Protocol summary

Study aim
Evaluation the effect of the bromelain Gel on wound healing after free gingival graft
Design
Two arm parallel group randomized trial with double-blind postoperative care, outcome assessment and participants. Phase 3 on 28 patients. Block method will be used for randomization.
Settings and conduct
A study on the healing of palatal wound after free gingival grafting will be conducted on patients with keratinized gingival width deficiency who are candidates for gingival grafting in Tehran Faculty of Dentistry with two groups with and without the use of bromelain gel. Participants and analyzers Statistics of the type of surgical technique performed in each patient are blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients over 18 years old who need free gingival grafting treatment around teeth or implants, systemically healthy, non-smokers, measuring 10 mm wide and 15 to 20 mm long. Exclusion criteria: presence of periodontal disease, systemic diseases that are contraindications to periodontal surgeries or interfere with tissue repair, pregnancy and breastfeeding.
Intervention groups
Control group: for patients in this group, no bromelain gel will be placed on the wound site after surgery, and only the periodontal pack will be placed on the palatal wound area. Intervention group: 1% bromelain gel is placed in the palatal wound area of these patients after surgery, and after applying the gel, a periodontal pack is placed in the palatal wound area.
Main outcome variables
The average area of the remaining wound in the palate area, the amount of bleeding , the amount of color adaptation, the amount of epithelialization, pain and discomfort, Lundry's healing index

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231118060098N1
Registration date: 2024-01-12, 1402/10/22
Registration timing: prospective

Last update: 2024-01-12, 1402/10/22
Update count: 0
Registration date
2024-01-12, 1402/10/22
Registrant information
Name
Fateme Godarzi Moghadam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4279 4000
Email address
f-goodarzim@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-10, 1402/12/20
Expected recruitment end date
2024-09-10, 1403/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating The Effect Of Bromelain Gel Added To Periodontal Pack Compared To Periodontal Pack Alone On The Healing Of Palatal Wound Resulting From Harvesting The Free Gingival Graft On Patients With Keratinized Gingival Width Deficiency Who Are Candidates For Gingival Grafting; A Parallel Clinical Trial Study
Public title
The effect of pineapple gel on palatal wound healing after gingival graft
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients over 18 years old The need for free gingival graft around the tooth or implant Systemically healthy Non-smokers Graft dimensions 10 mm wide and 15 to 20 mm long
Exclusion criteria:
Active gag reflex Presence of periodontal disease Lack of sensation Mobility and occlusal trauma Missing canine teeth up to maxillary first molar Additional forces including mechanical forces from orthodontics and traumatic occlusion Systemic diseases that are contraindications for periodontal surgeries or have interactions by tissue repair Pregnancy and breastfeeding
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 28
Randomization (investigator's opinion)
Randomized
Randomization description
The samples are randomly divided into two groups using balance block randomization (size = 4). For this purpose, the allocation method in each of the blocks is determined using Excel software in such a way that at least 2 samples of any intervention are in each block. The randomization process is carried out by the study methodology consultant. The type of allocation after randomization is noted in the envelope with numbers 1 to 28 for each sample. When conducting the study, the operator opens the envelopes in order and aware of the type of sample's allocation at the time of intervention.
Blinding (investigator's opinion)
Double blinded
Blinding description
People entered in the study, knowing that they are participating in a research study, are blinded to the allocation to the desired treatment group, and the statistical analyzer is blinded to the type of surgical technique performed in each patient. Both groups receive periodontal packs with the same color, taste and shape, so the patient does not know the presence or absence of gel under the pack.
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
Dental school; not reaching Hakim highway; At the end of North Kargar street
City
Tehran
Province
Tehran
Postal code
1439955991
Approval date
2023-10-21, 1402/07/29
Ethics committee reference number
IR.TUMS.DENTISTRY.REC.1402.069

Health conditions studied

1

Description of health condition studied
Palate wound
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The average area of the remaining wound in the palate
Timepoint
Days 7, 14, 21 and 28 after surgery
Method of measurement
Image J computer program to check the area of the remaining wound

2

Description
The amount of bleeding after surgery
Timepoint
The first 3 days after surgery
Method of measurement
Questionnaire and observation

3

Description
The degree of color matching
Timepoint
Days 7, 14, 21 and 28 after surgery
Method of measurement
Adobe Photoshop CS3 computer program to check Brightness parameters

4

Description
The amount of epithelialization
Timepoint
Days 7, 14, 21 and 28 after surgery
Method of measurement
Using 3% H2O2 and observing oxygen bubbles

5

Description
Average index of pain and discomfort
Timepoint
Days 7, 14, 21 and 28 after surgery
Method of measurement
Questionnaire and VAS chart

6

Description
Lundry's healing index next
Timepoint
Days 7, 14, 21 and 28 after surgery
Method of measurement
Direct touch and examination by a specialist

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In this study free gingival graft surgery is performed by removing the graft from the palate area, 1% bromelain gel, a polymer gel made from mixing biocompatible polymer and water (at high temperature) and a microbial protector that is allowed to be used in the mouth (to prevent microbial contamination), with the active ingredient of the study that It is bromelain powder. After surgery, 1% bromelain gel is placed on the wound area for patients in this group, and after applying the gel, a periodontal pack is placed on the palatal wound area. The gel is applied on the area on the day of surgery and two days later.
Category
Treatment - Drugs

2

Description
Control group: Free gingival graft surgery is performed by removing the graft from the palate area. After the surgery, no gel is placed on the wound area of the patients in this group, and only periodontal pack is placed on the area of the palate wound.
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
Fateme Godarzi Moghadam
Street address
Dental school; not reaching Hakim highway; At the end of North Kargar street
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8670 5503
Email
fateme.godarzii1998@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Akbari Sari
Street address
Dental school; not reaching Hakim highway; At the end of North Kargar street
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 4279 4000
Email
fateme.godarzii1998@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
Fateme Godarzi Moghadam
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Dental school; not reaching Hakim highway; At the end of North Kargar street
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 4279 4000
Email
fateme.godarzii1998@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fateme Godarzi Moghadam
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Dental school; not reaching Hakim highway; At the end of North Kargar street
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 4279 4000
Email
fateme.godarzii1998@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fateme Godarzi Moghadam
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Dental school; not reaching Hakim highway; At the end of North Kargar street
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 4279 4000
Email
fateme.godarzii1998@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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