Comparison of the effect of specific abutments on maintaining alveolar ridge contour in immediate posterior implants
Design
The clinical trial has a control group with two parallel groups, a blind strain, randomly classified in blocks of 4 on 26 patients.
Settings and conduct
Eligible people are selected from the patients of Tehran Azad Dental School. Before surgery, a complete jaw mold is prepared. The tooth is extracted and the implant is placed. the control group: Conventional Healing Abutment is placed, the other group: Customized Healing Abutment is placed in the form given by the composite that formed. Recall session 6 months after the surgery, molding is done and a plaster cast is cast. A gauge is used to measure the width of the ridge. a parallel radiograph is prepared on the day of surgery and a radiograph 6 months after surgery. The amount of bleeding on probing and probing pocket depth is evaluated after 6 months.
Participants/Inclusion and exclusion criteria
Inclusion criteria: presence of hopeless molar teeth
No periodontal disease and decay
Complete oral plaque score and bleeding below 20%
Agreeing with research condition
Exclusion criteria:Systemic or psychological conditions that are contraindications for implant placement
Absence of a healthy bone wall in a tooth socket following tooth extraction
Patient non-cooperation
Heavy smoker (more than 10 cigarettes per day)
Bruxism or other disruptive parafunctional habits
Primary Stability below 20
Intervention groups
Intervention group: It is formed with composite around the abutment based on the silent shape.
Control group: the abutment without composite is placed in the usual way.
Main outcome variables
Alveolar ridge width
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180714040460N10
Registration date:2024-01-17, 1402/10/27
Registration timing:registered_while_recruiting
Last update:2024-01-17, 1402/10/27
Update count:0
Registration date
2024-01-17, 1402/10/27
Registrant information
Name
Nima Nadafpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2256 4571
Email address
n_nadaf@dentaliau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-22, 1402/10/01
Expected recruitment end date
2024-02-20, 1402/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of dedicated healing abutments on clinical and radiographic factors of immediate implants in molar areas after six months
Public title
Investigating the effect of customized healing piece on alveolar ridge contour
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The presence of hopeless molar teeth in the mandible or maxilla
No periodontal disease and obvious decay
Complete oral plaque score and bleeding below 20%
Agreeing to the conditions of the research and signing the consent form
Exclusion criteria:
Systemic or psychological conditions that are contraindications for implant placement
Absence of a healthy bone wall in a tooth socket following tooth extraction
Patient non-cooperation
heavy smoker
Bruxism or other disruptive parafunctional habits
Primary Stability under 20
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
26
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, purpose-based sampling and allocation to 2 groups of case and control are done by randomization using the coin toss method and placement in blocks of 4. In this way, the coin is tossed first, if the same group is chosen twice in a row by chance, the other two choices will definitely be the opposite group. This action is done to fix the error of repeating one coin after another, so that in each group of four there must be two control groups and a case. Since our sample size is 26 people, 13 people are in the control group and 13 people are in the case group. Therefore, after 6 blocks of 4, of the 2 people who remain, the first person is determined by throwing a coin and the second person is added to the opposite group.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is a blind strain and the evaluator is not aware of the groups
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee In Research Faculty of Dentistry, Azad University of Medical Sciences, Tehran
Street address
No 9, 9th Neyestan, Pasdaran Street
City
Tehran
Province
Tehran
Postal code
1946853314
Approval date
2023-10-14, 1402/07/22
Ethics committee reference number
IR.IAU.DENTAL.REC.1402.096
Health conditions studied
1
Description of health condition studied
Alveolar ridge width
ICD-10 code
K08.2
ICD-10 code description
Atrophy of edentulous alveolar ridge
Primary outcomes
1
Description
Alveolar ridge width
Timepoint
At the beginning of the study (before the intervention) and six months after the intervention
Method of measurement
On the cast prepared after molding using a gauge with an accuracy of 10 mm
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: On the day of the surgery, after placing the Osstem brand implant made in South Korea, the healing piece is placed on it, and the surrounding area is shaped with light cure composite in the silent shape of the desired tooth, and the area is sutured.
Category
Treatment - Devices
2
Description
Control group: On the day of the surgery, after placing the Osstem brand implant made in South Korea, only the prefabricated healing piece is placed and the area is sutured.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Islamic Azad University dental branch Tehran
Full name of responsible person
Dr. Nima Nddafpour
Street address
No.9, 9th Neyestan Ave, Pasdaran Blvd
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
nima.na04@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Arash Azizi
Street address
No.9, 9th Neyestan Ave, Pasdaran Blvd
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 912 225 8219
Email
drarashazizi@yahoo.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
Full name of responsible person
DR. Nima Naddafpour
Position
Periodontist_ assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Dentistry
Street address
No.9, 9th Neyestan Ave, Pasdaran Blvd
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
nima.na04@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Nima Naddafpour
Position
Periodontist_ assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No.9, 9th Neyestan Ave, Pasdaran Blvd
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
nima.na04@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Nima Naddafpour
Position
Periodontist_ assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No.9, 9th Neyestan Ave, Pasdaran Blvd
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
nima.na04@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