Protocol summary

Study aim
Determine the dimensional changes of soft tissue around the implant following free gingival graft and palatal pedicle graft.
Design
Randomized clinical trial, Parallel group, Triple blind, sealed envelope randomization.
Settings and conduct
Tehran dental school, triple blind, palatal pedicle and free gingival graft.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1.Patients aging over 18. 2.Patients Should be healthy (no periodontal and systemic problem.) 3.Patients should have stable implants. 4.Patients should have adequate thickness of palate (2mm) for harvesting. 5.Patients with keratinized tissue width deficiency around implant. Exclusion criteria: 1.Patient with history of radiotherapy and periodontitis. 2.Pregnant and patients smoking more than 10 cigarette each day. 3.Using any drugs which affects periodontal tissue or wound healing. 4.Patients with a history of soft tissue management in desired area.
Intervention groups
Intervention group: In this group, the graft is harvested from the palate adjacent to the implant area and fixed in the vicinity of the implant. Control Group: In this group, the free gingival graft is harvested from the palate and fixed in the vicinity of the implant.
Main outcome variables
Surface Shrinkage Keratinzed tissue width Vestibular Depth

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221226056930N1
Registration date: 2023-03-18, 1401/12/27
Registration timing: registered_while_recruiting

Last update: 2023-03-18, 1401/12/27
Update count: 0
Registration date
2023-03-18, 1401/12/27
Registrant information
Name
Hossein Khoshkhou Titkanlou
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4722 9054
Email address
burntgeneration74@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-20, 1401/12/01
Expected recruitment end date
2023-04-18, 1402/01/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Free Gingival Graft and Palatal Pedicle Graft Technique in peri-implant soft tissue phenotype modification in patients with implants in upper jaw
Public title
Evaluation of two techniques of free gingival graft and palatal pedicle graft in soft tissue around the implant.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1patinets age over 18 years old. 2.Healthy in systemic and periodontal condition. 3.patients with stable implants 4. patients with adequate thickness of palate for graft harvesting. 5.patients with keratinized tissue width deficiency.
Exclusion criteria:
patients with history of radiotherapy or periodontitis.2. pregnant women or patients with a history more than 10-cigarrete smoking per day.3.patients who are undertreatment of drugs affecting periodontal tissue and wound healing.4.patients with a history of soft tissue grafting in site of surgery
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 34
Randomization (investigator's opinion)
Randomized
Randomization description
Individual randomization; Sealed envelope; The name of the surgical procedure is written on a sealed envelope and then on the day of surgery one of the envelopes is opened and the surgery is performed accordingly. Participants ,researchers and Data Safety Monitoring Board personals were blind to the study.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The participants were blinded by the knowledge that they were participating in a research study, and the researcher and statistical analyzer are blind to the type of surgical technique performed for each patient.
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
Room6202, Enqelab Dormitory, Martyr Borhani alley, Martyr Hamidreza Hosseinalipour alley, Enqelab square, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1417933486
Approval date
2022-08-24, 1401/06/02
Ethics committee reference number
IR.TUMS.DENTISTRY.REC.1401.079

Health conditions studied

1

Description of health condition studied
Comparison of free gingival graft and palatal pedicle graft
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Keratinized tissue width
Timepoint
Before intervention, 1month, 3month.
Method of measurement
University of North California-15 probe.

Secondary outcomes

1

Description
Soft tissue surface shrinkage around implant.
Timepoint
Before intervention, 1month after intervention, 3months after intervention.
Method of measurement
Image j software.

2

Description
Vestibular depth changes.
Timepoint
Before intervention, 1month after intervention, 3months after intervention.
Method of measurement
University of North California-15 probe.

3

Description
Numeric analogue scale.
Timepoint
Before intervention,1month after intervention, 3months after intervention.
Method of measurement
Likert scale.

4

Description
Amount of the analgesic pill used.
Timepoint
Before intervention,1month after intervention, 3months after intervention.
Method of measurement
Note in the postoperative form provided to the patient.

Intervention groups

1

Description
Intervention group: Palatal pedicle graft.
Category
Treatment - Surgery

2

Description
Control group: Free gingival graft.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Dental school, Tehran university of medical sciences.
Full name of responsible person
Hossein Khoshkhou Titkanlou
Street address
Room6202, Enqelab Dormitory, Martyr Borhani alley, Martyr Hamidreza Hosseinalipour alley, Enqelab square, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1417933486
Phone
+98 915 219 8011
Email
burntgeneration74@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
حسین خوشخو تیتکانلو
Street address
Room6202, Enqelab Dormitory, Martyr Borhani alley, Martyr Hamidreza Hosseinalipour alley, Enqelab square, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1417933486
Phone
+98 915 219 8011
Email
burntgeneration74@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
Hossein Khoshkhou Titkanlou
Position
Resident
Latest degree
Subspecialist
Other areas of specialty/work
Dentistry
Street address
Room6202, Enqelab Dormitory, Martyr Borhani alley, Martyr Hamidreza Hosseinalipour alley, Enqelab square, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1417933486
Phone
+98 915 219 8011
Email
burntgeneration74@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hossein Khoshkhou Titkanlou
Position
Resident
Latest degree
Subspecialist
Other areas of specialty/work
Dentistry
Street address
Room6202, Enqelab dormitory, Martyr Borhani alley, North Kargar street, Enqelab square, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1417933486
Phone
+98 915 219 8011
Email
burntgeneration74@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hossein Khoshkhou Titkanlou
Position
Resident
Latest degree
Subspecialist
Other areas of specialty/work
Dentistry
Street address
Room6202, Enqelab dormitory, Martyr Borhani alley, North Kargar street, Enqelab square, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1417933486
Phone
+98 915 219 8011
Email
burntgeneration74@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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