Evaluation of the effect of 0/3% Pilocarpine mouthwash on xerostomia in diabetic patients with xerostomia

Evaluation of the effect of 0/3 percent Pilocarpine mouthwash on xerostomia in diabetic patients with xerostomia, presented to Kerman Shahid Bahonar hospital diabetes center in year 1402

Clinical trial with control group, triple blinded, crossover groups, phase 3 on 80 patients. Randomized by simple randomization method by the way of shuffling 80 similar cards 40 marked with code A and 40 with B.

Sampling is done by convenience method. Researchers attend the diabetes center and explain the conditions of the project. If the inclusion criteria exists, people will be included after obtaining written informed consent. The sample is divided into intervention and control groups with randomization and desired variables will be checked and recorded. For blinding, 80 medicated and 80 placebo mouthwashes with similar appearance will be coded with arbitrary codes A and B, by a person (employee of the Oral Diseases Department of Kerman Dental School) who doesn't benefit from the study. All patients, clinical caregivers, researchers, outcome assessors and data analysts will be blinded to the codes related to mouthwashes.

The sample consists of 80 over 18-year-old patients referred to Diabetes Center of Kerman Bahonar Hospital. The inclusion criteria are diabetes mellitus (according to the American Diabetes Association), dry mouth (according to the Fox questionnaire), willingness and ability to cooperate correctly. History of uncontrolled asthma, gastric ulcer, autoimmune disease, use of drugs affecting the amount of saliva and dry mouth, HIV, hepatitis B and C infections and unwillingness to cooperate are criteria for not entering.

Intervention group receives 0.3% pilocarpine mouthwash and control group receives placebo mouthwash.

Severity of xerostomia ; volume of unstimulated saliva

Randomization is done by simple randomization method. The desired method is done by punching 80 cards with the same appearance, which contain the necessary information to cooperate in the project along with the code related to the group of participants. According to the design of the study, 40 of the cards are coded as A and the other 40 are coded as B. In order to hide the random allocation, the cards are placed in the same opaque sealed envelopes, and after determining the group of each participant, the opened envelope is removed from the sequence. At the time of registration of eligible study participants and after obtaining informed consent, one of the envelopes is allocated to each person, which determines the participant's group. The sequence of random cards and the sealing of card envelopes are done by the researcher Mr. Mohammad Shayan Shakri, and in order to reduce the possible distortions caused by the knowledge of the researchers about the intervention groups, all researchers are blinded. Due to the cross-over design of the study, the randomization sequence was determined only for the initiation treatment.

At the beginning of the study, 80 pieces of drug mouthwash (pilocarpine) and 80 pieces of placebo mouthwash that were prepared in the same color with the same taste and smell in the same packaging and volume were prepared in two separate groups to one person (from the employees of the oral diseases department of the Kerman Faculty of Dentistry) ), which is without profit and knowledge of the conditions and results of the study, is delivered, which are coded by them with arbitrary codes A and B. Allocation of mouthwash to the participants is done by randomization according to the mentioned method and based on the study design. All participating patients, clinical caregivers, researchers, outcome assessors and data analysts will not know the type of mouthwash used by people (medicinal or placebo) and the code related to the type of mouthwash. After the implementation and completion of the study and analysis of the results, the knowledgeable person responsible for coding the mouthwashes reveals the type of mouthwash corresponding to each code.