Comparison of gelfoam and bone inducing material in preventing marginal bone loss in immediate implant insertion of anterior teeth after 3,6 and 9 mounths.
Design
In this clinical trial 60 patients having the inclusion criteria divided randomly in two groups using hexagonal blocks. After placement of the anterior immediate implant, the gap will filled with gelfoam in the intervention group and with bone material in the control group. Both groups will be followd 3,6 and 9 month after placement.
Settings and conduct
patients who are candidate for immediate implantation who will refer to Semnan School of Dentistry during the study period will be enrolled into the trial. Tooth will be extracted flaplessly for all patients. The implant surgery will be done and the implant will be inserted. After the procedure periapical radiographic imaging will be taken. Patients will be examined by an oral and maxillofacial surgeon and a prosthodontist.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients who are candidate for immediate implantation with at least 2 mm attached gingiva width and no sign of fistula or infection will be enrolled into the trial.Exclusion criteria: Systemic disease; addiction; bruxism;using special drugs; bone graft candidate; presence of dehiscence and fenestration and insufficient buccal bone(minimum 1mm buccal bone is necessary.)
Intervention groups
Intervention group: placement of immediate implant and using gelfoam for filling the gap.
Main outcome variables
Buccal table bone resorption
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190830044644N1
Registration date:2019-11-10, 1398/08/19
Registration timing:registered_while_recruiting
Last update:2019-11-10, 1398/08/19
Update count:0
Registration date
2019-11-10, 1398/08/19
Registrant information
Name
Yasaman Sahraeeyan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3348 5631
Email address
yasaman.sahraeeyan2015@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-23, 1398/08/01
Expected recruitment end date
2020-01-21, 1398/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Gelfoam And Bone Inducing Material in Preventing Marginal Bone Loss in Immediate Implant Insertion of Anterior Teeth
Public title
Gelfoam And Bone Inducing Material in Preventing Marginal Bone Loss in Immediate Implant Insertion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients who candidates for immediate implant
at least 2 mm attached gingiva width
no sign of fistula or infection
Exclusion criteria:
systemic disease
addiction
bruxism
using special drugs
bone graft candidate
presence of dehiscence and fenestration
insufficient buccal bone
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients divided randomly in two groups by using hexagonal blocks.
Blinding (investigator's opinion)
Not 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 Semnan University of Medical Sciences
Street address
Vice chancellor for research, Semnan University of Medical Sciences building, Basij Blvd
City
Semnan
Province
Semnan
Postal code
35198-99951
Approval date
2019-05-21, 1398/02/31
Ethics committee reference number
IR.SEMUMS.REC.1398.098
Health conditions studied
1
Description of health condition studied
Comparison of alveolar bone resorption while using gelfoam and bone material in dental socket.
ICD-10 code
Z96.5
ICD-10 code description
Presence of tooth-root and mandibular implants
Primary outcomes
1
Description
Amount of alveolar bone resorbtion
Timepoint
3,6 and 9 months after implant insertion
Method of measurement
Priapical Radiographic imaging
Secondary outcomes
empty
Intervention groups
1
Description
Control group: After placement of immediate implant in this group, bone material is used to fill the gap between implant and the buccal bone.
Category
Treatment - Other
2
Description
Intervention group: After placement of immediate implant in this group, Gelfoam is used to fill the gap between implant and the buccal bone.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Semnan dental university
Full name of responsible person
Anahita Shahi
Street address
Faculty of Dentistry, Semnan University of Medical Sciences, Hefdah Shahrivar St., Saadi Square
City
Semnan
Province
Semnan
Postal code
3519-99951
Phone
+98 23 3333 4657
Email
Anahita.shahi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Nazila Ameli
Street address
Research center, Semnan Dental School, 17 Shahrivar Blvd
City
Semnan
Province
Semnan
Postal code
35198-99951
Phone
+98 23 3336 4363
Email
nazilaa.aameli@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Anahita Shahi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Periodontist
Street address
Semnan Dental School, 17 Shahrivar Blvd
City
Semnan
Province
Semnan
Postal code
35198-99951
Phone
+98 23 3333 4657
Email
Anahita.shahi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Anahita Shahi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Periodontist
Street address
Semnan Dental School, 17 Shahrivar Blvd
City
Semnan
Province
Semnan
Postal code
35198-99951
Phone
+98 23 3333 4657
Email
Anahita.Shahi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Yasaman sahraeeyan
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Semnan Dental School, 17 Shahrivar Blvd
City
Semnan
Province
Semnan
Postal code
35198-99951
Phone
+98 23 3333 4657
Email
yasaman.sahraeeyan2015@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