Protocol summary

Summary
Aims: Usage of palatal connective tissue graft with and without periosteum along with Bio-Oss in treatment of vertical alveolar bone defects. Study design: Randomized; Interventional; Double blind; No Placebo usage; Uni-center; Crossover. a- Study population: With age limit; no sex limit. Inclusion Criteria: Plaque Index 25% or less before surgery; teeth with mobility of Miller grade III or less; Vital teeth or nonvital teeth with proper endodontic treatment; patients with moderate to severe chronic periodontitis; radiologic approval of a pair of interdental vertical bone defects in two non-adjacent teeth; Clinical attachment loss more than 5millimeteres; defect depth must be at least 3millimeters; intrabony two or three walls defects. Exclusion Criteria: Patients with any systemic disorders; pregnant and breast feeder patients; Systemic antibiotic usage in the last three months; abnormal platelet count in the last month before surgery; Grade III of Furcation involvement; History of periodontal surgery in the last six months. Sample size:15 patients; 30 sites. b- Intervention/Control: Intervention: Palatal connective Tissue graft with periosteum as a membrane With Bio-oss. Control: Palatal connective Tissue graft without periosteum as a membrane With Bio-oss. Time of intervention: 6 months. Primary or under study outcome measures: Probing Pocket Depth; Clinical Attachment Level; Defect fill; Gingival margin status; Crestal bone status; amount of defect resolve.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012101611133N1
Registration date: 2013-01-31, 1391/11/12
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-01-31, 1391/11/12
Registrant information
Name
Mohamadreza Ghafari
Name of organization / entity
Islamic Azad Dental School Khorasgan Branch, (Isfahan), Iran
Country
Iran (Islamic Republic of)
Phone
+98 31 1535 4053
Email address
mr.ghafari@khuisf.ac.ir
Recruitment status
Recruitment complete
Funding source
Private
Expected recruitment start date
2012-04-03, 1391/01/15
Expected recruitment end date
2012-10-06, 1391/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of palatal connective tissue graft usage with and without periosteum as a membrane along with Bio-Oss in treatment of vertical alveolar bone defects
Public title
Usage of palatal connective tissue graft in treatment of vertical alveolar bone defects
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Plaque Index 25% or less before surgery; teeth with mobility of Miller grade III or less; Vital teeth or nonvital teeth with proper enbdodntic treatment; patients with moderate to severe chronic periodontitis; radiologic approval of a pair of interdental vertical bone defects in two non-adjacent teeth; Clinical attachment loss more than 5millimeteres; defect depth must be at least 3millimeters; intrabony two or three walls defects. Exclusion Criteria: Patients with any systemic disorders; pregnant and breast feeder patients; Systemic antibiotic usage in the last three months; abnormal platelet count in the last month before surgery; Grade III of Furcation involvement; History of periodontal surgery in the last six 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
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Islamic Azad Dental School Khorasgan Branch, (Isfahan), Iran
Street address
Islamic Azad University Khorasgan (Isfahan) Branch, University Boulevard, Arghavanieh, Eastern Jay Street, Isfahan, Iran. Isfahan Isfahan Iran, Islamic Republic Of
City
Isfahan
Postal code
Approval date
2012-05-26, 1391/03/06
Ethics committee reference number
91030609501

Health conditions studied

1

Description of health condition studied
Chronic Periodontitis
ICD-10 code
K05.3
ICD-10 code description
Chronic periodontitis

Primary outcomes

1

Description
Probing Pocket depth
Timepoint
0 and 6 months
Method of measurement
per millimiters by means of a UNC-15 Periodnotal Probe

2

Description
Clinical Attachment Level
Timepoint
0 and 6 months
Method of measurement
per millimiters by means of a UNC-15 Periodnotal Probe

3

Description
Gingival margin status
Timepoint
0 and 6 months
Method of measurement
per millimiters by means of a UNC-15 Periodnotal Probe

4

Description
Defect Bone Fill
Timepoint
0 and 6 months
Method of measurement
per millimiters by means of a UNC-15 Periodnotal Probe

5

Description
Crestal Bone Status
Timepoint
0 and 6 months
Method of measurement
per millimiters by means of a UNC-15 Periodnotal Probe

6

Description
amount of defect resolve
Timepoint
0 and 6 months
Method of measurement
per millimiters by means of a UNC-15 Periodnotal Probe

Secondary outcomes

empty

Intervention groups

1

Description
Palatal connective Tissue graft with periosteum as a membrane
Category
Treatment - Surgery

2

Description
Palatal connective Tissue graft without periosteum as a membrane
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Islamic Azad Dental School Khorasgan Branch, (Isfahan), Iran
Full name of responsible person
Mohamadreza Ghafari
Street address
Islamic Azad University Khorasgan (Isfahan) Branch, University Boulevard, Arghavanieh, Eastern Jay Street, Isfahan, Iran.
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad Dental School Khorasgan Branch, (Isfahan), Iran
Full name of responsible person
Vahid Esfahanian
Street address
Islamic Azad University Khorasgan (Isfahan) Branch, University Boulevard, Arghavanieh, Eastern Jay Street, Isfahan, Iran
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad Dental School Khorasgan Branch, (Isfahan), Iran
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
Islamic Azad Dental School Khorasgan Branch, (Isfahan), Iran
Full name of responsible person
Mohamadreza Ghafari
Position
Popst-graduate Student of Periodontics
Other areas of specialty/work
Street address
Islamic Azad University Khorasgan (Isfahan) Branch, University Boulevard, Arghavanieh, Eastern Jay Street, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 1535 4001
Fax
Email
shahabgh1982@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad Dental School Khorasgan Branch, (Isfahan), Iran
Full name of responsible person
Mohamadreza Ghafari
Position
Post_graduated Student Of Periodontics
Other areas of specialty/work
Street address
Islamic Azad University Khorasgan (Isfahan) Branch, University Boulevard, Arghavanieh, Eastern Jay Street, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 1535 4001
Fax
Email
shahabgh1982@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad Dental School Khorasgan Branch, (Isfahan), Iran
Full name of responsible person
Mohamadreza Ghafari
Position
Post-Graduated Student Of Periodontics
Other areas of specialty/work
Street address
Islamic Azad University Khorasgan (Isfahan) Branch, University Boulevard, Arghavanieh, Eastern Jay Street, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 1535 4001
Fax
Email
shahabgh1982@gmail.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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