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Recruiting NCT07882394

Alpha-Lipoic Acid as an Adjunct to Non-Surgical Periodontal Treatment in Gingivitis

Conditions: Gingivitis and Periodontal Diseases

Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 80
Sponsor: Biruni University

Location: Biruni University Istanbul

Summary

Gingivitis is an early and reversible form of periodontal disease characterized by an increased inflammatory response to dental biofilm. As gingivitis progresses, increased production of reactive oxygen species as part of the host response contributes to oxidative stress, leading to structural damage to DNA, proteins, and lipids in both local and systemic biological environments. One of the major indicators of this oxidative process is 8-hydroxy-2'-deoxyguanosine (8-OHdG), a critical biomarker reflecting the biochemical severity of periodontal inflammation. In addition, malondialdehyde (MDA), an end product of lipid peroxidation, reflects the level of oxidative stress, whereas total antioxidant capacity (TAC) serves as a complementary biochemical marker for assessing the antioxidant defense response of the host. Furthermore, C-reactive protein (CRP), a marker of systemic inflammation, may provide valuable information regarding the effects of gingival inflammation on the host. Non-surgical periodontal treatment (NSPT) is the standard treatment approach for gingivitis; however, oxidative stress may not be completely suppressed following treatment, and persistent alterations in certain biomarkers may remain. Alpha-lipoic acid (ALA) is a potent antioxidant capable of neutralizing reactive oxygen species, supporting endogenous antioxidant systems, and exerting antioxidant activity in both lipid- and aqueous-phase environments. However, no clinical study has evaluated the effects of systemic ALA supplementation as an adjunct to NSPT on 8-OHdG, MDA, TAC, and CRP levels in individuals with gingivitis. Therefore, this study aims to analyze 8-OHdG, MDA, TAC, and CRP levels in saliva and serum samples from periodontally healthy individuals and individuals with gingivitis and to determine the effects of adjunctive ALA supplementation to NSPT on biomarkers of oxidative stress and inflammation. This approach is expected to provide novel evidence regarding the potential biochemical benefits of antioxidant supplementation in the management of gingivitis.

Eligibility Criteria

Inclusion Criteria: Aged 18-65 years Systemically healthy Having ≥20 natural teeth No periodontal treatment within the previous 6 months No use of antibiotics or non-steroidal anti-inflammatory drugs (NSAIDs) within the previous 3 months Non-smokers Willing to participate voluntarily and provide informed consent Exclusion Criteria: Use of immunosuppressive medications or corticosteroids Pregnancy or lactation Current orthodontic treatment Excessive alcohol consumption or substance abuse Non-compliance with the study protocol or treatment requirements

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07882394). StuddyBuddy aggregates publicly available trial information.