Buccal bone Dimensional changes in immediate implant placement with and without bone graft with immediate provisionalization: A Randomized Clinical Trial
Evaluation of Buccal bone dimensional changes in immediate implant placement with and without bone graft with immediate provisionalization
Design
A randomized clinical trial with control and intervention groups, with parallel groups, one-way blind, Balanced Block Randomization of samples with 4 blocks size, on 30 patients
Settings and conduct
this study will be performed on patients who are candidates for anterior tooth extraction and immediate implant placement at a private clinic. After evaluating the patients according to the inclusion and exclusion criteria, an immediate implant with an immediate temporary prosthesis with and without a bone graft will be placed at the tooth extraction site and then a radiographic evaluation will be done to measure the bone changes.
Participants/Inclusion and exclusion criteria
inclusion criteria for this study are as follows: 1) Patients require extraction of an anterior maxillary tooth and the possibility of immediate placement of implants in the same site 2) Existence of buccal bone and 3) Gap space more than 2 mm between the implant and buccal bone.
Similarly, exclusion criteria include 1) the presence of periodontal disease 2) the presence of systemic or local diseases that may interfere with bone repair (including diabetes, osteoarthritis, hypothyroidism, hyperparathyroidism, and osteoporosis)
3) Use of drugs that prevent implant placement or interfere with implant osteointegration (including bisphosphonates) 4) Pregnancy 5) Drug Addiction and smoking 6) Acute infection at the implant site 7) Patient under Radiotherapy and 8) patients with parafunctional habits such as Bruxism or Clenching
Intervention groups
1) Intervention group: Immediate implant placement + SigmaGraft-InterOss xenograft made in the USA
2) Control group: Immediate implant placement + without any bone graft material.
Main outcome variables
bone dimensional changes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211119053106N1
Registration date:2021-12-06, 1400/09/15
Registration timing:prospective
Last update:2021-12-06, 1400/09/15
Update count:0
Registration date
2021-12-06, 1400/09/15
Registrant information
Name
Salar Chaychi Salmasi
Name of organization / entity
Department of Research and Development, Farinroshaan Medical & Health Co. LTD., Tehran, Iran
Country
Iran (Islamic Republic of)
Phone
+98 21 6642 4869
Email address
salar.chaychis@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-21, 1400/11/01
Expected recruitment end date
2022-08-22, 1401/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Buccal bone Dimensional changes in immediate implant placement with and without bone graft with immediate provisionalization: A Randomized Clinical Trial
Public title
Buccal bone Dimensional changes in immediate implant placement
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients require removal of a maxillary anterior tooth and the possibility of immediate implant placement in the same site
presence of buccal bone
Gap space greater than 2 mm between implant and buccal bone
Exclusion criteria:
periodontal disease
presence of systemic or local diseases that may interfere with bone repair
Use of drugs that prevent implant placement or interfere with implant osteointegration
Pregnancy
addiction to Drug and smoking
Presence of acute infection at the implant site
Patient undergoing radiotherapy
Patients with parafunctional habits such as Bruxism or Clenching
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be randomly allocated (1:1) to group 1 (with bone graft) and group 2 (without bone graft). The randomization sequence will be generated by an independent investigator using computer software (www.randomization.com). Balanced Blocked randomization will be used, with a block size of 4. The surgeon will open sequentially numbered, sealed envelopes only after the implants will be inserted on the day of the surgeries. Although the surgeon will be aware of the allocated arm, the radiographic outcome assessor will be kept blinded to the allocation.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants (patients) are completely blind to whether they are in the control or intervention group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Islamic Azad University - Dental Branch Tehran - Iran
Street address
No. 9, School of Dentistry, Tehran Azad University of Medical sciences, 9th Neyestan, Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1946853314
Approval date
2021-11-10, 1400/08/19
Ethics committee reference number
IR.IAU.DENTAL.REC.1400.096
Health conditions studied
1
Description of health condition studied
Immediate implant
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Bone dimensional Changes
Timepoint
At the beginning of the study and 6 months after the intervention (immediate implant placement)
Method of measurement
Cone Beam Computed Tomography Pictures
Secondary outcomes
1
Description
Secondary outcomes: 1) Implant failure: Any implant that is removed after placement due to mobility, progressive marginal bone resorption, infection, or any mechanical complication (e.g., implant fracture). 2) Prosthesis failure: All prosthesis that fail with the implant or can not be placed due to implant failure or will be replaced for any reason. 3) Biological or prosthetic complications
Timepoint
6 months after intervention (implant placement)
Method of measurement
Clinical examination and Cone Beam Computed Tomography images
Intervention groups
1
Description
Intervention group: Immediate implant placement + placement of SigmaGraft-InterOss bone graft material made in the USA in the distance between implant and buccal bone.
Category
Treatment - Surgery
2
Description
Control group: Immediate placement of implant + without bone graft
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
school of dentistry, Tehran Azad University of Medical Sciences
Full name of responsible person
Salar Chaychi Salmasi
Street address
No 9, School of Dentistry, Tehran Azad University of Medical Sciences, 9th Neyestan, Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
salar.chaychis@gmail.com
2
Recruitment center
Name of recruitment center
Dorsa Private Dental Clinic
Full name of responsible person
Ali Hassani
Street address
Amin Tower, Asef, Zaferanie,Tehran
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2217 1000
Email
drhassani.omfs@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Arash Azizi
Street address
No. 9, School of Dentistry, Tehran Azad University of Medical Sciences, 9th Neyestan, Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
salar.chaychis@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
Full name of responsible person
Salar Chaychi Salmasi
Position
Dentistry Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 115, Kalhor St, Zare St, Azadi St
City
Tehran
Province
Tehran
Postal code
1311765671
Phone
+98 21 6642 4869
Email
Salar.chaychis@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Salar Chaychi Salmasi
Position
Dentistry Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 115, Kalhor Ave, Zare Ave, Azadi Str
City
Tehran
Province
Tehran
Postal code
1311765671
Phone
+98 21 6642 4869
Fax
Email
salar.chaychis@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Salar Chaychi Salmasi
Position
Dentistry Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 115, Kalhor Ave, Zare Ave, Azadi Str
City
Tehran
Province
Tehran
Postal code
1311765671
Phone
+98 21 6642 4869
Fax
Email
salar.chaychis@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is 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
Not applicable
Title and more details about the data/document
All potential data can be shared after the participants are unidentifiable
When the data will become available and for how long
Access period starts from 2024
To whom data/document is available
Only for researchers working in academic and scientific institutions