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IRCT20160315027056N2 IRCT 2019-08-11 Vice Chancellor for Research and Technology, Kerman University of Medical Sciences peri-implant crevicular fluid cytokine level using healing abutments An evaluation to compare peri-implant crevicular fluid cytokine level using intact manufacturer or reused healing abutments: A controlled clinical trial 2019-04-05 anticipated 50 Complete https://irct.ir/trial/39780 interventional Randomization: Not randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: The blinding process is in such a way that the healing abutment connection to implant is done by the corresponding surgeon while the patient is completely unaware of the types of healing abutments. After 2 months, all measurements and peri-implant crevicular fluid sampling from implants are done by one experienced dentist, who is unaware of the types of healing abutments. Based on the patient and implant placement area, a number is assigned to each sampling tube. This way, the person responsible for conducting the ELISA test is also unaware of the types of samples. All clinical measurements are done by the corresponding dentist and are recorded in the patient form by the dentist assistant. Finally, the gathered information is divided into two groups and presented to the person in charge of performing statistical tests who is unaware of each group. 3 Peri-implant mucositis. Intervention 1: Intervention group: The group in which reused healing abutment (Dio Pars.Co) is attached to the implant. Intervention 2: Control group: The group in which intact manufacturer healing abutment is attached to the implant. Yes - There is a plan to make this available What will be shared: The results of the study will be reported without mentioning patient information When: 6 months after publishing the results To whom: Researchers working in academic and scientific research centers Conditions: In order to do the same study, or to apply in industry Where to obtain: Please email the person responsible for answering nazilalashkarizadeh@yahoo.com How to obtain: In the case of doing researches, the proposal, the reason for the need for the data and name of the research supporting organization should be sent to the email. If industrial companies are the applicant for the research data they should send the purpose and required documents for the originality of the company to the email mentioned. Comments:
public Nazila Lashkarizadeh
Periodontology department, Dental school, End of Shafa street, Jomhoori Eslami Boulevard, Kerman
Kerman Iran (Islamic Republic of) 7618759689 +98 34 3211 9021 nazilalashkarizadeh@yahoo.com Kerman University of Medical Sciences scientific Nazila Lashkarizadeh
Periodontology department, Dental school, End of Shafa street, Jomhoori Eslami Boulevard, Kerman
Kerman Iran (Islamic Republic of) 7618759689 +98 34 3211 9023 nazilalashkarizadeh@yahoo.com Kerman University of Medical Sciences Iran (Islamic Republic of) Age of the patient should be over 18 Implant treatment should be performed in patients with partial or complete edentulous Bone level implant placement in one stage and obtaining suitable primary stability should be possible. Good patient compliance, reference for follow-up visits and observation of post operation instructions should also be possible. 18 years no limit Both Patients who have periodontal disease Conditions that affect the immune system such as diabetes and pregnancy The habit of smoking and alcohol or tobacco consumption History of Antibiotics, anti-inflammatory, and immunosuppressive drugs intake three months before the study. Z96.5 Presence of tooth-root and mandibular implants Treatment - Devices Treatment - Devices Intervention group: The group in which reused healing abutment (Dio Pars.Co) is attached to the implant. Control group: The group in which intact manufacturer healing abutment is attached to the implant. Interleukin-1β cytokine. Timepoint: Two months after the intervention. Method of measurement: Enzyme-Linked Immunosorbent Assay (ELISA) human kits (HANGZHOU EASTBIOPHARM CO.LTD.) for evaluation of interleukin 1β levels. Tumor Necrotizing Factor α cytokine. Timepoint: Two months after the intervention. Method of measurement: Enzyme-Linked Immunosorbent Assay (ELISA) human kits (HANGZHOU EASTBIOPHARM CO.LTD.) for evaluation of interleukin 1β levels. Plaque Index (Ainamo & Bay 1975). Timepoint: 2 months after the intervention. Method of measurement: Observation in such a way that if the plaque is visible on each of the buccal, lingual, mesial or distal surface of healing abutment 0 code and if it is not visible code 1 is assigned. Bleeding Index (Ainamo & Bay). Timepoint: 2 months after the intervention. Method of measurement: Observation in such a way that if bleeding on probing is visible on each of the buccal, lingual, mesial or distal surface of healing abutment 0 code and if it is not visible code 1 is assigned. Vice Chancellor for Research and Technology, Kerman University of Medical Sciences Approved 2019-05-29 Ethics Committee of Kerman University of Medical Sciences Ethics Committee, Vice Chancellor for Research and Technology of University of Medical Sciences Building, First of Ebne Sina Street, Jahad Boulevard, Sommaye Cross road, Kerman Kerman Kerman Iran (Islamic Republic of)