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RECRUITING
NCT07882394
NA

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

Sponsor: Biruni University

View on ClinicalTrials.gov

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.

Official title: Effect of Alpha-Lipoic Acid Supplementation as an Adjunct to Non-Surgical Periodontal Treatment on Biomarker Levels in Individuals With Gingivitis

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2026-08-05

Completion Date

2027-08-05

Last Updated

2026-10-20

Healthy Volunteers

Yes

Interventions

OTHER

Placebo Administration

The use of a placebo in the control group

DIETARY_SUPPLEMENT

Alpha-Lipoic Acid 200 mg

Product Name: VeNatura Alpha Lipoic Acid - Food Supplement Approval Number: 011096-06.07.2021 Manufacturer: VeNatura Sağlık Ürünleri Tic. ve San. A.Ş. Manufacturer Registration/Approval Number: TR-34-K-138907 Content: Alpha-Lipoic Acid

DIETARY_SUPPLEMENT

Alpha-Lipoic Acid 600 mg

Product Name: VeNatura Alpha Lipoic Acid - Food Supplement Approval Number: 011096-06.07.2021 Manufacturer: VeNatura Sağlık Ürünleri Tic. ve San. A.Ş. Manufacturer Registration/Approval Number: TR-34-K-138907 Content: Alpha-Lipoic Acid

Locations (1)

Biruni University

Istanbul, Turkey (Türkiye)