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IRCT20250309065005N1 IRCT 2025-06-08 Gorgan University of Medical Sciences Evaluation of the effect of oral exercises on salivary flow rate in elderly Evaluation the effect of performing oral exercises on unstimulated salivary flow rate in elderly: A Randomized Clinical Trial 2025-06-21 anticipated 60 Complete https://irct.ir/trial/82595 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: To ensure the uniform distribution of the two variables “smoking status” and “drug use” across the intervention and control groups, stratified randomization was performed as follows: Four strata were first defined by combining the variables: Smoker + drug user Smoker + non-drug user Non-smoker + drug user Non-smoker + non-drug user Within each stratum, the rand function in Excel was used to generate random sequences. To maintain balance, participant allocation was conducted in blocks of four, each block contained two participants assigned to the intervention group (code 1) and two to the control group (code 0). Final random sequences for each stratum were separately generated and stored in numbered, sealed envelopes to ensure allocation remained blinded to researchers until the time of assignment. N/A Dry Mouth. Intervention 1: Intervention group: Oral exercises include exercises for the tongue, facial muscles, salivary glands, and swallowing. The patient is advised to perform oral exercises twice a day, in the morning and evening.1. Facial Muscle Exercises: 1.1 Take a deep breath – while closing your eyes tightly, pull your lips to both sides of your face. 1.2 Open your eyes and mouth completely. 1.3 Close your mouth tightly – fill your cheeks with air – move the air in your cheeks to the right and left. After each set of exercises (1-3), rest your face for approximately 10 seconds. Repeat exercises (1-3) three times. 2. Tongue Exercises: 2.1 Fully extend your tongue, then retract it. 2.2 Extend your tongue and move it to the right and left. 2.3 Lick around your mouth with your tongue. 2.4 Fully extend your tongue, move it up and down to lick your nose and chin. 2.5 Press your upper lip with your tongue. 2.6 Press your lower lip with your tongue. 2.7 Alternately press your right and left cheeks with your tongue. Repeat each of exercises (1-7) approximately five times.3. Exercises for Salivary Glands: 3.1 Parotid Glands: Place four fingers (index finger to little finger) on your cheeks and rotate the area of the upper molars from back to front (10 times). 3.2 Sublingual Glands: Gently press the tongue upwards from under the chin with the thumbs of both hands (10 times). 3.3 Submandibular Glands: Press the soft inner part of the jaw with your thumbs and press from under the ear to the tip of the chin in 4-5 areas (5 times).4. Exercises for Swallowing: 4.1 Neck: Move your neck to the left and right (5 times). 4.2 Shoulders: Raise your shoulders and shorten your neck, then relax (10 times). 4.3 Swallowing: Hold your breath and swallow your saliva (3 times). 4.4 Speech: While keeping your mouth open, loudly pronounce "pa," "ta," "ka," "ra" (3 times). Intervention 2: Control group: No intervention is performed in the control group. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Esra Baghdadi
Villa 13th , Villashahr , Gorgan
Gorgan Iran (Islamic Republic of) 4913887579 009817326228052 Esra.baghdadi@yahoo.comd Gorgan University of Medical Sciences scientific Nazanin Mortazavi
Dental Research Center, Gorgan Dental College ,Shahriyar fifth ,Shahriar County, Gorgan , Golestan
Gorgan Iran (Islamic Republic of) 4938134820 +98 17 3450 2115 mortazavi_nazanin@yahoo.com Gorgan University of Medical Sciences Iran (Islamic Republic of) Elderly people over 60 years of age of both sexes Non-stimulated salivary flow rate of less than or equal to 0.1 ml/min by the Draining method The individual's ability to cooperate in performing exercises 60 years no limit Both (Inability of a person to perform physical exercises (Parkinson's disease, mental disorders such as dementia) Neck trauma History of radiotherapy Mouth breathing habit Hearing, vision, and speech problems (Disorders in saliva secretion in certain diseases (such as Alzheimer's, multiple sclerosis, and Sjögren's syndrome) R68.2 Dry mouth, unspecified Rehabilitation Rehabilitation Intervention group: Oral exercises include exercises for the tongue, facial muscles, salivary glands, and swallowing. The patient is advised to perform oral exercises twice a day, in the morning and evening.1. Facial Muscle Exercises: 1.1 Take a deep breath – while closing your eyes tightly, pull your lips to both sides of your face. 1.2 Open your eyes and mouth completely. 1.3 Close your mouth tightly – fill your cheeks with air – move the air in your cheeks to the right and left. After each set of exercises (1-3), rest your face for approximately 10 seconds. Repeat exercises (1-3) three times. 2. Tongue Exercises: 2.1 Fully extend your tongue, then retract it. 2.2 Extend your tongue and move it to the right and left. 2.3 Lick around your mouth with your tongue. 2.4 Fully extend your tongue, move it up and down to lick your nose and chin. 2.5 Press your upper lip with your tongue. 2.6 Press your lower lip with your tongue. 2.7 Alternately press your right and left cheeks with your tongue. Repeat each of exercises (1-7) approximately five times.3. Exercises for Salivary Glands: 3.1 Parotid Glands: Place four fingers (index finger to little finger) on your cheeks and rotate the area of the upper molars from back to front (10 times). 3.2 Sublingual Glands: Gently press the tongue upwards from under the chin with the thumbs of both hands (10 times). 3.3 Submandibular Glands: Press the soft inner part of the jaw with your thumbs and press from under the ear to the tip of the chin in 4-5 areas (5 times).4. Exercises for Swallowing: 4.1 Neck: Move your neck to the left and right (5 times). 4.2 Shoulders: Raise your shoulders and shorten your neck, then relax (10 times). 4.3 Swallowing: Hold your breath and swallow your saliva (3 times). 4.4 Speech: While keeping your mouth open, loudly pronounce "pa," "ta," "ka," "ra" (3 times). Control group: No intervention is performed in the control group. Unstimulated salivary flow rate. Timepoint: Baseline 4 weeks and 8 weeks later. Method of measurement: Graduated tube , Cotton roll, Digital Scale. Severity of dry mouth. Timepoint: At the beginning of the study, 4 weeks, 8 weeks later. Method of measurement: Xerostomia Inventory questionnaire. Salivary pH. Timepoint: At the beginning of the study, 4 weeks, 8 weeks later. Method of measurement: Graduated tube, pH meter. Gorgan University of Medical Sciences Approved 2025-02-01 Ethics Committee of Gorgan University of Medical Sciences Golestan University of Medical Sciences, Shastcolla street, Gorgan Gorgan Golestan Iran (Islamic Republic of)