History
# Registration date Revision Id
2 2025-03-27, 1404/01/07 334874
1 2023-12-12, 1402/09/21 288250
Changes made to previous revision
This is the first revision

Protocol summary

Study aim
Determination of the success rate of free gingival graft treatment in increasing keratinized gingival width and vestibule depth with and without using periodontal dressing
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 26 patients. Randomization is done in a simple and individual way, and a table of random numbers is used for randomization.
Settings and conduct
The study is in the field of improving the quality of gingival tissue. Gingival transplant surgery will be performed for patients without sufficient keratinized gingiva in two groups, with and without using periodontal dressings, at Tehran Faculty of Dentistry. The researcher and the analyst are blinded to the study groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: people who have placed at least two implants at the posterior of the mandible due to partial edentulousness (as the most posterior teeth); Patient who have insufficient vestibular depth in this place. Exclusion criteria: systemic disease that interferes with wound healing; alcohol and drug abuse; smoking; uncontrolled periodontal disease; pregnant and lactating mothers; patients with parafunctional habits.
Intervention groups
Intervention group: Free gingival graft surgery is performed in the edentulous area posterior of the mandible. The graft is harvested from the palate area. Finally, it is fixed in the intended place with stitches. Then, in patients, periodontal dressing is used in the place of fixation. Control group: Free gingival graft surgery is performed in the edentulous area posterior of the mandible. The graft is harvested from the palate and fixed in the desired place with sutures.
Main outcome variables
The depth of the vestibule; Keratinized gingiva.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231115060072N1
Registration date: 2023-12-12, 1402/09/21
Registration timing: prospective

Last update: 2023-12-12, 1402/09/21
Update count: 1
Registration date
2023-12-12, 1402/09/21
Registrant information
Name
Amirmohammad Dolatabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4279 4000
Email address
a_dolatabadi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-08, 1403/01/20
Expected recruitment end date
2024-10-11, 1403/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the success rate of free gingival graft treatment with and without using periodontal dressing in increasing keratinized gingival width and vestibule depth: a randomized clinical trial
Public title
The success rate of gum grafting with and without dressing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People who have placed at least two implants at the posterior of mandible due to partial edentulousness (as the most posterior teeth). Patients who have insufficient vestibular depth at the implants placement site.
Exclusion criteria:
Systemic disease that interferes with wound healing. Alcohol and drug abuse Cigarette smoking Uncontrolled periodontal disease Pregnant and lactating mothers Patients with parafunctional habits
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 26
Randomization (investigator's opinion)
Randomized
Randomization description
Simple and individual randomization; People who meet the entry criteria are assigned a number and enter the study. Then, each number representing the patient is placed in one of the 2 intervention and control groups by the random number table. Sealed envelope method will be used for allocation concealment. Determining the placement of the dressing is written in the envelope for each patient, then on the day of the surgery, and at the end of that, the envelope for the patient is opened, and based on that, the dressing is placed or not at the surgery site.
Blinding (investigator's opinion)
Double blinded
Blinding description
The researcher and the statistical analyst are blinded to the type of surgical technique performed in each patient. The data in two groups A and B will be given to the analyzer without mentioning whether each group is a test or a control. There is no possibility of blinding the patients due to the observation of the dressing in the mouth. Also, until the end of the surgery and the placement of the dressing, the surgeon is unaware of which group the patient is in, so that the surgical procedure does not differ between the groups.
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
At the end of North Kargar St., not reaching Hakim Highway, Faculty of Dentistry
City
Tehran
Province
Tehran
Postal code
1439955991
Approval date
2023-11-15, 1402/08/24
Ethics committee reference number
IR.TUMS.DENTISTRY.REC.1402.081

Health conditions studied

1

Description of health condition studied
Gingival transplant surgery technique
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Vestibular depth
Timepoint
At the beginning of the study, 1 month after surgery, 3 months after surgery
Method of measurement
Intraoral scanner

2

Description
Keratinized gingiva
Timepoint
At the beginning of the study, 1 month after surgery, 3 months after surgery
Method of measurement
Periodontal probe

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:Free gingival graft surgery is performed in the edentulous area posterior of the mandible. The graft is harvested from the palate. Finally, it is fixed in the intended place with stitches. Then, in patients, periodontal dressing is used in the fixation place.
Category
Treatment - Surgery

2

Description
Control group: Free gingival graft surgery is performed in the edentulous area posterior of the mandible. After preparing the recipient bed, the graft is harvested from the palate. Finally, the grafted tissue is fixed in the intended place with sutures.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Faculty of Dentistry, Tehran University of Medical Sciences
Full name of responsible person
Amirmohammad Dolatabadi
Street address
At the end of North Kargar St., not reaching Hakim Highway, Faculty of Dentistry
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 910 260 3606
Email
armd.dolatabadi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Amirmohammad Dolatabadi
Street address
At the end of North Kargar St., not reaching Hakim Highway, Faculty of Dentistry
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 910 260 3606
Email
armd.dolatabadi@gmail.com
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
Amirmohammad Dolatabadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No. 31, Safavyan Alley, Sattar Khan Street, Tehran
City
Tehran
Province
Tehran
Postal code
1444783911
Phone
+98 21 6656 0137
Email
armd.dolatabadi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Amirmohammad Dolatabadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No. 31, Safavyan Alley, Sattar Khan Street, Tehran
City
Tehran
Province
Tehran
Postal code
1444783911
Phone
+98 21 6656 0137
Email
armd.dolatabadi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Amirmohammad Dolatabadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No. 31, Safavyan Alley, Sattar Khan Street, Tehran
City
Tehran
Province
Tehran
Postal code
1444783911
Phone
+98 21 6656 0137
Email
armd.dolatabadi@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
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