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 Nanobone 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 defect will be measured and half of the defects (25 defects) will be filled with Nanobone and the other half will be filled by Bio-Oss. Six months later a re-entry surgery will be done and the same parameters will be measured.The secondary outcomes are the differences between pocket depth, clinical attachment level, plaque index, bleeding on probing at the baseline and six months after the first surgery. This is a single blind (patients) study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016022624622N2
Registration date:2016-04-25, 1395/02/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-04-25, 1395/02/06
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
2016-03-31, 1395/01/12
Expected recruitment end date
2017-01-31, 1395/11/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative effect of Nanobone and Bio-Oss on bone regeneration in periodontal defects: A randomized clinical trial
Public title
The effect of a new bone material in the treatment of bony defects caused by periodontal disease: A randomized clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion 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:
100
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
2010-08-20, 1389/05/29
Ethics committee reference number
IR.UMSHA.REC.1394.468
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 day
Method of measurement
Using a periodontal probe
2
Description
Keratinized tissue
Timepoint
At the first surgery day
Method of measurement
Using a periodontal probe
3
Description
Bleeding on probing
Timepoint
At the first surgery day
Method of measurement
Using a periodontal probe
4
Description
Clinical attachment level
Timepoint
At the first surgery day
Method of measurement
Using a periodontal probe
5
Description
Gingival recession
Timepoint
At the first surgery day
Method of measurement
Using a periodontal probe
6
Description
Plaque index
Timepoint
At the first surgery day
Method of measurement
Disclosing agents
7
Description
Width of the defect
Timepoint
At the first surgery day
Method of measurement
Using a periodontal probe
8
Description
Pocket depth
Timepoint
At the first surgery day
Method of measurement
Using a periodontal probe
Secondary outcomes
1
Description
Bleeding on probing
Timepoint
6 months after first surgery
Method of measurement
Using a periodontal probe
2
Description
Gingival recession
Timepoint
6 months after first surgery
Method of measurement
Using a periodontal probe
3
Description
Clinical attachment level
Timepoint
6 months after first surgery
Method of measurement
Using a periodontal probe
4
Description
Depth of the defect
Timepoint
6 months after first surgery
Method of measurement
Using a periodontal probe
5
Description
Pocket depth
Timepoint
6 months after first surgery
Method of measurement
Using a periodontal probe
6
Description
Keratinized tissue
Timepoint
6 months after first surgery
Method of measurement
Using a periodontal probe
7
Description
Width of the defect
Timepoint
6 months after first surgery
Method of measurement
Using a periodontal probe
8
Description
Plaque index
Timepoint
6 months after first surgery
Method of measurement
using disclosing agent
Intervention groups
1
Description
Treatment using Bio-Oss in the control group. Surgery is done using a full thickness flap with an extension of one tooth at each side of the defect. After flap reflection a complete debridement of the defect would be done and the defect would be filled by bone substitutes.
Category
Other
2
Description
Treatment using Nanobone in the test group. Surgery is done using a full thickness with extension of one tooth at each side of the defect. After flap reflection a complete debridement of the defect would be done and the defect would be filled by bone substitutes.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamedan University of Medical Sciences
Full name of responsible person
vahid Raziani
Street address
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vahid Raziani
Full name of responsible person
Vahid Raziani
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
Vahid Raziani
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
Vahid Raziani
Position
Assistant 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
+98 81 3824 7464
Fax
Email
vahidraziani@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Vahid Raziani
Position
Assistant 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
+98 81 3824 7464
Fax
Email
vahidraziani@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Vahid Raziani
Position
Assistant 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
+98 81 3824 7464
Fax
Email
vahidraziani@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)