Effects of omega-3 supplementation as an adjunct to non-surgical periodontal therapy on periodontal parameters in periodontitis patients: a randomized clinical trial

This study was conducted at the Periodontics Department of School of Dentistry, Yazd University of Medical Sciences between August 2021 and March 2022. The study was approved by the ethics committee of this university (IR.SSU.REC.1400.025) and at 17/07/2021 registered in the Iranian Registry of Clinical Trials (IRCT20151013024509N5).

Trial design

A parallel-design randomized clinical trial was conducted in which, the intervention group received omega-3 supplementation for 3 months after SRP while the control group received placebo for 3 months after SRP. The results were reported in accordance with the Consolidated Standards of Reporting Trials.

Participants, eligibility criteria, and settings

The inclusion criteria were periodontitis staged as II to IV and graded as B. [29], (II) age between 30 and 70 years, (III) no cigarette smoking or tobacco use, (IV) no history of periodontal therapy, (V) no history of antibiotic use in the past 3 months, (VI) absence of diseases or conditions that would interfere with wound healing such as diabetes mellitus or coagulation disorders, (VII) absence of oral mucosal inflammatory conditions such as aphthous ulcers or lichen planus, (VIII) no intake of medications affecting the periodontium such as anticonvulsants, calcium channel blockers, or immunosuppressant drugs, no history of seafood allergy (IX) and (X) no pregnancy or nursing.

The exclusion criteria were (I) not showing up for the 1-month or 3-month follow-ups, and (II) no or poor adherence to the instructions regarding omega-3 supplementation, or oral hygiene instructions at the 1-month follow-up.

The sample consisted of 30 patients with periodontitis presenting to the Periodontics Department of School of Dentistry, Yazd University of Medical Sciences for periodontal therapy.

Informed consent

Informed consent was obtained from the patients to participate in the study and to use the results obtained from the study by the post-graduate student.

Interventions

Written informed consent was obtained from all patients after they were briefed about the study. When gingival inflammation symptoms such as erythema, edema and tendency to bleeding on probing and the interdental CAL ≥ 3 mm was present and apart from the number of tooth loss the diagnosis was recorded as periodontitis with stage II ( moderate periodontitis) to stage IV (advanced periodontitis with extensive tooth loss) according to 2017 international periodontology workshop. As mentioned before, absence of risk factors for example smoking and systemic conditions such as diabetes which affected grading, were considered as inclusion criteria. So progression was as expected (grade B). No full-mouth PA radiographs available, should be considered as one of the limitations of this study.

The CAL, PD and bleeding index (BI) [30] were measured for each patient and recorded at baseline. Next, all patients received SRP with an ultrasonic scaler (Various 350; NSK, Japan) and a manual universal curette (Gracey; Hu-Friday, Chicago, USA) by a post-graduate student of periodontics. They also received prophylaxis with a prophy brush and prophy paste. The modified Bass tooth brushing technique was then instructed to patients on a model. Patients were asked to brush their teeth twice a day after meals.

Next, the patients were randomly assigned to two groups, and were standardized in terms of age, gender distribution, and severity of periodontal disease based on the mean baseline PD, CAL, and BI.

Fish oil mercury-free soft-gels (n = 1350, 1000 mg each) containing natural fish oil ( 300 mg Omega-3 marine triglycerides, 180 mg Eicosapentaenoic acid and 120 mg Docosahexaenoic acid) and control soft-gels containing only soybean oil were produced by Yas- Kavir pharmaceuticals. The intervention group received 1000 mg omega-3 soft-gels while the control group received soft-gels containing very small amount of soybean oil to only make the gelatinous capsule not look empty (150 mg). Both groups were instructed to use one soft-gel daily for 3 months [23]. Accordingly, each group received three bottles, each containing 30 soft-gels. The patients were recalled at 1 month to ensure their adherence to oral hygiene instructions. The patients were requested to continue using the supplement. The patients were recalled again at 3 months, and their PD, CAL, and BI were measured again.

Outcomes (primary and secondary)

The primary outcomes of this study was evaluating CAL before and after the intervention. The secondary main objective of this study was to assess BI & PD probable changes according to the usage of omega-3 supplementation following SRP on clinical improvement in patients with periodontitis.

Sample size calculation

The sample size was calculated to be at least 15 in each group according to a study by Kruse et al., [25] considering alpha = 5%, study power of 80%, standard deviation of CAL to be 0.7, and a minimum significant difference of 0.6 unit in CAL between the two groups.

Interim analyses and stopping guidelines

No interim analyses were performed, and no stopping guidelines were established.

Randomization

The patients were randomly assigned to the intervention and control groups by a table of random numbers generated by Random Allocation Software version 1.0.( Mahmood Saghaei, Iran).

Blinding

The study had a double-blind design. Both omega-3 and soybean oil soft-gels had the same shape and color and similar packaging. A pharmacist not involved in the study coded the soft-gels A and B based on their content and administered them among the patients. The dental clinician who measured the clinical periodontal parameters and the patients were not aware of the group allocation of soft-gels. The statistician who analyzed the data was also blinded to the group allocation of data.

Statistical analysis

Data were analyzed by SPSS version 25 (SPSS Inc., IL, USA). Normal distribution of data was evaluated by the Kolmogorov-Smirnov test. Comparisons were made by paired t-test and t-test at 0.05 level of significance.

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