Protocol summary

Summary
Objective: Evaluation of effects of simvastatin gel in combination with allograft on improvement of clinical parameters and bone fill in furcation involvement grade II mandibular molars compared to allograft alone. This randomized clinical trial is double blind and accomplished on ten patients with chronic periodontitis. Inclusion criteria: a pair of first or second mandibular teeth bilaterally with furcation involvement class II that have at least 3 mm horizontal penetration of probe in furca. At least 2 mm keratinized gingiva. Exclusion criteria: smoking; history of systemic disease; pregnant or breast feeding females; history of antibiotic consumption within 2 months; history of periodontal treatment within 6 months; history of hypersensitivity or treatment with statin; aggressive periodontitis; mobility grade 3; pulp pathology of teeth and poor oral hygiene. CBCT are taken and clinical parameters with probe in furca are measured. Following clinical parameters are measured at baseline and 6 months post-surgery: plaque index, bleeding index, recession, probing depth, and clinical attachment level, horizontal and vertical depth. After local anesthesia, full thickness incision with maintenance of keratinized gingiva was done. Then, reflect the flap and debridement. Measurement of horizontal and vertical bone loss is repeated and recorded. In test group, allograft bone chips combined with patient blood and simvastatin gel are put in furcation defect. Then, the defect is covered with allograft membrane. After early healing of soft tissue, surgery is done on the control side. Allograft bone chips with blood and placebo gel are put in the defect. Similar to test group, other steps of operation were done. During monthly visits, plaque and gingival index are recorded due to maintain optimal patient’s hygiene. In after 6 month visit, clinical and radiographic parameters are reevaluated and recorded.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016112631116N1
Registration date: 2017-01-07, 1395/10/18
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-01-07, 1395/10/18
Registrant information
Name
Zahra Nasiri
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3727 4820
Email address
za_nasiri@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research and Technology center, Shiraz University of Medical Sciences
Expected recruitment start date
2015-11-22, 1394/09/01
Expected recruitment end date
2016-01-21, 1394/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical evaluation of the effect of allograft alone, or in combination with simvastatin gel in the treatment of mandibular class II furcation defects in human
Public title
Effect of simvastatin gel on periodontitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1- presence at least 1 pair of first or second molar of mandible bilaterally accompanied with fraction involvement class 2 with less or equal 3 mm horizontal penetration of probe. 2- presence at least 2 mm keratinized gingiva around each tooth. Exclusion criteria: 1- smoking. 2- history of systemic disease. 3- pregnant or breast feeders. 4- history of antibiotic consumption within 2 months. 5- hx of periodontal treatment within 6 months. 6- hx of hypersensitivity to statins. 7- pt with statin treatments. 8- aggressive periodontitis. 9- tooth mobility grade 3. 10- pulp-pathology and incomplete RCT or PA lesion. 11- poor oral hygiene.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 10
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research and Technology Center
Street address
Zand Blv.
City
Shiraz
Postal code
Approval date
2015-11-01, 1394/08/10
Ethics committee reference number
IR.SUMS.REC.1394.131

Health conditions studied

1

Description of health condition studied
Furcation involvement class 2 mandible molars (periodontitis)
ICD-10 code
K05.6
ICD-10 code description
Periodontal disease, unspecified

Primary outcomes

1

Description
Clinical Attachment Level
Timepoint
preoperative, during and 6 months post surgery
Method of measurement
probe and CBCT

Secondary outcomes

1

Description
Recession
Timepoint
before Surgery- during Surgery- 6 month after
Method of measurement
Periodontal probe

2

Description
Bone Fill
Timepoint
before Surgery- during Surgery- 6 month after
Method of measurement
Periodontal probe and CBCT

3

Description
Probing pocket depth
Timepoint
before Surgery- during Surgery- 6 month after
Method of measurement
Periodontal probe and CBCT

4

Description
Horizontal penetration in the Furca
Timepoint
before Surgery- during Surgery- 6 month after
Method of measurement
Periodontal probe and CBCT

5

Description
Bleeding Index
Timepoint
before Surgery- during Surgery- 6 month after
Method of measurement
Periodontal probe

6

Description
Plaque Index
Timepoint
before Surgery- during Surgery- 6 month after
Method of measurement
Periodontal probe

Intervention groups

1

Description
Intervention group: allograft and membrane and simvastatin gel are used. After local anesthesia and incision in the target area, flap were reflected, debridemant was performed, then allograft with simvastatin gel put in the defect, membrane adapted on the defect and suture the flap
Category
Treatment - Surgery

2

Description
Control group: allograft with placebo gel. After local anesthesia and incision in the target area, flap were reflected, debridemant was performed, then allograft put in the defect, membrane adapted on the defect and suture the flap
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Perio depatment, Dentistry school,
Full name of responsible person
Dr. Farin Kiany
Street address
Shiraz Dental School
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Basir Hashemi
Street address
Zand Blv. Central Office of SUMS
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz Dentistry School
Full name of responsible person
Dr. Farin Kiany Yazdy
Position
Associate professor/ supervisor
Other areas of specialty/work
Street address
Perio department, Dentistry School, Ghasrdasht
City
Shiraz
Postal code
Phone
+98 71 3628 9919
Fax
Email
farinkiany@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz Dentistry School
Full name of responsible person
Dr. Farin Kiany Yazdy
Position
Associate professor
Other areas of specialty/work
Street address
Perio department, Dentistry School, Ghasrdasht
City
Shiraz
Postal code
Phone
+98 71 3628 9919
Fax
Email
farinkiany@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz Dentistry School
Full name of responsible person
Dr. Farin Kiany
Position
Associate professor
Other areas of specialty/work
Street address
Ghasrdasht Street- Shiraz Dental School
City
Shiraz
Postal code
Phone
Fax
Email
farinkiany@yahoo.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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