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IRCT201201278830N1 IRCT 2016-10-22 Research Affairs, Tehran University of Medical Science Effects of erythropoietin in palatal wound healing, Effect of Erythropoietin on healing of gingival graft 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. 2016-10-22 anticipated 24 Complete https://irct.ir/trial/9316 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: 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, Blinding description: 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. 1-2 palatal wound. Intervention 1: 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). Intervention 2: 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). No - There is not a plan to make this available Justification or reason for not sharing IPD is According to the routine process of publications, the data will be presented to the journal if required or every researcher who asks for.
public Siamak Yaghobee
North Amirabad 14399-55991
Tehran Iran (Islamic Republic of) 1439955991 +98 21 8835 1168 ninarouzmeh@yahoo.com Tehran University of Medical Sciences scientific SeyedehNina Rouzmeh
North Amirabad Street, Post code: 14399-55991, Tehran, Iran,
Tehran Iran (Islamic Republic of) ۱۴۳۹۹۵۵۹۹۱ +98 21 8835 1168 ninarouzmeh@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) 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 18 years no limit Both Treatment - Drugs Treatment - Drugs 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). 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). Epithelialization. Timepoint: on days 7, 14 , 21 and 28. Method of measurement: Hydrogen Peroxide 3% application. Degree of healing. Timepoint: on days 7, 14,21,28, 60, 90. Method of measurement: Graft color match, contour, and texture. Inflammation on recipient site. Timepoint: on days 7, 14,21,28, 60, 90. Method of measurement: based on the size of the red inflammatory halo around the graft. Inflammation. Timepoint: on days 7,14,21 and 28. Method of measurement: direct observation of the region, also photographs taken from test and control areas are prepared to be observed by three periodontists. Research Affairs, Tehran University of Medical Science Approved 2014-11-23 Ethics committe of Tehran University of Medical Science North Karegar Street Tehran Tehran Iran (Islamic Republic of)