Determination of the success rate of dental implants after alveolar buccal cortex reconstruction using palatal bone graft
Design
Clinical trial, convenience sampling, preliminary study in 15 patients
Settings and conduct
In 15 patients referred to the oral, maxillofacial surgeon's office who are candidates for implants in maxillary incisors and have buccal defects; After tooth extraction and implant placement, crushed palatal bone graft will be used to reconstruct the buccal wall, and xenogeneic graft and collagen membrane will be used on it for guided bone regeneration (GBR).The success rate of these implants will be evaluated by examining the rate of bone resorption, the rate of failure, the rate of dehiscence and the rate of wound infection in the 6-month follow-up after surgery.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1) Candidate to receive an implant in maxillary incisors
2) Loss of buccal cortex of implant during surgery up to half of the implant
3) Availability of palatal bone for transplantation
Exclusion criteria:
1) History of previous surgery in the desired area
Intervention groups
After extracting the teeth and placing the implant , the palatal graft will be harvested using the trephine method. The graft will be placed over the missing buccal area. Xenogenous graft and collagen membrane for GBR will be used on it. Amoxicillin, ibuprofen, chlorhexidine 0.12% mouthwash will be prescribed.
Main outcome variables
The rate of bone resorption
Implant failure
Envelope depth
wound dehiscence
wound infection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221111056472N1
Registration date:2022-12-15, 1401/09/24
Registration timing:prospective
Last update:2022-12-15, 1401/09/24
Update count:0
Registration date
2022-12-15, 1401/09/24
Registrant information
Name
Parisa Seydabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3334 2127
Email address
parisaseydabadi6@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-22, 1401/10/01
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
Evaluation of the success rate of dental implants after Alveolar buccal cortex Reconstruction using Palatal bone graft
Public title
Application of Palatal bone graft in dental implants
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
candidate to receive an implant in the anterior of the maxilla (incisors)
Loss of buccal cortex of implant during surgery up to half of the implant
Intactness of other bone walls
Availability of palatal bone for transplantation
Intact soft tissue for implant coverage
The patient's health in terms of systemic issues
Exclusion criteria:
Non-cooperation of the patient in terms of compliance with health issues
Failure to visit the patient for follow-up
Previous surgical history of the desired area
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
15
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
Ethics Committee of Semnan University of Medical Sciences
Street address
Research and Technology Vice-Chancellor, Central Headquarters of Semnan University of Medical Sciences, Basij Blvd.
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2022-10-25, 1401/08/03
Ethics committee reference number
IR.SEMUMS.REC.1401.180
Health conditions studied
1
Description of health condition studied
Placement of dental implants in the anterior of the maxilla after reconstruction of the buccal cortex using palatal bone grafting
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The amount of bone loss
Timepoint
Three months and six months after surgery
Method of measurement
Periapical radiograph
2
Description
Implant success
Timepoint
Three months and six months after surgery
Method of measurement
observation
3
Description
probing depth of the pocket on the buccal surface of the implant
Timepoint
Three months and six months after surgery
Method of measurement
Michigan-O periodontal probe William's Color Coded Marking
4
Description
Wound dehiscence
Timepoint
Three months and six months after surgery
Method of measurement
observation
5
Description
Wound infection
Timepoint
Three months and six months after surgery
Method of measurement
observation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In 15 patients who visited the oral, maxillofacial surgeon's office, after teeth extraction and implant placement with the standard protocol, the palatal bone graft will be harvested using the trephine (crushed bone) method. The graft will be placed over the missing buccal area. Xenogenous bone graft and collagen membrane for guided bone regeneration (GBR) will be used on it. The soft tissue will be returned to the grafted area and fixed in place with a simple suture. For patients, Amoxicillin antibiotic every 8 hours for one week, Ibuprofen pain reliever every 6 hours for 48 hours and Chlorhexidine 0.12% mouthwash twice a day for one week will be prescribed.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Oral, maxillofacial surgeon's office
Full name of responsible person
Mohammad Esmaeilinejad
Street address
2nd floor, Ferdous commercial service complex, Moalem square, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3514898533
Phone
+98 23 3334 0786
Email
esmaeelnejad@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Majid Mirmohammadkhani
Street address
Research and Technology Vice-Chancellor, Central Headquarters of Semnan University of Medical Sciences, Basij Blvd.
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
majidmirmohammadkhani@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Semnan University of Medical Sciences
Proportion provided by this source
1
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
Semnan University of Medical Sciences
Full name of responsible person
Parisa Seydabadi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
2nd floor, No. 28, Sajjad II Alley, Sajjad Street, Twenty meters of Vahdat Boulevard
City
Semnan
Province
Semnan
Postal code
3514898533
Phone
+98 23 3334 2127
Email
parisaseydabadi6@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Parisa Seydabadi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
2nd floor, No. 28, Sajjad II Alley, Sajjad Street, Twenty meters of Vahdat Boulevard
City
Semnan
Province
Semnan
Postal code
3514898533
Phone
+98 23 3334 2127
Email
parisaseydabadi6@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Parisa Seydabdi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
2nd floor, No. 28, Sajjad II Alley, Sajjad Street, Twenty meters of Vahdat Boulevard
City
Semnan
Province
Semnan
Postal code
3514898533
Phone
+98 23 3334 2127
Email
parisasiin@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