Evaluation of Keratinized mucosa changes with buccal base modified palatal flap in maxillary anterior implants
Design
Clinical trial without control group based on community and pragmatic.
Settings and conduct
10 patients who have referred to the implant department of Tabriz Dental faculty for treatment and have inclusion criteria and no exclusion criteria will be selected.Patients in this study are randomly selected,Surgery is performed by a maxillofacial surgeon with 5 years of specialized experience
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Candidate for implant placement in maxillary central and lateral teeth, the width of the keratinized mucosa is less than 3 mm, the thick of the keratinized mucosa are less than 1 mm, the minimum width of the bone should be 4.5 mm, the minimum height of the bone is 12 mm, and more than 6 months have passed since tooth extraction.
Exclusion criteria:
Uncontrolled periodontal disease, presence of teeth in the implant site, uncontrolled systemic disease, smoking history in the last 6 months, pregnancy and lactation, patients with connective tissue disease, and radiotherapy and chemotherapy
Intervention groups
Intervention group: the split-thickness crestal incision is made in the top of the crest so that it is 0.5 mm towards the palatal,Supra-periosteal dissection is then given up to 2 cm on the palatal side. At the end of the palatal dissection, a periosteal incision is made and the periosteum and connective tissue are moved to the buccal that is, the palatal connective tissue is rolled and placed behind the buccal mucosa and sutured by absorbable sutures. The fixture is then placed in a standard surgical manner so that the initial torque is higher than 30n / cm
Main outcome variables
Width of keratinized gingiva; Thickness of keratinized gingiva
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130710013938N6
Registration date:2021-08-22, 1400/05/31
Registration timing:retrospective
Last update:2021-08-22, 1400/05/31
Update count:0
Registration date
2021-08-22, 1400/05/31
Registrant information
Name
Mohamadali Ghavimi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 5968
Email address
ghavimim@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-20, 1400/02/30
Expected recruitment end date
2021-07-21, 1400/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Keratinized mucosa changes with buccal base modified palatal flap in maxillary anterior implants
Public title
Evaluation of modified palatal flap surgery to improve gingival health
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate for implant placement in maxillary central and lateral teeth
The width of the keratinized mucosa is less than 3 mm
The thick of the keratinized mucosa are less than 1 mm
The minimum width of the bone should be 4.5 mm
The minimum height of the bone is 12 mm
More than 6 months have passed since tooth extraction
Exclusion criteria:
Uncontrolled periodontal disease
Presence of teeth in the implant site
Uncontrolled systemic disease
Smoking history in the last 6 months
Pregnancy and lactation
Patients with connective tissue disease
Radiotherapy and chemotherapy
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
10
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 Tabriz University of Medical Sciences
Street address
Tabriz dental faculty, Golgasht St.,
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Approval date
2021-04-15, 1400/01/26
Ethics committee reference number
IR.TBZMED.REC.1400.023
Health conditions studied
1
Description of health condition studied
Periodontal health around dental implants
ICD-10 code
Z96.5
ICD-10 code description
Presence of tooth-root and mandibular implants
Primary outcomes
1
Description
Thickness of keratinized gingiva
Timepoint
AT the beginning of the study, 6 weeks after completion of the intervention and 12 weeks after completion of the intervention
Method of measurement
Measured by endodontic spreader No. 25
2
Description
Width of keratinized gingiva
Timepoint
AT the beginning of the study, 6 weeks after completion of the intervention and 12 weeks after completion of the intervention
Method of measurement
Measured by a calibrated gauge.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The crestal incision is applied in a split-thickness at the top of the crest so that it is 0.5 mm towards the palatal, then the supra-periosteal dissection is given up to 2 cm towards the palatal. At the end of palatal dissection, a periosteal incision is made and the periosteum and connective tissue are moved to the buccal base, ie the palatal connective tissue is rolled and placed behind the buccal mucosa and sutured by absorbable suture. The fixture is then placed in a standard surgical manner so that the initial torque is higher than 30n / cm. It should be noted that if the torque was lower than this value, the patient will be excluded from the study and his surgery will be performed in two stages. By placing the fixture as standard, healing abutment with a diameter of 4.5 cuff 4 and a height of 4.5 mm is placed. (One-step surgical procedure)
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry, Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Ali Ghavimi
Street address
Tabriz dental faculty , Golgasht St.,
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
Ghavimim@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Samiei
Street address
Tabriz University of Medical Sciences, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7310
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Mohammad Ali Ghavimi
Position
Assistant Professor of Oral and Maxillofacial Surgery
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Oral and Maxillofacial Department, Second floor, Ememreza Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 1335 5965
Fax
Email
ghavimim@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Mohamadali Ghavimi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Oral and Maxillofacial Department, Second floor, Ememreza Hospital, Gholgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5968
Fax
+98 41 3335 5969
Email
ghavimim@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
ِDr Mohamadali Ghavimi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Others
Street address
Oral and Maxillofacial Department, Second floor, Ememreza Hospital, Gholgasht street.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5968
Fax
+98 41 3335 5969
Email
ghavimim@tbzmed.ac.ir
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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be published after unidentifying individuals.
When the data will become available and for how long
3 months after publishing the results
To whom data/document is available
It will be accessible to all researchers
Under which criteria data/document could be used
The use of data with reference to the source is unrestricted
From where data/document is obtainable
1. Dr Mohammadali Ghavimi/Ghavimim@tbzmed.ac.ir
2. Dr Mahdi Sadeghi/ m.sadeghi13@gmail.com
What processes are involved for a request to access data/document
After receiving the email containing the data request from the researcher, the data will be provided to the researcher within a period of one month.