Effect of Omega 3 as an Immunomodulator Adjunct to Periodontal Debridement

• Status: Completed
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Universidad Nacional Andres Bello

Criteria

Inclusion Criteria:

• Patients ≥ 18 years.

• Patients American Society of Anesthesiologists (ASA) I or ASA II compatible with local anesthesia procedures.

• Present at least 10 natural teeth, excluding semi-erupted third molars.

• Present at least 6 sites with a probing depth (PD) ≥ 5mm and clinical attachment loss (CAL) ≥ 4mm

Exclusion Criteria:

• Patients with hemostasis disorders.

• Patients who use any medication associated with gingival disorders such as:

Anticonvulsants (Phenytoin), Calcium channel blockers (Nifedipine), Immunosuppressive drugs (Cyclosporins).

• Patients with systemic diseases that affect the immunoinflammatory response.

• Patients under treatment with antacids on a regular basis due to chronic gastritis and / or self-medication with antacids.

• Patients under treatment with drugs such as: warfarin, digoxin and acetylsalicylic acid.

• Previous history of allergy to local anesthetics.

• Patients presenting orthodontic appliances.

• Patients who have received antibiotic treatment in the last 3 months.

• Patients who have received periodontal treatment.

• Pregnancy.

• Carriers of valvular prostheses or failures in heart valves, with endocarditis risk.

• Patients who are physically and intellectually incapacitated to participate, according to chilean law number 20,584, title II, paragraph 8, article 28.

• Heavy smoking patients, which is smoking more than 10 cigarettes per day.

• Patients allergic to Omega 3 or seafood or its derivatives: fish, shellfish, algae, etc.

• Patients with lactose intolerance.