Comparison morbidity in donor site and color matching in recipient site between two different free connective tissue graft harvesting technique from palate
Comparison complications after surgery and color matching of free connective tissue graft between two different methods of harvesting graft from the palate
Design
This study is a clinical trial with a control group, with parallel groups, a blind strain, split mouth and randomized. Sealed envelopes have been used for randomization.
Settings and conduct
The patient and the evaluators in the 6-month follow-up are blind. Only the researcher is aware of the used methods
Participants/Inclusion and exclusion criteria
1- Bilateral areas in the jaw where the teeth have gingival recession
2- The bilateral areas affected by the recession should have approximately the same recession depth
3- There should be no interdental soft tissue CAL in the areas with recession (Miller 1 and 2)
4- The thickness of the palate in people should be at least 2 mm
5- Absence of signs of inflammation in the teeth located in the area of gingival recession
6- The presence of a sulcus with a depth of < 3 mm
7- People must be over 18 years of age
8- There is no history of harvesting the graft from palate
Smokers who smoke more than 10 cigarettes per day, pregnant women, people who take drugs that affect periodontal tissues and healing and teeth in the surgical area with mobility or improper root treatment were excluded from the study.
Intervention groups
The surgical technique in the control group is the trap door method and in the test group, the method is harvesting epithelialized graft and then de-epithelialization outside the mouth.
Main outcome variables
1- Comparison of the amount of pain in the donor sites
2- The comparison of the amount of shrinkage in the recipient sites
3- Comparison of color matching in the resulting tissue at the recipient site
4- Comparison of the thickness of the resulting tissue in the recipient site
5- Comparison of coverage obtained for gingival recession
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230102057017N1
Registration date:2023-01-30, 1401/11/10
Registration timing:registered_while_recruiting
Last update:2023-01-30, 1401/11/10
Update count:0
Registration date
2023-01-30, 1401/11/10
Registrant information
Name
Amine Beymouri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8835 1170
Email address
aminebeymouri@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-16, 1401/10/26
Expected recruitment end date
2023-08-21, 1402/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison morbidity in donor site and color matching in recipient site between two different free connective tissue graft harvesting technique from palate
Public title
Comparison of 2 methods of gingival connective tissue grafting in terms of patient comfort and grafted tissue quality
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Bilateral areas in the jaw where the teeth have gingival recession. If the number of teeth affected by recession on both sides of the jaw is not the same, the area with a smaller size is the criterion, and the same number of teeth is considered on the opposite side of the surgical site
The bilateral areas affected by the analysis should have approximately the same recession depth
There should not be CAL interdental soft tissue in the areas with recession (Miller 1 and 2)
The presence of a sulcus with a depth < 3 mm
The thickness of the palate in people should be at least 2 mm
Absence of signs of inflammation in the teeth located in the area of gum augmentation (such as BOP, enlargement, pus) or if there is, performing periodontal treatment and controlling the symptoms
People over 18 years old
There is no history of graft harvesting from palate
Exclusion criteria:
Smokers who smoke more than 10 cigarettes per day
Pregnant women
People who take drugs that affect periodontal tissues and healing of tissues
Teeth in the surgical area with mobility or improper root treatment
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
12
More than 1 sample in each individual
Number of samples in each individual:
2
Connective tissue graft surgery
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the donor and recipient areas are both on the same side. To determine the direction and type of surgery, trap door-left, trap door-right, deepithelization-right and deepithelization-left are written in 4 envelopes. On the day of the surgery and just before the surgery, one of the envelopes is removed to determine the direction and type of surgery for the first session. About 4 to 2 weeks later (depending on the extent of recovery and improvement of the patient's pain symptoms), another surgical procedure will be performed on the opposite side.
Blinding (investigator's opinion)
Single blinded
Blinding description
The patient and the evaluators in the 6-month follow-up are unaware of the surgical method used in each side. Only the researcher who performs the surgeries herself is aware of the method used in each direction.
Placebo
Not used
Assignment
Parallel
Other design features
This study will be conducted as a split mouth randomized controlled clinical trial. The surgical technique in the control group was the trap door method and in the test group, the preparation method was epithelialization and then de-epithelialization outside the mouth.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical sciences
Street address
North Karegar Street, Dentistry Faculty of Tehran University Medical Sciences
City
Tehran
Province
Tehran
Postal code
1439955991
Approval date
2021-08-01, 1400/05/10
Ethics committee reference number
IR.TUMS.DENTISTRY.REC.1400.197
Health conditions studied
1
Description of health condition studied
Gingival recession
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Evaluation the pain level of the patient in the donor area which is measured based on the Visual Analogue Scale
Timepoint
The third and seventh day after surgery
Method of measurement
Visual Analogue Score
Secondary outcomes
1
Description
Graft shrinkage in recipient site
Timepoint
6 months after surgery
Method of measurement
The ratio of the grafted area in recipient site to the initial area of the graft before suturing, which is measured by Image J software
2
Description
Evaluating the degree of color matching in the recipient area
Timepoint
6 months after surgery
Method of measurement
The score of 3 blind professor regarding the method used and averaging them
3
Description
Evaluating the thickness of grafted site
Timepoint
6 months after surgery
Method of measurement
Ultrasonography
Intervention groups
1
Description
Intervention group: The group in which graft harvested from the palate in an epithelialized form
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Dentistry faculty of Tehran university of medical sciences
Full name of responsible person
Amine Beymouri
Street address
North Karegar street, Dentistry faculty of Tehran university of medical sciences
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 4279 4000
Email
dentistry@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ahmad Reza Shamshiri
Street address
North Karegar Street, Dentistry faculty of Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 4279 4000
Fax
Email
dentistry@tums.ac.ir
Web page address
http://dentistry@tums.ac.ir
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
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
Tehran University of Medical Sciences
Full name of responsible person
Amine Beymouri
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
North Karegar Street, Dentistry faculty of Tehran university of medical sciences
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 4279 4000
Email
aminebeymouri@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Amine Beymouri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
North Karegar Street, Dentistry faculty of Tehran university of medical sciences
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 4279 4000
Email
aminebeymouri@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Amine Beymouri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
North Kargar street, Dentistry faculty of Tehran university of medical sciences
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 4279 4000
Email
aminebeymouri@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