Study of buccal bone dimensional changes by Flapless immediate implantation and filling the buccal gap space with xenograft material by Cone bean computed tomography Technique
This is an open, randomized, controlled, experimental Clinical Trial study with 32 patients in two parallel groups. The Main Objective: Study of buccal bone dimentional changes in Flapless immediate implantation by CBCT. Secondary Objective: Evaluation the effects of xenograft on bone remodeling.
Inclusion criteria: Patients with implants request in the anterior maxillary area; Patients over 18 years; At least 3-5 mm keratinized gingiva and confirmed the presence of buccal bone after tooth extraction. Exclusion criteria: patients with any systemic disease which affecting the healing process; or any active infection in the region or acute apical lesions; And probing depth more than 4 mm in the adjacent teeth.
After local anesthesia tooth removal was carried out atraumatic without elevation of a mucoperiosteal flap and with use of periotome and forceps, then a curette is used to ensure the integrity of the buccal bone plate.
Standard drilling procedures are performed with Dentium system. The platforms of the implants were located 1.0–2.0 mm below the buccal bone crest level.The width of the gap between the implant surface and the inner and outer side of the bone wall and the buccal bone thickness at crest and 2 mm under it will be measure using a calliper and gauge, then the space wil be filled by xenograft or remained without any material and tightening healing abutment then suture the area at final.
The dimention of buccal bone plate will be assessed by CBCT at three time points: pre-surgery (T0), 24 h after surgery (T1), and 4 months postoperative (T2).
Measurements will be taken at the cross sectional views in the middle of the anterior maxillary teeth.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201606188898N3
Registration date:2016-09-09, 1395/06/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-09-09, 1395/06/19
Registrant information
Name
Mojgan Paknejad
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8801 5801
Email address
mpaknejad@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2016-03-19, 1394/12/29
Expected recruitment end date
2017-01-18, 1395/10/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of buccal bone dimensional changes by Flapless immediate implantation and filling the buccal gap space with xenograft material by Cone bean computed tomography Technique
Public title
Evaluation of the bone dimensional changes in immediate implant placement by CBCT
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with implants request in the anterior maxillary area; Patients over 18 years; optimal oral hygiene; At least 3-5 mm keratinized gingiva and confirmed the presence of buccal bone after tooth extraction.
Exclusion criteria: patients with any systemic disease which affecting the healing process; Smoker; Bruxer; And also any active infection in the region or acute apical lesions; And probing depth more than 4 mm in the adjacent teeth or the presence of the implant adjacent the area.
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
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 Tehran University of Medical Sciences
Street address
Central Organization of Tehran University of Medical Sciences, keshavarz Blvd, Qods Ave
City
Tehran
Postal code
Approval date
2016-08-06, 1395/05/16
Ethics committee reference number
IR.TUMS.VCR.REC.1395.389
Health conditions studied
1
Description of health condition studied
Study of buccal bone dimensional changes of the missing teeth in the maxillary anterior region
ICD-10 code
K08.1
ICD-10 code description
Loss of teeth due to accident, extraction or local periodontal disease
Primary outcomes
1
Description
buccal bone dimentional changes at the crest and 2mm under the crest
Timepoint
Immediately after implant placement and 4 months after treatment.
Method of measurement
By using CBCT radiography
Secondary outcomes
1
Description
Buccal bone height changes
Timepoint
Immediately after implant placement and 4 months after treatment.
Method of measurement
By using CBCT radiography
Intervention groups
1
Description
Filling the gap with xenograft following implant placement
Category
Treatment - Drugs
2
Description
Do not use bone material in the control group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental School, Tehran University of Medical Sciences
Full name of responsible person
Mr. Hossein Sabohi
Street address
Enghelab Square, North Karegar Street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mrs Samaneh Zolfaghari
Street address
Central Organization of Tehran University of Medical Science, keshavarz Blvd, Qods Ave
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Samira Hajheidary
Position
DDS, Postgraduate student of Periodontology
Other areas of specialty/work
Street address
Enghelab Square, North Karegar Street
City
Tehran
Postal code
Phone
+98 21 8801 5801
Fax
+98 21 8801 5800
Email
S.hajheidary@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mojgan Paknejad
Position
DDS, MSc, periodontist
Other areas of specialty/work
Street address
Enghelab Square, North Karegar Street
City
Tehran
Postal code
Po. Code:14399-55991
Phone
+98 21 8801 5801
Fax
+98 21 8801 5800
Email
mpaknejad@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Samira Hajheidary
Position
DDS, Postgraduate student of Periodontology
Other areas of specialty/work
Street address
Enghelab Square, North Karegar Street
City
Tehran
Postal code
Po. Code:14399-55991
Phone
+98 21 8801 5950
Fax
Email
s.hajheidary@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)