Effect of Omega 3 as an Immunomodulator Adjunct to Periodontal Debridement

NCT04389931 | Completed DMC

• 1 other identifier: 047
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Periodontitis

Keywords

Fatty Acids, Omega-3; Periodontal debridement; Immunomodulation; Periodontitis

Outcome Measures

Primary Outcomes (1)

• Difference between groups for the mean of sites with Probing depth (PD) ≤ 3 mm, PD ≥ 4 mm and PD ≥ 7 mm in stage II or III grade B periodontitis patients, before and 1, 3 and 6 month after SRP with placebo or Omega 3.

  Before, 1, 3 and 6 month after performing SRP with placebo or Omega 3, PD was measured in all the patients in the study and corresponds to the distance in millimeters from the gingival margin (MG) to the inserted probe´s tip of the most apical portion of the periodontal pocket. It was obtained by measuring with a North Carolina periodontal probe (Hu-Friedy® Manufacturing Inc., Chicago, IL, USA), from the bottom of the pocket to the MG, in a position parallel to the vertical axis of the tooth, with a pressure no greater than 0.25 Newton (N). PD was performed in a circular direction over the entire surface of each tooth, registering the 6 deepest sites per tooth (mesiobuccal, buccal, distobuccal,distolingual, lingual and mesiolingual). Subsequently, those sites with PD ≥ 3 mm, PD ≥ 4 mm, PD ≥ 7 mm were counted and the student t test was applied to observe if there were significant differences between both treatment groups.

  Baseline,1,3 and 6 month.

Secondary Outcomes (5)

• Risk for disease progression, according to Lang & Tonetti (2003).

  Baseline and 6 month.

• Clinical Attachment Level (CAL) gain in the sixth month after SRP with placebo or Omega 3.

  Baseline and 6 month.

• Difference between groups for the Biofilm Index (BI) ,in stage II or III grade B periodontitis patients before and 1, 3 and 6 month after performing SRP with placebo or Omega 3.

  Baseline,1, 3 and 6 month.

• Difference between groups for the bleeding on probing (BOP) Index, in stage II or III grade B periodontitis patients before and 1, 3 and 6 month after performing SRP with placebo or Omega 3.

  Baseline,1, 3 and 6 month.

• Presence of periodontopathogens before, 3 and 6 month after performing SRP with placebo or Omega 3.

  Baseline, 3 and 6 month.

Study Arms (2)

Periodontal treatment, lactose tab

PLACEBO COMPARATOR

Periodontal treatment (scaling and root planning) and two tablets containing lactose once a day for 90 days immediately after the scaling and root planning.

Other: Lactose tab

Periodontal treatment, Omega 3

EXPERIMENTAL

Periodontal treatment (scaling and root planning) and two tablets containing 1g of Omega 3 once a day for 90 days immediately after the scaling and root planning.

Drug: Omega 3

Interventions

Lactose tab OTHER

Two tablets containing lactose Procedure: Periodontal treatment Scaling and root planning

Periodontal treatment, lactose tab

Omega 3 DRUG

Two tablets containing 1g Omega 3. Procedure:Periodontal treatment Scaling and root planning

Also known as: Omega 3 fatty acid

Periodontal treatment, Omega 3

Eligibility Criteria

• Age: 39 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Nacional Andres Bello: lead

Study Sites (1)

Universidad Nacional Andres Bello

Viña del Mar, Región de Valparaíso, 2520000, Chile

Location

Related Publications (7)

• Tonetti MS, Greenwell H, Kornman KS. Staging and grading of periodontitis: Framework and proposal of a new classification and case definition. J Periodontol. 2018 Jun;89 Suppl 1:S159-S172. doi: 10.1002/JPER.18-0006.

  PMID: 29926952 BACKGROUND

• Meissner K, Bingel U, Colloca L, Wager TD, Watson A, Flaten MA. The placebo effect: advances from different methodological approaches. J Neurosci. 2011 Nov 9;31(45):16117-24. doi: 10.1523/JNEUROSCI.4099-11.2011.

  PMID: 22072664 BACKGROUND

• Suchy FJ, Brannon PM, Carpenter TO, Fernandez JR, Gilsanz V, Gould JB, Hall K, Hui SL, Lupton J, Mennella J, Miller NJ, Osganian SK, Sellmeyer DE, Wolf MA. National Institutes of Health Consensus Development Conference: lactose intolerance and health. Ann Intern Med. 2010 Jun 15;152(12):792-6. doi: 10.7326/0003-4819-152-12-201006150-00248. Epub 2010 Apr 19. No abstract available.

  PMID: 20404261 BACKGROUND

• Jellema P, Schellevis FG, van der Windt DA, Kneepkens CM, van der Horst HE. Lactose malabsorption and intolerance: a systematic review on the diagnostic value of gastrointestinal symptoms and self-reported milk intolerance. QJM. 2010 Aug;103(8):555-72. doi: 10.1093/qjmed/hcq082. Epub 2010 Jun 3.

  PMID: 20522486 BACKGROUND

• Lang NP, Tonetti MS. Periodontal risk assessment (PRA) for patients in supportive periodontal therapy (SPT). Oral Health Prev Dent. 2003;1(1):7-16.

  PMID: 15643744 RESULT

• Van Dyke TE, Hasturk H, Kantarci A, Freire MO, Nguyen D, Dalli J, Serhan CN. Proresolving nanomedicines activate bone regeneration in periodontitis. J Dent Res. 2015 Jan;94(1):148-56. doi: 10.1177/0022034514557331. Epub 2014 Nov 11.

  PMID: 25389003 RESULT

• Deore GD, Gurav AN, Patil R, Shete AR, Naiktari RS, Inamdar SP. Omega 3 fatty acids as a host modulator in chronic periodontitis patients: a randomised, double-blind, palcebo-controlled, clinical trial. J Periodontal Implant Sci. 2014 Feb;44(1):25-32. doi: 10.5051/jpis.2014.44.1.25. Epub 2014 Feb 26.

  PMID: 24616831 RESULT

MeSH Terms

Conditions

Periodontitis

Interventions

Lactose; Docosahexaenoic Acids; Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Mariely A Navarrete, MSc

  Universidad Nacional Andres Bello

  STUDY DIRECTOR

• Mariely A Navarrete Riffo, MSc

  Universidad Nacional Andres Bello

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Faculty of Dentistry Andres Bello University, Viña del Mar campus

Model Details: 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.

Study Record Dates

• First Submitted: May 10, 2020
• First Posted: May 15, 2020
• Study Start: March 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: October 1, 2016
• Last Updated: May 21, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)