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IRCT20160731029133N5 IRCT 2018-01-30 Zanjan University of Medical Sciences Evaluation the effect of complementary treatment with pistacia atlantica mouthwash on chemotherapy-induced mucositis Evaluation the effect of complementary treatment with pistacia atlantica mouthwash on chemotherapy-induced mucositis (a double blind randomized placebo controlled clinical trial) 2018-01-04 anticipated 30 Complete https://irct.ir/trial/23502 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: All the members of both groups have to use MAGIC mouthwash as the basic treatment.This mouthwash consists of: Aluminum-magnesium suspension 200 ml,Diphenhydramine Syrup 50 ml,One Lidocaine carpule,One Dexamethasone ampule,and a bottle of Nystatine.All the members of both groups have to gargle 10 ml of this mouthwash 30 seconds,3 times a day for 7 days, Randomization description: We use Block Randomization with individual units in this study and we use sealed envelopes as randomization tool, Blinding description: This is a double blind study.actually the researcher and the participates aren't aware of the grouping randomization process.In order to blind the researcher,instead of the researcher,one of the hospital doctors will put each participate into one of two groups randomly; and in order to blind participates we try to make the mouthwash and the placebo taste the same and prescribe in similar bottles. 2-3 Condition 1: chemotherapy-induced mucositis. Condition 2: Xerostomia. Intervention 1: The members of the experimental group have to use Pistacia Atlantica mouthwash in addition to that basic treatment.This mouthwsh consists of: Humectant 5-20%(Glycerine-Sorbitol- propylene glycol),Surfactant 5%(Tween80 and sodium lauryl sulfate),a small am. Intervention 2: The members of the control group have to use placebo in addition to basic treatment,to eliminate mental effects.(However they shoudn't know that this mouthwash is just a placebo.) Placebo consists of flavoring agents and water.the members of the control . Yes - There is a plan to make this available What will be shared: All datas will be published after blinding When: 2 m after publishing the results To whom: researchers working in scientific centers Conditions: datas can be use for furture analysis Where to obtain: zanjan dental school How to obtain: 1- written request ti research center 2- evaluation in reasearch councile. 3- 1 month Comments:
public Dr. Neda Gholami
Zanjan Faculty of Dentistry, Shahrak Karmandan
Zanjan Iran (Islamic Republic of) 4513956112 +98 24 3347 1118 dr.gholami.n@zums.ac.ir Zanjan University of Medical Sciences scientific Dr. Neda Gholami
Zanjan Faculty of Dentistry, Shahrak Karmandan
Zanjan Iran (Islamic Republic of) 4513956112 +98 24 3347 1118 dr.gholami.n@zums.ac.ir Zanjan University of Medical Sciences Iran (Islamic Republic of) 1-Existence of chemotherapy-induced mucositis. 2-Participates must be at least 18 years old. 3-Not existence of serious dental problems or traumatic teeth or sharp-pointed cusps or fillings. 4-Not using of traumatic dentures. 5-Not using of anti-inflammatory agents or other mouthwashes during the study. 6-Absence of other systemic disease 18 years no limit Both 1-Patients' inability to do the instructions of the protocol of the study. 2-Patients' death because of not responding to the cancer treatment. 3-Complementary treatments such as radiotherapy. 4-The history of allergy to pistacia atlantica. 5-The history of usage of cigarette,narcotics and alcohol. K12.3 K11.7 Oral mucositis (ulcerative) Disturbances of salivary secretion Treatment - Drugs Placebo The members of the experimental group have to use Pistacia Atlantica mouthwash in addition to that basic treatment.This mouthwsh consists of: Humectant 5-20%(Glycerine-Sorbitol- propylene glycol),Surfactant 5%(Tween80 and sodium lauryl sulfate),a small am The members of the control group have to use placebo in addition to basic treatment,to eliminate mental effects.(However they shoudn't know that this mouthwash is just a placebo.) Placebo consists of flavoring agents and water.the members of the control Severity of oral mucositis. Timepoint: Before intervention, 3 days after beginning of the intervention, 7 days after beginning of the intervention(the last day of the intervention). Method of measurement: WHO scoring system. Severity of xerostomia. Timepoint: Before intervention, 3 days after beginning of the intervention, 7 days after beginning of the intervention(the last day of the intervention). Method of measurement: Lickert's method. Zanjan University of Medical Sciences Approved 2017-08-22 Ethics committee of Zanjan University of Medical Sciences Zanjan University of Medical Sciences, Azadi Square Zanjan Zanjan Iran (Islamic Republic of)