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Effects of Omega-3 Supplementation on inflammatory and oxidative stress markers in the blood and tissues of patients with Endodontic Lesions

Effects of Omega-3 on salivary and plasma redox biomarkers in patients with Secondary Endodontic Lesions

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-9mjfj86
Enrollment
24
Registered
2026-05-11
Start date
2025-04-09
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periapical Periodontitis

Interventions

This is a controlled, non-randomized, open-label clinical study with three groups, including a total of 24 participants of both sexes who meet the inclusion criteria, with blinding of the personnel re
subsequent participants will be allocated alternately until the groups are completed. The groups will be organized as follows: Group 1, supplemented healthy group: 8 systemically healthy participants
Group 2, lesion group with supplementation: 8 participants with persistent asymptomatic apical periodontitis, previously submitted to unsuccessful endodontic treatment and with an indication for peria
Group 3, lesion group without supplementation: 8 participants with persistent asymptomatic apical periodontitis, previously submitted to unsuccessful endodontic treatment and with an indication for pe

Sponsors

Faculdade de Odontologia de Araçatuba - Universidade Estadual Paulista
Lead Sponsor
Faculdade de Odontologia de Araçatuba - Universidade Estadual Paulista
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Participants of both sexes; systemically healthy patients; patients with persistent periapical periodontitis; teeth previously submitted to endodontic treatment or retreatment; indication for periapical surgery; persistent periapical lesion with a diameter greater than or equal to 2.5 mm; incisors; canines; premolars; maxillary or mandibular teeth; unsuccessful conventional endodontic treatment; persistence of the periapical lesion; inability to obtain adequate access to the root canal system; anatomical alterations that hinder conventional treatment; endodontic retreatment without clinical success; for the healthy supplemented group absence of need for endodontic intervention; absence of need for periodontal intervention; absence of clinical signs of periapical disease; absence of radiographic signs of periapical disease

Exclusion criteria

Exclusion criteria: Chronic systemic diseases; continuous use of medications; antibiotic use within the last 3 months; anti-inflammatory drug use within the last 30 days; presence of a partial prosthesis; presence of complete dentures; spontaneous pain; throbbing pain; sharp pain; positive response to palpation; positive response to percussion; abscess; presence of a sinus tract; advanced periodontal disease; periodontal probing depth greater than 3 mm; primary endodontic infection; history of dental trauma; cardiovascular risk factors; arterial hypertension; dyslipidemia; diabetes mellitus; obesity; current smoking; previous smoking; for women use of contraceptive hormones; for the healthy supplemented group need for endodontic intervention; reversible pulpitis; irreversible pulpitis; pulp necrosis; primary periapical periodontitis; presence of caries; presence of periodontal disease

Design outcomes

Primary

MeasureTime frame
Modulation of salivary and plasma redox status is expected to be observed after 40 days of omega-3 supplementation, verified through biochemical analysis of the levels of thiobarbituric acid reactive substances, protein carbonyls, total oxidant capacity, ferric reducing antioxidant power, reduced glutathione, uric acid, superoxide dismutase, catalase, and glutathione peroxidase in saliva and plasma samples collected on day 0 and day 41. The outcome will be verified based on the observation of variation in the values of these biomarkers between the pre- and post-intervention time points and by comparison between the evaluated groups, considering the presence of a statistically significant difference when the p-value is less than 0.05 as the parameter indicating occurrence of the outcome

Secondary

MeasureTime frame
Modulation of the plasma inflammatory profile is expected to be observed after 40 days of omega-3 supplementation, verified through the analysis of the levels of matrix metalloproteinase 2, matrix metalloproteinase 9, interferon gamma, interleukin 1 beta, interleukin 4, interleukin 6, interleukin 8, interleukin 10, interleukin 13, interleukin 17A, interleukin 18, monocyte chemoattractant protein 1, platelet-derived growth factor AB/BB, tumor necrosis factor alpha, and vascular endothelial growth factor A in plasma samples collected on day 0 and day 41. The outcome will be verified based on the observation of variation in the values of these biomarkers between the pre- and post-supplementation time points and by comparison between the evaluated groups, considering the presence of a statistically significant difference when the p-value is less than 0.05 as the parameter indicating occurrence of the outcome;Modulation of the tissue inflammatory profile of persistent periapical lesions associated with omega-3 supplementation is expected to be observed, verified through the analysis of the levels of matrix metalloproteinase 2, matrix metalloproteinase 9, interferon gamma, interleukin 1 beta, interleukin 4, interleukin 6, interleukin 8, interleukin 10, interleukin 13, interleukin 17A, interleukin 18, monocyte chemoattractant protein 1, platelet-derived growth factor AB/BB, tumor necrosis factor alpha, and vascular endothelial growth factor A in periapical tissue samples obtained during the surgical procedure. The outcome will be verified by comparing the levels of these biomarkers between supplemented participants with persistent periapical periodontitis and participants with persistent periapical periodontitis without supplementation, considering the presence of a statistically significant difference when the p-value is less than 0.05 as the parameter indicating occurrence of the outcome

Countries

BR

Contacts

Public ContactRogério Jacinto

Faculdade de Odontologia de Araçatuba - Universidade Estadual Paulista

rogerio.castilho@unesp.br+55(18)3636-3278

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Jun 11, 2026