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IRCT20210510051255N1 IRCT 2021-07-05 Ghoum University of Medical Sciences Comparing the Effect of Short-Term Use of Vitamin D with Vitamin D Plus Calcium Supplement in Treatment of Patients with Periodontitis Referred to Qom Dental School from 2021 to 2022 Comparing the Effect of Short-Term Use of Vitamin D with Vitamin D Plus Calcium Supplement in Treatment of Patients with Periodontitis Referred to Qom Dental School from 2021 to 2022 2021-06-22 anticipated 51 Complete https://irct.ir/trial/56207 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Assigning patients to three groups receiving vitamin D and SRP, vitamin D and calcium, and SRP and SRP alone.It will be done by blocking method and using 6 blocks. Patients are divided into three groups using a randomized balanced block method with a block size of 6. A random sequence is created by an epidemiologist by running an online application on the website (https://www.sealedenvelope.com). 2-3 Condition 1: Periodontitis. Condition 2: Vitamin D deficiency. Intervention 1: The first Intervention group: Scaling & Root Planning of the whole mouth and then hygiene training is done similarly by flossing and brushing with the modified Bass method. After two weeks of SRP, Prescribe 50,000 IU of vitamin D weekly and 1,000 mg of calcium supplement daily. Intervention 2: The second intervention group: Scaling & Root Planning of the whole mouth and then hygiene training is done similarly by flossing and brushing with the modified Bass method. After two weeks of SRP, Prescribe 50,000 IU of vitamin D weekly. Intervention 3: Control group: Scaling & Root Planning of the whole mouth and then hygiene training is done similarly by flossing and brushing with the modified Bass method. No medication is prescribed for this group as a control group. Yes - There is a plan to make this available What will be shared: All data can potentially be shared after unidentified individuals When: access the data 6month after the result are published To whom: The data will be available only to researchers working in academic and scientific institutions Conditions: People working on patients with periodontitis or vitamin D deficiency Where to obtain: Applicants can apply via the following e-mail to receive the required documents or data dentistryabedini74@gmail.com How to obtain: Email to the project presenter-Request from the Vice Chancellor for Research-If positive, provide information to the applicant Comments:
public Fateme Abedini
Qom Dental School, Shahid Lavasani St.
Qom Iran (Islamic Republic of) 39367-37136 +98 25 3770 3738 dentistryabedini74@gmail.com Ghoum University of Medical Sciences scientific Dr. Leila Khodadadifard
Qom Dental School, Lavasani St.
Qom Iran (Islamic Republic of) 3713649373 +98 25 3770 0095 l.khodadadifard@gmail.com Ghoum University of Medical Sciences Iran (Islamic Republic of) People with an average age of 20 to 70 years old They have more than 20 teeth left in his mouth At least two interproximal areas with CAL (clinical attachment level) more than 3 mm. 20 years 70 years Both People with systemic problems such as diabetes, hypothyroidism or hyperthyroidism and any endocrine-related diseases Severe systemic diseases such as cancer Consumption of vitamin D and calcium during the three months before the study Pregnancy and lactation People who have received non-surgical periodontal treatment or periodontal surgery in the past year Use of antibiotics and immunosuppressive drugs that affect the metabolism of vitamin D and calcium K05.32 E55 Chronic periodontitis, generalized Vitamin D deficiency Treatment - Drugs Treatment - Drugs Treatment - Other The first Intervention group: Scaling & Root Planning of the whole mouth and then hygiene training is done similarly by flossing and brushing with the modified Bass method. After two weeks of SRP, Prescribe 50,000 IU of vitamin D weekly and 1,000 mg of calcium supplement daily. The second intervention group: Scaling & Root Planning of the whole mouth and then hygiene training is done similarly by flossing and brushing with the modified Bass method. After two weeks of SRP, Prescribe 50,000 IU of vitamin D weekly. Control group: Scaling & Root Planning of the whole mouth and then hygiene training is done similarly by flossing and brushing with the modified Bass method. No medication is prescribed for this group as a control group Probing depth. Timepoint: Baseline, three months later. Method of measurement: Periodontal probe. Clinical attachment loss. Timepoint: Baseline, three months later. Method of measurement: Periodontal probe. Bleeding on probing. Timepoint: Baseline, three months later. Method of measurement: Periodontal probe. Plaque index. Timepoint: Baseline, three months later. Method of measurement: Determination of plaque score according to O’Leary method. Gingival index. Timepoint: Baseline, three months later. Method of measurement: Observation. 25-hydroxyvitamin D. Timepoint: During the study. Method of measurement: Venous blood sampling. Ghoum University of Medical Sciences Approved 2021-05-02 Ethics committee of Qom University of Medical Sciences No. 83, Jihad Daneshgahi Alley, Shahid Lotfi Niasar (Alley No. 4), Safashahr St. Qom Ghoum Iran (Islamic Republic of)