Study design and patient selection
Subject
GENERALIZED PERIODONTITIS, ORAL DISEASE, RECRUITMENT, POLAND, PLAQUE, HIV PERIODONTITIS
The study was designed as a parallel-arm, randomized clinical trial. A six-month trial period was set: (i) baseline, (ii) 3 weeks (oral hygiene professional control); (iii) 3 months, (iiii) 6 months. The study protocol was approved by the Ethical Committee of Medical University of Lodz (reference number RNN/251/17/KE) and registered at clinicaltrials.gov (NCT04477395) on 20/07/2020. The study was conducted in accordance with the Declaration of Helsinki and all patients provided their informed consent. The study was performed between October 2017 and April 2021. Study participants were consecutively screened and enrolled at the Department of Periodontology and Oral Diseases, Medical University of Lodz by M.S. and N.L. Patients with severe generalized periodontitis fulfilling the criteria for stage III or IV periodontitis were invited to participate in the study. The participants were randomly assigned to one of the two treatment groups. The allocation sequence was generated by the investigator (P.L.) who was not involved in the recruitment of participants for the study by using a website Following first step of periodontal therapy that included oral hygiene instructions and professional mechanical plaque removal [Patients from the control group were treated by SRP only. Patients from the test group received additionally fish oil containing omega-3 PUFAs for 6 months. Subject allocation was concealed in sequentially numbered opaque sealed envelopes, and at 3 weeks after completion of baseline SRP sessions, envelopes were opened to reveal subject allocation to the clinician (M.S.) responsible for treatment. Fish oil (BioMarine Medical, Marinex International, Poland), derived from Periodontal examination was performed by a periodontist (N.L.) blinded to the study allocation of patients. Treatments were performed by a PhD student (M.S.). Both periodontal examination and treatment were done under magnification using 2.7 × or 3.1 × loups.