Protocol summary
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Study aim
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Evaluating the effect of local Erythropoietin(EPO) on palatal wound epithelialization and healing and inflammation in free gingival graft(FGG) recipient site
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Design
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This is a split-mouth randomized controlled clinical trial on seventeen patients who need FGG for at least two sites in mandible. The patient, the surgeon, the initial and final examiner, and the data analyzer are blinded to the intervention.
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Settings and conduct
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A standardized 10*15 mm graft is harvested from premolar and first molar area of the hard palate.
In the donor site: On the day of surgery and 2 days after surgery, on the test site 1ml of the gel containing 4,000 IU ml-1 EPO and on the donor test site, 2ml gel without EPO is applied on the control site.
In the recipient site:
Test sides are treated with 1 ml erythropoietin (EPO) 4000 IU and the control sites receive 1 ml of distilled water. After two minutes, the harvested gingival graft is stabilized with synthetic absorbable 4/0 sutures. both sites are then covered with surgical dressing.
The outcomes are evaluated on days 7,14,21,28,60,90.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria : 1) age of 18 years old or above; 2) periodontal health;
Exclusion criteria: 1) compromised systemic health, such as diabetes mellitus and immune suppression; 2) consumption of anti-inflammatory or antibiotics during last 3 months; 3) smoking, and 4) O’Leary plaque index>15% after phase I periodontal therapy.
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Intervention groups
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Application of Gel with or without EPO on test or control sites of palate.
application of EPO or stilled water on test or control sites before graft suturing.
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Main outcome variables
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epithelialization rate in palate
healing degree in recipient site
inflammation around recipient site
General information
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Reason for update
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In order to add the second part of the same study, with the same protocol and on the same patients.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT201201278830N1
Registration date:
2016-10-22, 1395/08/01
Registration timing:
registered_while_recruiting
Last update:
2021-08-21, 1400/05/30
Update count:
1
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Registration date
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2016-10-22, 1395/08/01
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Vice Chancellor for Research, Tehran University of Medical Sciences
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Expected recruitment start date
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2016-10-22, 1395/08/01
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Expected recruitment end date
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2017-02-19, 1395/12/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The Eeffect of Topical Erythropoietin on Palatal Wound Healing Subsequent to Free Gingival Graft in patients with insufficient keratinized gingiva. Evaluation of Topical Erythropoietin Application on the Healing Outcome of Gingival Graft Recipient Site; A Randomized Controlled Clinical Trial.
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Public title
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Effects of erythropoietin in palatal wound healing, Effect of Erythropoietin on healing of gingival graft
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
age of 18 years old or above
periodontal health;
need for gingival graft in order to augment keratinized gingiva in at least two mandibular areas
Exclusion criteria:
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Age
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From 18 years old
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Gender
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Both
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Phase
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1-2
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Groups that have been masked
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No information
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Sample size
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Target sample size:
24
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Balanced block randomization was used to allocate each patient into one of the following categories:
- Right side surgery first, treated with distilled water on recipient site and gel without EPO on donor site
- Right side surgery first, treated with EPO on recipient site and gel containing EPO on donor site
- Left side surgery first, treated with distilled water on recipient site and gel without EPO on donor site
- Left side surgery first, treated with EPO on recipient site and gel containing EPO on donor site
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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The patient, the surgeon, the initial and final examiner, and the data analyzer are blinded to the intervention. To meet the assumptions of randomization, a number of sealed non-transparent coded envelopes are prepared with letters A, B, C, or D printed on them. A third individual opens each envelope and explains the sequence of surgery and gel application to the surgeon.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2014-11-23, 1393/09/02
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Ethics committee reference number
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9011213001-119225
Health conditions studied
1
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Description of health condition studied
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palatal wound
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Epithelialization
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Timepoint
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on days 7, 14 , 21 and 28
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Method of measurement
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Hydrogen Peroxide 3% application
2
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Description
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Degree of healing
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Timepoint
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on days 7, 14,21,28, 60, 90
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Method of measurement
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Graft color match, contour, and texture
3
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Description
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Inflammation on recipient site
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Timepoint
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on days 7, 14,21,28, 60, 90
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Method of measurement
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based on the size of the red inflammatory halo around the graft
Secondary outcomes
1
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Description
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Inflammation
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Timepoint
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on days 7,14,21 and 28
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Method of measurement
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direct observation of the region, also photographs taken from test and control areas are prepared to be observed by three periodontists
Intervention groups
1
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Description
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Control group:A 10*15 mm template is used to harvest a graft from premolar and first molar area of the hard palate and is fixed in the recipient site.In control site: After bleeding control in the donor site, the day of surgery and 2 days after surgery 1ml of the hydroxy ethyl cellulose without Erythropoietin is applied on the wound site.To prepare the bed, a split thickness horizontal incision at mucogingival junction (15 mm long) and two vertical incisions at both ends (10 mm long) is made with scalpel blade no. 15. The control sides receive 1 ml of distilled water. After two minutes, the harvested gingival graft is adapted on the site and stabilized with synthetic absorbable 4/0 sutures (Polyglycolate coated; SUPABON, SUPA, Iran). Then the wound sites are covered with a foil and the periodontal pack (coe pak, GC America Co., USA).
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Category
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Treatment - Drugs
2
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Description
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Intervention group: A 10*15 mm template is used to harvest a graft from premolar and first molar area of the hard palate and is fixed in the recipient site.After bleeding control in the donor site, the day of surgery and 2 days after surgery 1ml of the hydroxy ethyl cellulose gel containing 4,000 IU ml-1Erythropoietin (pooyesh daroo) is applied on the wound site.Then the wound sites are covered with a foil and the periodontal pack (coe pak, GC America) is placed over them. To prepare the bed, a split thickness horizontal incision at mucogingival junction (15 mm long) and two vertical incisions at both ends (10 mm long) is made with scalpel blade no. 15. Test sides are treated with 1 ml erythropoietin (EPO) 4000 IU ( PDpoetin, Pooyeshdarou, Tehran, Iran) . After two minutes, the harvested gingival graft is adapted on the site and stabilized with synthetic absorbable 4/0 sutures (Polyglycolate coated; SUPABON, SUPA, Iran). Then the wound sites are covered with a foil and the periodontal pack (coe pak, GC America Co., USA).
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Research Affairs, Tehran University of Medical Science
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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According to the routine process of publications, the data will be presented to the journal if required or every researcher who asks for.
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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The first part related to palatal healing has been published.
The part related to recipient site is in submission progress.
Effect of Topical Erythropoietin (EPO) on palatal wound healing subsequent to Free Gingival Grafting (FGG), Siamak Yaghobee 1, Nina Rouzmeh 1, Hoori Aslroosta 1, Sanaz Mahmoodi 2, Afshin Khorsand 1, Mohamad Javad Kharrazifard 3; Braz Oral Res. 2018 Jun 11;32:e55
Data and photographs will be available if requiered.
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When the data will become available and for how long
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Part of it has been published.
The second part will be accessible after publication.
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To whom data/document is available
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Every researcher( working at university or not, related to dentistry or not) who receives the article from journal.
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Under which criteria data/document could be used
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For future studies.
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From where data/document is obtainable
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From the related journal (which is open access) in which the article is published, the article is free and available.
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What processes are involved for a request to access data/document
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Following the rules of the journal in which the article is published. As the first article is published in an open access journal, the article is available at no charge. The second article will be available the same way when published.
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Comments
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