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IRCT20191024045232N1 IRCT 2020-11-04 Ahvaz University of Medical Sciences Comparative evaluation of locally delivered 1.2% Rosuvastatin gel, 1% Metformin gel and placebo as an adjunct to scaling and root planing in the treatment of moderate to severe chronic periodontitis patients Comparative evaluation of locally delivered 1.2% Rosuvastatin gel, 1% Metformin gel and placebo as an adjunct to scaling and root planing in the treatment of moderate to severe chronic periodontitis patients 2018-09-23 anticipated 30 Complete https://irct.ir/trial/43301 interventional Randomization: Not randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Blinding description: In this single blind study, participants did not know which of the two control or experimental groups they belonged to. But the principle investigator knew who was in what group. 2-3 Periodontitis. Intervention 1: Intervention group: In the first intervention group, treatment has been done by scaling and root planing with only single injection of 0.1ml Resuvastatin gel [consisting of 1.2% Resuvastatin (high purity that has been provided by Abidi Pharmaceutical Company), 4% hydroxypropyl methylcellulose, 5% glycerin And up to 100% water], immediately after scaling the whole mouth using a syringe with blunt tip into the pocket that has the highest probing depth and clinical attachment loss with BoP (one area per patient). In the second intervention group, treatment has been done by scaling and root planing with only single injection of 0.1ml Metformin gel [consisting of 1% Metformin (high purity that has been provided by Abidi Pharmaceutical Company), 4% hydroxypropyl methylcellulose, 5% glycerin and up to 100% water], immediately after scaling the whole mouth using a syringe with blunt tip into the pocket that has the highest probing depth and clinical attachment loss with BoP (one area per patient). Patients in both groups are given the same oral hygiene instruction and are advised not to chew any hard or sticky foods and not to brush near the treated site or to use any interdental aids for a duration of one week. No anti-inflammatory or anti-plaque mouthwash and no antibiotics are prescribed after treatment. In the recall visits, any adverse effects are recorded and any supragingival plaque or calculus is removed. Intervention 2: Control group: In the control group, treatment has been done by scaling and root planing with only single injection of 0.1ml placebo gel, immediately after scaling the whole mouth using a syringe with blunt tip into the pocket that has the highest probing depth and clinical attachment loss with BoP (one area per patient). Patients are given oral hygiene instruction similar to the intervention groups and are advised not to chew any hard or sticky foods and not to brush near the treated site or to use any interdental aids for a duration of one week. No anti-inflammatory or anti-plaque mouthwash and no antibiotics are prescribed after treatment. In the recall visits, any adverse effects are recorded and any supragingival plaque or calculus is removed. 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 Saminalsadat Ayoubi
No. 112,West 13th st.,Kianpars
Ahvaz Iran (Islamic Republic of) 6155863861 +98 61 3338 2491 Ayoubi.samin@gmail.com Ahvaz University of Medical Sciences scientific Azarnoosh Aryankia
Department of periodontics, Faculty of dentistry, Ahvaz Jundishapur University of Medical Sciences
Ahvaz Iran (Islamic Republic of) 15794 - 61357 0098 61 3311 aryankiaa@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Moderate to severe chronic periodontitis patients with probing depth≥5mm and clinical attachment loss≥3mm. Patients with no history of any kind of periodontal or antibiotic therapy in the last 6 months. no limit no limit Both Individuals with any disabling systemic disease or a systemic disease that affects the periodontium. Patients on systemic statin or metformin therapy. Diabetic patients Patients with known or suspected allergy to statins or metformin. Immunocompromised patients. Pregnant or lactating women. Individuals who use any forms of tobacco and alcoholics. K05.3 Chronic periodontitis Treatment - Drugs Placebo Intervention group: In the first intervention group, treatment has been done by scaling and root planing with only single injection of 0.1ml Resuvastatin gel [consisting of 1.2% Resuvastatin (high purity that has been provided by Abidi Pharmaceutical Company), 4% hydroxypropyl methylcellulose, 5% glycerin And up to 100% water], immediately after scaling the whole mouth using a syringe with blunt tip into the pocket that has the highest probing depth and clinical attachment loss with BoP (one area per patient). In the second intervention group, treatment has been done by scaling and root planing with only single injection of 0.1ml Metformin gel [consisting of 1% Metformin (high purity that has been provided by Abidi Pharmaceutical Company), 4% hydroxypropyl methylcellulose, 5% glycerin and up to 100% water], immediately after scaling the whole mouth using a syringe with blunt tip into the pocket that has the highest probing depth and clinical attachment loss with BoP (one area per patient). Patients in both groups are given the same oral hygiene instruction and are advised not to chew any hard or sticky foods and not to brush near the treated site or to use any interdental aids for a duration of one week. No anti-inflammatory or anti-plaque mouthwash and no antibiotics are prescribed after treatment. In the recall visits, any adverse effects are recorded and any supragingival plaque or calculus is removed. Control group: In the control group, treatment has been done by scaling and root planing with only single injection of 0.1ml placebo gel, immediately after scaling the whole mouth using a syringe with blunt tip into the pocket that has the highest probing depth and clinical attachment loss with BoP (one area per patient). Patients are given oral hygiene instruction similar to the intervention groups and are advised not to chew any hard or sticky foods and not to brush near the treated site or to use any interdental aids for a duration of one week. No anti-inflammatory or anti-plaque mouthwash and no antibiotics are prescribed after treatment. In the recall visits, any adverse effects are recorded and any supragingival plaque or calculus is removed. Pocket Probing Depth. Timepoint: Before scaling and root planing (baseline) and after 3 months. Method of measurement: UNC 15 color-coded periodontal probe. Clinical Attachment Level. Timepoint: Before scaling and root planing (baseline) and after 3 months. Method of measurement: UNC 15 color-coded periodontal probe. Modified Sulcus Bleeding Index. Timepoint: Before scaling and root planing (baseline) and after 3 months. Method of measurement: Scoring system of Mombelli. Plaque Index. Timepoint: Before scaling and root planing (baseline) and after 3 months. Method of measurement: Scoring system of Silness and Loe. Ahvaz University of Medical Sciences Approved 2019-09-21 Ethics committee of Ahvaz Jundishapur University of Medical Scineces No. 112,West 13th st.,Kianpars Ahvaz Khouzestan Iran (Islamic Republic of)