Reconstruction of bony defects caused by periodontal disease is a major issue of periodontal treatments. Bone substitutes have long been used in reconstructive surgery in a previous defect area.The aim of this study is to evaluate the comparative effect of Bio-Oss and PTG (Porous Titanium Granules) on bone regeneration in periodontal vertical defects.patients with vertical defects are selected for this study.at the first surgery parameters such as the height and the width of the defectwill be measured and half of the defects (25 defects) will be filled with PTG and the other half will be filled by Bio-Oss.Six months later a re-entry surgery will be done and the same baseline parameters will be measured.The secondary outcomes are the differences between pocket depth, clinical attachment level, plague index, bleeding on broping at the baseline and six months after the first surgery.This is a single blind(patients) study.
General information
Acronym
Porous Titanium Granules (PTG)
IRCT registration information
IRCT registration number:IRCT2015102024622N1
Registration date:2015-11-22, 1394/09/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-11-22, 1394/09/01
Registrant information
Name
Samareh Kafilzadeh
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8835 9991
Email address
s.kafilzadeh@edu.umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamedan University of Medical Sciences
Expected recruitment start date
2015-11-21, 1394/08/30
Expected recruitment end date
2016-04-19, 1395/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative effect of Porous Titanium Granules and Bio-Oss on bone regeneration in periodontal defects
Public title
The effect of a new bone material in the treatment of bony defects caused by periodontal disease
Purpose
Treatment
Inclusion/Exclusion criteria
Patients with at least one vertical defect assessed by clinical and radiographic evaluation
Patients with no systemic disease
Age
No age limit
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)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Hamedan University of Medical Sciences
Street address
Hamedan- University of Medical Sciences
City
Hamedan
Postal code
Approval date
2015-08-15, 1394/05/24
Ethics committee reference number
IR.UMSHA.REC.1394.271
Health conditions studied
1
Description of health condition studied
Chronic periodontitis
ICD-10 code
KO5.3
ICD-10 code description
Chronic Periodontits
Primary outcomes
1
Description
depth of the defect
Timepoint
at the first surgery and 6 months later at a re-entry surgery
Method of measurement
using a periodontal probe
2
Description
width of the defect
Timepoint
at the first surgery and 6 months later at a re-entry surgery
Method of measurement
using a periodontal probe
Secondary outcomes
1
Description
keratinized tissue
Timepoint
at the first surgery and 6 months later at a re-entry surgery
Method of measurement
using a periodontal probe
2
Description
plaque index
Timepoint
at the first surgery and 6 months later at a re-entry surgery
Method of measurement
using a periodontal probe
3
Description
gingival recession
Timepoint
at the first surgery and 6 months later at a re-entry surgery
Method of measurement
using a periodontal probe
4
Description
bleeding on probing
Timepoint
at the first surgery and 6 months later at a re-entry surgery
Method of measurement
using a periodontal probe
5
Description
clinical attachment level
Timepoint
at the first surgery and 6 months later at a re-entry surgery
Method of measurement
using a periodontal probe
6
Description
pocket depth
Timepoint
at the first surgery and 6 months later at a re-entry surgery
Method of measurement
using a periodontal probe
Intervention groups
1
Description
treatment using porous titanium granules (PTG) in the test group.
surgery is done using a full thickness with a distance of one tooth at each side of the defect. after flap reflection a complete debrement of the defect would be done.and the defect would be filled by bone substitutes.
Category
Treatment - Other
2
Description
treatment using Bio-Oss in the control group. surgery is done using a full thickness with a distance of one tooth at each side of the defect. after flap reflection a complete debrement of the defect would be done.and the defect would be filled by bone substitutes.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamedan University of Medical Sciences
Full name of responsible person
Samareh Kafilzadeh
Street address
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Samareh Kafilzadeh
Full name of responsible person
Samareh Kafilzadeh
Street address
Department of Periodontology, Faculty of Dentistry, Hamedan University of Medical Sciences, Hamedan
City
hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Samareh Kafilzadeh
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
Hamedan University of Medical Sciences
Full name of responsible person
Samareh Kafilzadeh
Position
Resident
Other areas of specialty/work
Street address
Department of Periodontology, Faculty of Dentistry, Hamedan University of Medical Sciences, Hamedan
City
Hamedan
Postal code
Phone
+81 8247464
Fax
Email
sn4014@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Samareh Kafilzadeh
Position
Resident
Other areas of specialty/work
Street address
Department of Periodontology, Faculty of Dentistry, Hamedan University of Medical Sciences, Hamedan
City
Hamedan
Postal code
Phone
+81 38247464
Fax
Email
sn4014@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Samareh Kafilzadeh
Position
Resident of Periodontics
Other areas of specialty/work
Street address
Department of Periodontology, Faculty of Dentistry, Hamedan University of Medical Sciences, Hamedan
City
Hamedan
Postal code
Phone
+81 38247464
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)