In this split-mouth randomized single-blind clinical trial, 15 moderate-to-severe chronic periodontitis patients with at least 1 pair intrabony non-adjacent lesions were entered. Pocket probing depth (PPD), clinical attachment level (CAL) and bone crest level was measured in the lesions prior to surgery. After the surgery; porous titanium granules (Natix) were implanted in the lesions at one side of the mouth and Bio-Oss + Bio-Gide membrane in the contralateral side. Clinical and radiographic parameters were again measured 4 months after the surgery and their changes were statistically analyzed by analysis of variance for repeated measures test.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015111425042N1
Registration date:2016-05-08, 1395/02/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-05-08, 1395/02/19
Registrant information
Name
Zahra Nateghi
Name of organization / entity
Shahid Beheshti
Country
Iran (Islamic Republic of)
Phone
+98 21 4433 5381
Email address
dr.nateghi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2015-12-22, 1394/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical and radiographic results of treatment of periodontal intrabony defects with porous titanium granules and xenograft with collagen membrane
Public title
Clinical and radiographic results of treatment of periodontal intrabony defects with porous titanium granules and xenograft with collagen membrane
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:no systemic disease؛ moderate to advance chronic periodontitis؛ a pair of non adjacent intrabony defects in radiograghy in alveular bone؛ good oral hygine؛ frequent dental visit
Exclusion criteria:systemic disease؛ localized or generalized aggressive periodontitis؛ suprabony defects؛ poor oral hygine؛ infrequent dental visit
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
Not 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
Department of Periodontics Shahid Beheshti Dental School
Street address
tehran
City
tehran
Postal code
Approval date
2011-02-10, 1389/11/21
Ethics committee reference number
IR.SBMU.RIDS.REC.1394.109
Health conditions studied
1
Description of health condition studied
moderate to severe chronic periodontitis
ICD-10 code
B99
ICD-10 code description
B99
Primary outcomes
1
Description
clinical attachment level measurment from CEJ to sulcular depth
Timepoint
Before intervention ,4 month after intervention
Method of measurement
Periodontal probe
2
Description
pocket probing depth measurement from gingival margin to sulcular depth
Timepoint
Before intervention ,4 month after intervention
Method of measurement
Periodontal probe
Secondary outcomes
1
Description
Quality of alveolar bone
Timepoint
Before intervention , 4 months after intervention
Method of measurement
Radiografic assesment
Intervention groups
1
Description
Intervention group 1 :Porous Titanium Granules which is made in swiss without membrane used for treatment of intrabony defects
Category
Treatment - Surgery
2
Description
Control group :Bio-Oss which is bovine xenograft with Bio-Gide which is porcine collagene membrane are used for treatment of intrabony defects
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Deparment of Periodontics
Full name of responsible person
zahra nateghi
Street address
tehran
City
tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
vice chancellor for Research of Dental School ,Shahid Beheshti University of Medical Science
Full name of responsible person
dr arash khojasteh
Street address
tehran
City
tehran
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 Dental School ,Shahid Beheshti University of Medical Science
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
Dental School, Shahid Beheshti University of Medical Sciences
Full name of responsible person
zahra nateghi
Position
resident
Other areas of specialty/work
Street address
tehran
City
tehran
Postal code
Phone
+93 86570605
Fax
Email
minanateghi44@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Periodontics ,School of Dentistry , Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Nateghi
Position
post graduate student
Other areas of specialty/work
Street address
tehran
City
tehran
Postal code
Phone
+98 44335381
Fax
Email
minanateghi44@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Periodontics, Dental School, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Nateghi
Position
post graduate student
Other areas of specialty/work
Street address
Tehran
City
Tehran
Postal code
00
Phone
00
Fax
Minanateghi44@yahoo.com
Email
minanateghi44@yahoo.com
Web page address
Minanateghi44@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)