Effect of Omega 3 as an Immunomodulator Adjunct to Periodontal Debridement
Condition: Periodontitis
MeSH terms: Periodontitis
Study type: Interventional

Summary: 
      This study evaluates the effect of the systemic administration of Omega 3 as a therapy
      associated with non-surgical periodontal treatment, in the clinical and microbiological
      variables of patients with Moderate Periodontitis with moderate rate of progression (Stage II
      grade B) and Severe Periodontitis with potential for additional tooth loss and moderate rate
      of progression (Stage III grade B). A double-blind, randomized, controlled trial was
      conducted with 18 voluntary patients with a history of moderate to severe chronic
      periodontitis, who met the inclusion and exclusion criteria and signed an informed consent.
      The intervention group received Scaling and Root Planning (SRP) plus Omega 3, and the control
      group received SRP plus placebo. Probing depth (PD), Clinical Attachment Level (CAL), Biofilm
      Index (BI) and Bleeding on Probing (BOP) were evaluated as clinical variables while
      Porphyromonas gingivalis (Pg), Tannerella forsythia (Tf), Treponema denticola (Td),
      Fusobacterium nucleatum (Fn) were the microbiological variables detected by conventional
      Polymerase chain reaction (PCR).
    

Detailed description: 
      Definition of the sample: Patients over 18 years old admitted to the Diagnostic Unit of the
      Faculty of Dentistry (DUFD), Viña del Mar campus of the University National Andres Bello
      (UNAB) during 2016, with a diagnosis of moderate or severe chronic periodontitis, meeting
      both the inclusion and exclusion criteria and voluntarily agree to participate of the present
      research work, signing an informed consent. The chosen participants were informed of the
      nature of the research, potential risks and compensation for participating in the study,
      obtaining informed consent from every patient. Sample Size Calculation: To calculate the
      minimum sample size necessary for the constitution of the control and intervention groups,
      the variance of the probing depth difference were considered as fixed values, which were
      based on the results described above.Considering the above and using a level of significance
      of 5%, a statistical power of 80% and an estimation error of 1 mm, at least 7 patients were
      obtained for each group, giving a total of 14 minimum subjects to study. Protocol and
      clinical exam: Out of a total of 31 patients who were selected, 20 of those who met the
      inclusion criteria were randomly assigned by the study coordinator to one of the two groups
      using a random generation sequence employing a software. Two subjects declined to participate
      in the research. In this way, two groups were formed to investigate: an intervention group (8
      subjects) that received SRP plus 2 g of a Omega once a day for 90 days immediately after the
      SRP, and a control group (10 subjects) that received SRP plus placebo under the same
      conditions as the intervention group. One subject of the control group and two of
      intervention, were lost during the six month control. Finally, fifteen patients entering the
      study also completed it. No compliance problems were noted, all patients followed the
      protocol of the study. None subjects reported specific adverse effects.

      Randomization: Only the main investigator, who made the randomization by using the Epidat 4.0
      program, had knowledge about the content of the containers and the group to which each
      patient belonged in the study, therefore, was in charge of labeling the containers, achieving
      in this way that collaborators and participants in the investigation did not know their
      content until after the study was finished. Standardization and calibration: The data was
      collected using instruments and supplies with the same commercial brands, in a single chair,
      under the same lighting and by a single examiner in the case of clinical data and another
      examiner for microbiological variables. The complete process of PCR was performed by a
      biochemist belonging to the microbiology laboratory, Santiago campus of the UNAB. An
      interexaminer calibration was performed, where the only clinical examiner was calibrated by a
      specialist in periodontics, recording the data obtained in a calibration sheet. For this, a
      minimum of 10 subjects were evaluated, in which a site of one tooth belonging to each
      quadrant was randomly selected. Periodontopathogens: The presence of periodontopathogens was
      considered when exposing the agarose gel of the electrophoresis to ultraviolet light, a band
      at the site of the 197 base pairs (bp) was observed in the lane possessing the patient's
      subgingival bioflora sample of Pg, 316 base pairs for Td, 745 for Tf and 167 for Fn. Data
      collection and instrument: Prior to the data collection, all subjects belonging to the study
      were asked for a panoramic radiograph for diagnostic purposes. Subsequently, the periodontal
      examination was performed registering the clinical variables described above in a clinical
      record. Obtaining microbiological samples: The microbiological examination was performed
      before SRP on both groups. The collection of microbiological samples was based on a protocol
      that is used at the University of Chile. Using sterile paper cones number 40, a sample of
      subgingival biofilm was taken from the site with the highest CAL, within those with PD ≥ 5mm,
      and an oral hygiene instruction was performed. Before the collection of subgingival biofilm,
      the area was cleaned with a sterile gauze to eliminate the supragingival biofilm. Then, with
      a tweezer, a paper cone was taken, and its tip was placed in the sulcus of the study site for
      20 seconds, to ensure the absorption of the crevicular fluid and subgingival biofilm. Each
      biological sample obtained was suspended in an Eppendorf tube with 1 ml of distilled water
      and transported in a refrigerator at a temperature of 4°C approximately, within a time not
      exceeding 3 hours, to be then temporarily stored at -80°C, until its transfer and subsequent
      extraction of deoxyribonucleic acid (DNA) and PCR technique processing. The time between
      sampling and DNA extraction did not exceed 48 hours, to avoid deterioration of the biological
      material. Periodontal Treatment: Once the preliminary collection of all the variables was
      completed, non-surgical periodontal treatment was carried out, beginning with supra and
      subgingival full-mouth decontamination, using an electric piezo (DTE®, Guilin Woodpecker
      Medical Instrument Co., Ltd., Guilin, Guangxi , People's Republic of China), followed by root
      planning at sites presenting PD ≥ 5mm and CAL≥ 4mm, using Gracey curettes (Hu-Friedy®
      Manufacturing Inc., Chicago, Illinois (IL), USA). This therapy was performed in all patients,
      both in the intervention and control group, under full mouth treatment protocol, in 1 or 2
      work sessions, lasting from 1 to 2 hours, achieving treatment within 24 hours. Omega 3 or
      placebo administration: At the end of the last treatment session, the Omega 3 (Omega 3,
      Galenic Pharmacy) or a placebo (Lactose, Galenic Pharmacy) was administered, depending on the
      group, intervention or control respectively, to which the patient belonged. For both
      therapies, the administration regimen was 2 tablets of 1g orally per day, for 90 consecutive
      days.To maintain the double-blind, the containers used for the Omega 3 and placebo presented
      the same characteristics regarding size and color. About the Omega 3 tablets and placebo,
      these were visually identical. Subsequently, at the first, third and six month after the end
      of the nonsurgical treatment, a new collection of all the clinical variables measured at the
      beginning of the study was performed, while the microbiological variables were measured again
      at the third month after treatment, from the same site used in the first sampling.
    

Intervention name(s): Lactose tab; Omega 3
Intervention type(s): Other; Drug
Intervention description(s): Two tablets containing lactose Procedure: Periodontal treatment Scaling and root planning; Two tablets containing 1g Omega 3. Procedure:Periodontal treatment Scaling and root planning
Other intervention name(s): Omega 3 fatty acid
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A double-blind, randomized controlled trial, where patients with a history of Moderate Periodontitis with moderate rate of progression (Stage II grade B) and Severe Periodontitis with potential for additional tooth loss and moderate rate of progression (Stage III grade B). The intervention group received nonsurgical periodontal therapy (SRP) plus Omega 3, and the control group received SRP plus placebo. The clinical variables were measured before the treatment, the first, third and six month of the end of the SRP, while the microbiological variables were measured before the treatment and in the third month after treatment.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Fatty Acids, Omega-3; Periodontal debridement; Immunomodulation; Periodontitis