Protocol summary

Summary
This study will be done with aim to investigate the effectiveness of leggy rotating flap on the periodontal condition of second mandibular molar after molar surgery. This is triple-blind clinical trial. The study population will be included patients referred to a personal dentist's office. 15 patients with 2-way the mandibular third molars teeth will be selected in available method and randomly divided into control and experimental groups that a control group will be on the side and experimental group will be on the other side. In the experimental group after the withdrawal of tooth and second molar tooth SRP a leggy rotating flap prepared form the third molars sticky gum is placed in contact the second molar distal surface.In control group an envelope flap with the release of third molars distal to the Ramos from the third molar to first molar is used, when closing the flap of operculum edge wound is caused and dental cavities takes full coverage and restoration will occur in primary. All measurement criteria are applied before surgery and the attached gingiva and probing depth is measured after two months of calling meetings. Other measurement criteria are measured in the first week after surgery. Inclusion criteria: Age between 20 -30; Patients with bilateral mandibular third molars includes class A in Pell and Gregory classification. Exclusion criteria: Patient's unwillingness to cooperate

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017021014333N66
Registration date: 2017-03-03, 1395/12/13
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-03-03, 1395/12/13
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kermanshah University of Medical Sciences
Expected recruitment start date
2017-02-23, 1395/12/05
Expected recruitment end date
2017-04-25, 1396/02/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effectiveness and non-effectiveness of leggy rotating flap on the periodontal condition of second mandibular molar after molar surgery
Public title
Periodontal evaluation of rotational pedicle flap used in extraction of third molar
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age between 20 -30; Patients with bilateral mandibular third molars includes class A in Pell and Gregory classification. Exclusion criteria: Patient's unwillingness to cooperate
Age
From 20 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 15
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Approval date
2016-12-28, 1395/10/08
Ethics committee reference number
kums.rec.1395.563

Health conditions studied

1

Description of health condition studied
Impacted teeth
ICD-10 code
K01
ICD-10 code description
embedded and impacted teeth with abnormal position of such teeth or adjacent teeth

Primary outcomes

1

Description
The attached gingiva
Timepoint
Baseline, two months after surgery
Method of measurement
By periodontal probe

2

Description
Depth of probe
Timepoint
Baseline, two months after surgery
Method of measurement
By periodontal probe

Secondary outcomes

empty

Intervention groups

1

Description
In the experimental group after the withdrawal of tooth and second molar tooth SRP a leggy rotating flap prepared form the third molars sticky gum is placed in contact the second molar distal surface
Category
Treatment - Surgery

2

Description
In control group an envelope flap with the release of third molars distal to the Ramos from the third molar to first molar is used, when closing the flap of operculum edge wound is caused and dental cavities takes full coverage and restoration will occur in primary
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Personal office
Full name of responsible person
Amin Kananizadeh
Street address
street of Dabir Azam, Department Kosar
City
Kermanshah

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Koroush Hamzehee
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
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, Kermanshah University of Medical Sciences
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
Kermanshah University of Medical Sciences
Full name of responsible person
Amin Kananizadeh
Position
Student of dentistry
Other areas of specialty/work
Street address
School of dentistry, Shariati Street
City
Kermanshah
Postal code
Phone
+98 83 3721 8209
Fax
Email
amin.kanani@yahoo.com‏
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Hesamedin Nazari
Position
Specialist Oral and Maxillofacial Surgery
Other areas of specialty/work
Street address
School of dentistry, Shariati Street
City
Kermanshah
Postal code
Phone
+98 83337222400
Fax
Email
Hesamedin_nazari@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Amin Kananizadeh
Position
Student of dentistry
Other areas of specialty/work
Street address
Student of dentistry
City
Kermanshah
Postal code
Phone
+98 83 3721 8209
Fax
Email
amin.kanani@yahoo.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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