Protocol summary

Summary
Aims: The aim of this study is to clinically evaluate the efficacy of ABBM and GTR by the means of connective tissue as a membrane (CTG)with and without PRP in treatment of intrabony defects. Materials and methods : In this double-blind randomized clinical trial 15 pair of intrabony defects in 15 patients with chronic periodontal disease were randomly treated with a combination of either PRP+ABBM+CTG or ABBM+CTG. The following clinical parameters were evaluated at baseline and at 6 months Re-entry with using a stent as reference point: probing pocket depth (PPD), clinical attachment level (PAL-S), free gingival margin position (FGM-S), crestal position(CREST-S),Crest to defect depth and defect depth to stent.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201104116167N1
Registration date: 2011-10-27, 1390/08/05
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-10-27, 1390/08/05
Registrant information
Name
Omid Moghaddas
Name of organization / entity
Islamic Azad University of Isfahan(Khorasgan)
Country
Iran (Islamic Republic of)
Phone
+98 31 1535 4053
Email address
o.moghaddas@khuisf.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2010-03-11, 1388/12/20
Expected recruitment end date
2011-03-06, 1389/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of connective tissue graft as a membrane and ABBM With and without PRP in treatment of intrabony defects
Public title
Efficacy of connective tissue graft as a membrane and ABBM With and without PRP in treatment of intrabony defects
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: No amount of 25% or less plaque before surgery . Teeth with a mobility of less than 3 Miller . Endodontic treatment of teeth or vital teeth. . Patients with moderate to advanced chronic periodontitis and at least one pair of radiographic lesions in non-adjacent teeth, and vertically between the minimum level of attachment to the CEJ from the first phase of treatment is 5 mm. The depth of the defect during surgery is at least 3 mm. The vertical wall is 2 or 3 bone lesions. Exclusion criteria: 1. Systemic diseases 2. Pregnancy and breast feeding 3. The systemic use of antibiotics in the past three months 4. Abnormal platelet count before surgery in a month 5. Furcation involvement and grade 3 or 4 6. Other forms of chronic periodontitis periodontitis to 7. History of periodontal surgery in 6 Months
Age
From 20 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
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
Islamic Azad University, Dental Faculty, Khorasgan, Isfahan
Street address
Islamic Azad University, Dental Faculty, Khorasgan, Isfahan
City
Isfahan
Postal code
Approval date
2010-01-16, 1388/10/26
Ethics committee reference number
23810201892022

Health conditions studied

1

Description of health condition studied
Alveolar vertical bony defects
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Pocket depth
Timepoint
Before and 6 months after
Method of measurement
Probe and Acrylic stent

2

Description
Clinical attachment level
Timepoint
Before and 6 months after
Method of measurement
Probe and Acrylic stent

3

Description
Free ginigival margin position
Timepoint
Before and 6 months after
Method of measurement
Probe and Acrylic stent

4

Description
Alveolar crest position
Timepoint
During and 6 months after
Method of measurement
Probe and Acrylic stent

5

Description
Defect depth to Stent
Timepoint
Before and 6 months after
Method of measurement
Probe and Acrylic stent

Secondary outcomes

empty

Intervention groups

1

Description
Connective Tissue as a Membrane And ABBM(anorganic bovine bone ) With PRP .
Category
Treatment - Surgery

2

Description
Connective Tissue as a Membrane And ABBM(anorganic bovine bone ) Without PRP .
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Dental Faculty,Islamic Azad University,Khorasgan Isfahan
Full name of responsible person
Street address
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Dental Faculty,Islamic Azad University,Khorasgan ,Isfahan
Full name of responsible person
Vahid Esfahanian
Street address
Dental Faculty,Islamic Azad University,Khorasgan ,Isfahan
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dental Faculty,Islamic Azad University,Khorasgan ,Isfahan
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 Faculty,Islamic Azad University,Khorasgan ,Isfahan
Full name of responsible person
Omid Moghaddas
Position
Periodontist
Other areas of specialty/work
Street address
Dental Faculty,Islamic Azad University,Khorasgan ,Isfahan
City
Isfahan
Postal code
Phone
+98 31 1535 4066
Fax
Email
hmonn555@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Dental Faculty,Islamic Azad University,Khorasgan ,Isfahan
Full name of responsible person
Omid Moghaddas
Position
Periodontist
Other areas of specialty/work
Street address
Dental Faculty,Islamic Azad University,Khorasgan ,Isfahan
City
Isfahan
Postal code
Phone
+98 31 1535 4054
Fax
Email
hmonn555@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Omid Moghaddas
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
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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