Clinical comparison of two different approach of De-epithelialization of free gingival graft using surgical blade and diamond bur in thickness and width of peri-implant keratinized tissue
Comparison of the width and thickness of peri-implant keratinized tissue following the use of de-epithelialized free gingival graft using surgical blade and diamond bur
Design
The study was a single-blind splith-mouth clinical trial and the available non-random sampling method was used.
Settings and conduct
The study was performed on 20 patients referred to the periodontics department of Islamic Azad University, Isfahan Branch before receiving the final implant prosthesis.
The recipient site was prepared by the envelope flap technique.
to prepare the d-fgg by bur, the superficial epithelial layer removed by diamond bur and a high-speed handpiece to the depth of about 0.5-1 mm, then the tissue is separated from the palate and to prepared the d-fgg by blade, the graft is separated from the palate in partial thickness, then the superficial epithelial layer is removed using a blade.
The connective tissue is guided to recipient site by absorbable monofilament 0-5 suture and sutured to the flap.
Participants/Inclusion and exclusion criteria
inclusion criteria:
1.Partial edentulous patient with at least 2 dental implants
2.Insufficient keratinized tissue around implants (width less than 2 mm and / or thickness less than 2 mm)
3.Presence of buccal bone around the implant
4.Good oral hygiene
5.Identical implants in terms of shape and brand in each patient
exclusion criteria:
1.uncontrolled systemic disease
2.Smoking more than 10 cigarettes a day
3.History of mental disorder
4.Periodontal disease or local inflammation
5.History of implant failure or tissue grafting
6.Poor oral health
7.Drugs affect on tissue repair
8.History of tissue augmentation in the area
Intervention groups
Intervention : de-epithelialization of the fgg using diamond bur
Control : de-epitelialization of the fgg using surgical blade
Main outcome variables
width of keratinized tissue
thickness of keratinized tissue
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220427054680N1
Registration date:2022-06-20, 1401/03/30
Registration timing:retrospective
Last update:2022-06-20, 1401/03/30
Update count:0
Registration date
2022-06-20, 1401/03/30
Registrant information
Name
nasim maghamipour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 1535 4053
Email address
n.maghamipour@khuisf.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-16, 1400/07/24
Expected recruitment end date
2021-12-25, 1400/10/04
Actual recruitment start date
2021-10-17, 1400/07/25
Actual recruitment end date
2022-01-23, 1400/11/03
Trial completion date
empty
Scientific title
Clinical comparison of two different approach of De-epithelialization of free gingival graft using surgical blade and diamond bur in thickness and width of peri-implant keratinized tissue
Public title
Clinical comparison of two different approach of De-epithelialization of free gingival graft using surgical blade and diamond bur
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Partial edentulous patient with at least 2 dental implants ready to receive prosthesis
Insufficient keratinized tissue around implants (keratinized gingival width less than 2 mm and / or keratinized gingival thickness less than 2 mm)
Presence of buccal bone around the implant
Good oral hygiene (FMPS, FMBS <25%)
Identical implants in terms of shape and brand in each patient
Exclusion criteria:
Existence of uncontrolled systemic disease
Smoking more than 10 cigarettes a day
History of mental disorder
Periodontal disease or local inflammation
History of implant failure or tissue grafting in the area
Poor oral health (25%> FMBS)
Consumption of drugs effective in tissue repair
History of soft or hard tissue augmentation in the area
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
20
More than 1 sample in each individual
Number of samples in each individual:
2
Case and control groups as split-mouth in one person
Actual sample size reached:
20
More than 1 sample in each individual
Actual sample size in each individual:
2
Case and control groups as split-mouth in one person
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The person who collected the data and evaluated the outcome was someone other than the surgeon and is kept blind
Placebo
Not used
Assignment
Parallel
Other design features
split-mouth
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University - Isfahan Branch (Khorasgan)
Street address
Arghavaniyeh street, Eastern Jey Street
City
isfahan
Province
Isfehan
Postal code
8155139998
Approval date
2021-11-13, 1400/08/22
Ethics committee reference number
IR.IAU.KHUISF.REC.1400.244
Health conditions studied
1
Description of health condition studied
peri-implant keratinized tissue
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
width of keratinized tissue
Timepoint
At the beginning of the study (before the intervention) and 1, 3 and 6 months after surgery
Method of measurement
Compass and digital caliper
2
Description
thickness of keratinized tissue
Timepoint
At the beginning of the study (before the intervention) and 1, 3 and 6 months after surgery
Method of measurement
Endodontic file and digital caliper
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: de-epithelialization of the free gingival graft using diamond bur
Category
Treatment - Surgery
2
Description
Control group: de-epitelialization of the free gingival graft using surgical blade
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Periodontology, Dental School,Isfahan Branch, Islamic Azad University
Full name of responsible person
Nasim Maghamipour
Street address
Boulevard, Arghavanieh Street, Eastern Jey Street
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 1535 4053
Email
maghamipour2013@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Research Vice- Chancellor of Islamic Azad University Isfahan Branch
Street address
Khorasgan Branch, Islamic Azad University, University Boulevard, Arghavanieh Street, Eastern Jey Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 912 293 2462
Email
maghamipour2013@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Esfahan 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
Islamic Azad University
Full name of responsible person
Nasim Maghamipour
Position
Resident of periodontics
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Khorasgan Branch, Islamic Azad University, University Boulevard, Arghavanieh Street, Eastern Jey Street, Isfahan
City
Esfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 1535 4053
Fax
Email
n.maghamipour@khuisf.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Nasim Maghamipour
Position
Resident of periodontics
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Khorasgan Branch, Islamic Azad University, University Boulevard, Arghavanieh Street, Eastern Jey Street, Isfahan
City
Esfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 1535 4053
Fax
Email
n.maghamipour@khuisf.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Nasim Maghamipour
Position
Resident of periodontics
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Khorasgan Branch, Islamic Azad University, University Boulevard, Arghavanieh Street, Eastern Jey Street, Isfahan
City
Esfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 1535 4053
Fax
Email
n.maghamipour@khuisf.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
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The documentation for this study is available to other researchers. Available documents will include data related to all studied variables (except patients' personal information) and in the form of SPSS file.
When the data will become available and for how long
3 months after printing the results
To whom data/document is available
The information of this research can be shared with all academic researchers.
Under which criteria data/document could be used
For research and clinical use
From where data/document is obtainable
Ways of communication with the responsible researcher: Email: n.maghamipour@khuisf.ac.ir
What processes are involved for a request to access data/document
En After coordination with the responsible researcher, the requested data will be sent within one month.