The purpose of this study is to compare the effect of Cenobone with Matchstick in preserving the alveolar ridge and soft tissue after tooth extraction, which has not been studied in this regard so far.
Design
Patients will be double-blind and divided into 3 groups. The first group consists of 13 people who are filled with Cenobone in silence. The second group consists of 13 people who we put inside the Matchstick tooth silencer. The third group also includes 13 people, considered the control group, and we put it inside the Collacone silence alone. The study will be conducted in a double-blind manner and each patient will be randomly assigned to one of the groups using sealed envelopes.
Settings and conduct
Department of Periodontology, Jundi Shapur Faculty of Dentistry, Ahvaz
Participants/Inclusion and exclusion criteria
Entry requirements:
The tooth is unmaintainable and a candidate for extraction
Age group 18 to 60 years
non-smoker
The thickness of the buccal wall should be less than 2 mm.
All silent walls are healthy
Systemically healthy
not pregnant
Non-entry conditions:
The tooth has a periapical lesion
Taking drugs that affect bone metabolism, such as bisphosphonates
Have uncontrolled diabetes or high blood pressure
The buccal wall should have a sensation or perforation
Intervention groups
The first group consists of 13 people who are filled with Cenobone in silence. The second group consists of 13 people who we put inside the Matchstick tooth silencer. The third group also includes 13 people, which is considered as the control group, and we put it inside the Collacone silence alone.
Main outcome variables
Ridge restoration material No. 1 (cenobone)
Ridge restoration material No. 2 (matchstick)
The alveolar ridge buccolingual dimension from a clinical point of view
Clinical ridge height
Soft tissue dimensions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221124056599N1
Registration date:2023-04-18, 1402/01/29
Registration timing:retrospective
Last update:2023-04-18, 1402/01/29
Update count:0
Registration date
2023-04-18, 1402/01/29
Registrant information
Name
Farzane Mehranfar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3391 3660
Email address
farzane.mehranfar85@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-20, 1401/10/30
Expected recruitment end date
2023-03-21, 1402/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Cenobone biomaterials with Matchstick on the preservation of alveolar ridge and soft tissue after tooth extraction
Public title
Comparison of Cenobone biomaterials with Matchstick on the preservation of alveolar ridge and soft tissue after tooth extraction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The tooth is unmaintainable and a candidate for extraction (due to severe caries, root fracture, failure of root treatment)
Age group 18 to 60 years
non-smoker
The thickness of the buccal wall should be less than 2 mm.
All walls are healthy
Systemically healthy.
Exclusion criteria:
The tooth has a peri apical lesion.
Taking drugs that affect bone metabolism like bisphosphonates
have a uncontrolled diabetes or high blood pressure
the buccal wall have a fenestration or dehiscence
pregnancy
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
39
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomize from the design of random blocks of three that become six states, we randomly select a block of three from one to six, and according to the sample size, thirteen blocks are selected and selected based on the material desired by each person.
Blinding (investigator's opinion)
Double blinded
Blinding description
39 of the same color and size envelopes are prepared and a code is written inside each envelope that belongs to one of the groups and one of the envelopes is randomly selected for each patient. A way that only the surgeon will be aware of the type of substance consumed for each group, and the participants, those responsible for data collection, and the person who evaluates the outcome are not aware of the type of substance consumed.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Jundishapur University of Medical Sciences, Ahvaz
Street address
Kian Abad, West 19th St., No. 88
City
ahvaz
Province
Khouzestan
Postal code
6155749845
Approval date
2022-11-15, 1401/08/24
Ethics committee reference number
IR.AJUMS.REC.1401.345
Health conditions studied
1
Description of health condition studied
Measurement of alveolar ridge buccolingual dimension from a clinical point of view Measurement of the clinical height of the ridge Measurement of soft tissue dimensions
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Reduction of bone and soft tissue resorption
Timepoint
4months later
Method of measurement
Before tooth extraction, an alginate mold will be taken and a diagnostic cast will be prepared. A template (stent) will be made on the occlusal surface of the candidate tooth and at least one more anterior and posterior tooth on the study cast with self-curing acrylic. This stent allows the measurement of alveolar ridge bone to be repeated at two different times, one immediately after tooth extraction and the other 4 months after keeping silent. Alveolar crest height is measured with a periodontal probe from inside the stent to the middle part of the buccal crest wall. We create an indentation in the stent to guide the same position and angle of entry of the probe when it is used a second time. The buccolingual ridge width is also measured by the periodontal probe from midbuccal/midlabial to midlingual/midpalatal.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The first intervention group: Ridge restoration material No. 1 (cenobone), the second intervention group: Ridge restoration material No. 2 (matchstic)
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
In the periodontology and surgery department of Jundishapur Dental School, Ahvaz
Full name of responsible person
Farzaneh Mehranfar
Street address
Golestan, Jundishapur Ahvaz University, Department of Surgery and Periodontology
City
Ahvaz
Province
Khouzestan
Postal code
0
Phone
+98 61 3333 3333
Email
farzane.mehranfar85@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ali Ahmadi
Street address
Golestan, Jundishapur Ahvaz University, Department of Surgery and Periodontology
City
Ahvaz
Province
Khouzestan
Postal code
0
Phone
+98 61 3333 3333
Email
farzane.mehranfar85@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
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
Ahvaz University of Medical Sciences
Full name of responsible person
Farzaneh Mehranfar
Position
Periodontics Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No. 152, Phase III, West 5th Street, Kianpars
City
Ahvaz
Province
Khouzestan
Postal code
0
Phone
+98 61 3391 3660
Email
farzane.mehranfar85@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Farzaneh Mehranfar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No. 152, Phase III, West 5th Street, Kianpars
City
Ahvaz
Province
Khouzestan
Postal code
6155835187
Phone
+98 61 3391 3660
Email
farzane.mehranfar85@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Farzaneh Mehranfar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No. 152, Phase III, West 5th Street, Kianpars
City
Ahvaz
Province
Khouzestan
Postal code
6155835187
Phone
+98 61 3391 3660
Email
farzane.mehranfar85@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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