long-term use of any drug affects periodontal tissue conditions
8) Probing depth greater than 6 mm at base line visit
9) Drug and alcohol abuse
10) Uncontrolled diabetes
11) Probing depth less than 4 mm at base line visit
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University Of Medical Sciences
Street address
Department of periodontics, School of Dentistry, Tabriz University of Medical Sciences, Golgasht Street
City
Tabriz
Postal code
Approval date
2013-08-01, 1392/05/10
Ethics committee reference number
9268
Health conditions studied
1
Description of health condition studied
Periimplantitis
ICD-10 code
T85.8
ICD-10 code description
Other complications of internal prosthetic devices, implants and grafts, not elsewhere classified
Primary outcomes
1
Description
Bleeding on probing (BOP)
Timepoint
Baseline, 2 week and 3 month later
Method of measurement
Periodontal Probe
Secondary outcomes
1
Description
Peri implant probing depth
Timepoint
Baseline, after 2 weeks, after 3 month
Method of measurement
Periodontal prob
2
Description
cytokines level in gingival crevicular fluid (GCF): IL-6, IL-17
Timepoint
Baseline, 2 week and 3 month later
Method of measurement
ELISA test
Intervention groups
1
Description
Control group: Mechanical debridement using ultrasonic scaler and air-powder air polishing device.
Category
Treatment - Devices
2
Description
Intervention: Two weeks after mechanical debridement, a one mg of minocycline hydrochloride microspheres introduced subgingivally into the affected sites.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry, Tabriz University of Medical Sciences
Full name of responsible person
Reza Pourabbas (Periodontist, Professor)
Street address
Department of periodontics, School of Dentistry, Tabriz University of Medical Sciences, Golgasht Street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Tabriz University of Medical Sciences
Full name of responsible person
Reza Porabbas (Professor)
Street address
Department of periodontics, School of Dentistry, Tabriz University of Medical Sciences, Golgasht Street
City
Tabriz
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 of Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Reza Pourabbas
Position
Periodontics/ Professor
Other areas of specialty/work
Street address
Department of periodontics, School of Dentistry, Tabriz University of Medical Sciences, Golgasht Street
City
Tabriz
Postal code
Phone
+98 41 1335 5965
Fax
Email
rpourabbas@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Reza Pourabbas
Position
Periodontics/ Professor
Other areas of specialty/work
Street address
Department of periodontics, School of Dentistry, Tabriz University of Medical Sciences, Golgasht Street
City
Tabriz
Postal code
Phone
+98 41 1335 5965
Fax
Email
rpourabbas@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Zaker Yari Hajatalou
Position
DDS/ periodontics resident
Other areas of specialty/work
Street address
Department of periodontics, School of Dentistry, Tabriz University of Medical Sciences, Golgasht Street
City
Tabriz
Postal code
Phone
+98 41 1335 5965
Fax
Email
zakeryari@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)