Protocol summary

Study aim
Determination of gingiva biotype and buccal bone thickness and supracrestal tissue thickness with dimensional changes of ridge following of tooth extraction.
Design
In this study, 30 patients who needed to extract the anterior teeth of maxilla have participated in the procedure. Before extracting the tooth, the gingiva biotype and supracrestal tissue thickness and buccal bone thickness at 1, 3 and 5 mm points of the bone crest and the size of the ridge dimensions at points 1 and 3 And 5 mm of bone crest was determined. Then the teeth were extracted and after 3 months the size of the ridge dimensions at 1, 3 and 5 mm points of bone crest was re-examined.
Settings and conduct
This research was conducted at the Tehran Dental University and 30 patients who needed to extract the anterior teeth of maxilla participated. Before extract the tooth, the gingival biotype with Colorvue biotype probe and supracrestal tissue thickness and buccal bone thickness at intervals of 1, 3 and 5 mm from the bone crest and the size of the ridge dimensions at 1, 3 and 5 mm intervals were determined by 3D radiography and then the teeth were extracted. After 3 months, the size of the ridge dimensions at 1, 3, and 5 mm intervals from the bone crest was measured by 3D radiography checked again.
Participants/Inclusion and exclusion criteria
Entry requirements:The person who need extraction anterior teeth of maxilla. Conditions of non-arrival: Those with a horizontal gingival analysis of more than 60%. People with dental infection. People who use antibiotics. People with Systemic Disease. People who take medications that increase gum volume. People with a pocket depth of at least 4 mm. People with a history of gum surgery. People who smoke.
Intervention groups
In all subjects, the tooth extraction procedure is performed.
Main outcome variables
Gingival biotypes and thickness of supracrestal tissue and buccal bone thickness at 1, 3 and 5 mm intervals of bone crest and ridge dimensions at intervals of 1, 3 and 5 mm from bone crest after 3 months

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170419033535N3
Registration date: 2018-02-11, 1396/11/22
Registration timing: registered_while_recruiting

Last update: 2018-02-11, 1396/11/22
Update count: 0
Registration date
2018-02-11, 1396/11/22
Registrant information
Name
omid moghaddas
Name of organization / entity
islamic azad unicersity dental of teh
Country
Iran (Islamic Republic of)
Phone
+98 912 277 6280
Email address
o_moghaddas@dentaliau.ac.ir
Recruitment status
Recruitment complete
Funding source
have private source
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Review of gingiva biotype and buccal bone thickness and supracrestal tissue thickness with dimensional changes of ridge following of tooth extraction
Public title
Review of gingiva biotype and buccal bone thickness and supracrestal tissue thickness with dimensional changes of ridge following of tooth extraction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The person who need extraction anterior teeth of maxilla
Exclusion criteria:
The person that have horizintal atrophy more than 60%. The person that have teeth infection. The person that need to use antibiotics. The person that have systemic diseases. The person use any drugs that cause increase volume of gingiva. The person that have pocket depth minimum 4 mm. The person who had gingiva surgry. The person that smoke.
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Islamic Azad University of Dental of Tehran
Street address
Neyestan 9 Street, Pasdaran Ave, Tehran Town
City
Tehran
Province
Tehran
Postal code
19585175
Approval date
2017-03-12, 1395/12/22
Ethics committee reference number
IR.IAU.DENTAL.REC.1395.31

Health conditions studied

1

Description of health condition studied
changes in ridge dimensions after tooth extraction
ICD-10 code
K08.2
ICD-10 code description
Atrophy of edentulous alveolar ridge

Primary outcomes

1

Description
gingiva biotype
Timepoint
3 months
Method of measurement
Colorvue biotype probe

2

Description
buccal bone thickness
Timepoint
3 months
Method of measurement
Cone Beam CT(CBCT)

3

Description
supracrestal thickness
Timepoint
3 months
Method of measurement
sounding method

Secondary outcomes

1

Description
dimensional changes of ridge
Timepoint
3 months
Method of measurement
Cone Beam CT (CBCT)

Intervention groups

1

Description
the extraction of teeth
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Islamic Azad University Dental of Tehran
Full name of responsible person
Omid Moghaddas
Street address
Neyestan 9 Street , Pasdaran Ave, Tehran Town
City
Tehran
Province
Tehran
Postal code
19585175
Phone
+98 21 2221 2517
Email
noruzifaranak9@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Arash Azizi
Street address
Neyestan 9 Street , Pasdaran Avenue , Tehran Town
City
Tehran
Province
Tehran
Postal code
19585175
Phone
+98 21 2256 4572
Email
noruzifaranak9@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University of Dental of Tehran
Full name of responsible person
Omid Moghaddas
Position
Assistant periodontist
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Neyestan 9 Street, Pasdaran Avenue, Tehran Town
City
Tehran
Province
Tehran
Postal code
19585175
Phone
+98 21 2256 4572
Fax
Email
O_moghaddas@dentaliau.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University of Dental of Tehran
Full name of responsible person
Omid Moghaddas
Position
Assistand periodontist
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Neyestan 9 Street , Pasdaran Avenue , Tehran Town
City
Tehran
Province
Tehran
Postal code
19585175
Phone
+98 21 2256 4572
Fax
Email
O_moghaddas@dentaliau.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University of Dental of Tehran
Full name of responsible person
Zahra Noruzian Fard
Position
Dentistry student
Latest degree
Medical doctor
Other areas of specialty/work
Street address
Neyestan 9 Street , Pasdaran Ave, Tehran Town
City
Tehran
Province
Tehran
Postal code
19585175
Phone
+98 21 2221 2517
Fax
Email
Noruzifaranak9@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Review of gingiva biotype and buccal bone thickness and supracrestal tissue thickness with dimensional changes of ridge following of tooth extraction in Referring to Islamic Azad University, Dental Branch of Tehran in 1395-1396
When the data will become available and for how long
Start the access period 6 months after printing the results.
To whom data/document is available
All people who need data can take action to get them.
Under which criteria data/document could be used
Analyzes that do not damage the outcome of our data analysis are allowed.
From where data/document is obtainable
Visit the Islamic Azad University of Dentistry in Tehran.
What processes are involved for a request to access data/document
Visit the Islamic Azad University of Tehran Branch and apply for it and access the data for up to 1 week.
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