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IRCT20080831001150N6 IRCT 2022-10-16 Goltash company, Paksan Effect of a Persica-containing toothpaste in plaque induced gingivitis Comparative evaluation of the effectiveness of a Persica-containing toothpaste over a Persica-free toothpaste in patients with plaque-induced gingivitis 2022-12-22 anticipated 130 Complete https://irct.ir/trial/65740 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Balanced block randmization: we put people randomly in blocks containing 4 or 6 people. Then half of every block will randomly be in the control and the other half in the intervention Unit of randomization: personal Not using layers of randomization Done by using statical softwares Allocation: files containing the information will be kept with a person who will not be participating or conducting the study, Blinding description: In this study the examiner, analytical counselor, person handing out the toothpastes, patient and the person controlling the study will be blind about which toothpaste is the patient using. 0 (exploratory trials) Plaque induced gingivitis. Intervention 1: Intervention group: On the first appointment after the clinical periodontal examinations, the patient will receive phase one treatment: Root planing and scaling (SRP), and then will be given a Persica-containing toothpaste (Commercially known as Dentamax herbal toothpaste, Goltash company, Isfahan, Iran) to use twice a day, before sleep and after breakfast, each time in the size of a pea and then brush their teeth using the Rolling method. The patient will also be given dental floss to use after brushing their teeth. later on, the patient will be followed up within a week, two weeks, one month, and two months after the first appointment to record the periodontal indexes. The components of the toothpaste are: Water, Sorbitol, Glycerine, Silica-Ab, Silica-Th, Salvadora Persica extract, S.L.S, C.M.C, NaF, Food Flavoring, C.I.77891, C.I.19140, Caustic soda, Sodium saccharin, Methyl Paraben, Carbomer, C.I.42090. Intervention 2: Control group: On the first appointment after the clinical periodontal examinations, the patient will receive phase one treatment: Root planing and scaling (SRP), and then will be given an ordinary toothpaste with similar components as the interventions groups toothpaste but without Persica extract (Goltash company, Isfahan, Iran) to use twice a day, before sleep and after breakfast, each time in the size of a pea and then brush their teeth using the Rolling method. The patient will also be given dental floss to use after brushing their teeth. later on, the patient will be followed up within a week, two weeks, one month, and two months after the first appointment to record the periodontal indexes. The components of the toothpaste are: Water, Sorbitol, Glycerine, Silica-Ab, Silica-Th, S.L.S, C.M.C, NaF, Food Flavoring, C.I.77891, C.I.19140, Caustic soda, Sodium saccharin, Methyl Paraben, Carbomer, C.I.42090. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Houriyeh Radanfar
No 23, Nasr 1 Alley, Shahed Ave,Deh haqi street, South Nabard Blvd, Mahallati Hwy, Tehran
Tehran Iran (Islamic Republic of) 1777893556 +98 21 3631 6736 hradanfar@gmail.com Tehran University of Medical Sciences scientific Neda Moslemi
Dentistry Faculty, Ghods ave., Keshavarz Blv.
Tehran Iran (Islamic Republic of) 1439955991 +98 21 8897 3902 nmoslemi@razi.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Ages 18 to 75 The patient must have at least 20 teeth without crown restorations or cavities Patient of plaque induces gingivitis BIP positive or a change in gingival margin color The patient is willing to participate 18 years 75 years Both The cause of gingivitis isn't plaque Patient has been taking antibiotics or anti inflammatory drugs repeatedly within the past 3 months Pregnant or lactating women Patient with systemic or immunity problems Smoker Pocket depth > 4mm Patient with clinical attachment loss Patient with not acceptable partial prosthesis, restorations or bridges Patient using orthodontic appliances Patient with a history of allergic reactions to chemicals Patient using mouth rinse K05.00 Acute gingivitis, plaque induced Treatment - Drugs Placebo Intervention group: On the first appointment after the clinical periodontal examinations, the patient will receive phase one treatment: Root planing and scaling (SRP), and then will be given a Persica-containing toothpaste (Commercially known as Dentamax herbal toothpaste, Goltash company, Isfahan, Iran) to use twice a day, before sleep and after breakfast, each time in the size of a pea and then brush their teeth using the Rolling method. The patient will also be given dental floss to use after brushing their teeth. later on, the patient will be followed up within a week, two weeks, one month, and two months after the first appointment to record the periodontal indexes. The components of the toothpaste are: Water, Sorbitol, Glycerine, Silica-Ab, Silica-Th, Salvadora Persica extract, S.L.S, C.M.C, NaF, Food Flavoring, C.I.77891, C.I.19140, Caustic soda, Sodium saccharin, Methyl Paraben, Carbomer, C.I.42090 Control group: On the first appointment after the clinical periodontal examinations, the patient will receive phase one treatment: Root planing and scaling (SRP), and then will be given an ordinary toothpaste with similar components as the interventions groups toothpaste but without Persica extract (Goltash company, Isfahan, Iran) to use twice a day, before sleep and after breakfast, each time in the size of a pea and then brush their teeth using the Rolling method. The patient will also be given dental floss to use after brushing their teeth. later on, the patient will be followed up within a week, two weeks, one month, and two months after the first appointment to record the periodontal indexes. The components of the toothpaste are: Water, Sorbitol, Glycerine, Silica-Ab, Silica-Th, S.L.S, C.M.C, NaF, Food Flavoring, C.I.77891, C.I.19140, Caustic soda, Sodium saccharin, Methyl Paraben, Carbomer, C.I.42090 Modified gingival index. Timepoint: Baseline; 1 week; 2 weeks; 1 month; 2 months after phase 1 treatment. Method of measurement: Clinical examination. Full mouth plaque score. Timepoint: Baseline; 1 week; 2 weeks; 1 month; 2 months after phase 1 treatment. Method of measurement: Clinical examination. Full mouth bleeding score. Timepoint: Baseline; 1 week; 2 weeks; 1 month; 2 months after phase 1 treatment. Method of measurement: Clinical examination. Goltash company, Paksan Approved 2022-06-28 Ethic committee of Vice chancellor for research, Tehran University of Medical Sciences Ghods st, Keshavarz blvrd Tehran Tehran Iran (Islamic Republic of)