An interventional study of Placebo Administration and Alpha-Lipoic Acid 200 mg in Gingivitis and Periodontal Diseases, sponsored by Biruni University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Biruni University · Not applicable, Interventional, and Treatment
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.
609 studies on the registry are indexed under Gingivitis; 107 are open to participants now.
This study's planned enrollment of 80 is above the median of 63 across 494 interventional studies indexed under Gingivitis.
Browse Gingivitis studies →Biruni University is the lead sponsor of 179 studies on the registry; 44 are open to participants now.
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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
Periodontally healthy participants who receive no periodontal or supplement intervention. Samples and clinical measurements are obtained at baseline only.
Participants with gingivitis who receive non-surgical periodontal treatment (NSPT) and placebo supplementation once daily for 12 weeks.
Other: Placebo Administration
Participants with gingivitis who receive non-surgical periodontal treatment (NSPT) and alpha-lipoic acid (ALA) supplementation at a dose of 200 mg/day for 12 weeks.
Dietary Supplement: Alpha-Lipoic Acid 200 mg
Participants with gingivitis who receive non-surgical periodontal treatment (NSPT) and alpha-lipoic acid (ALA) supplementation at a dose of 600 mg/day for 12 weeks.
Dietary Supplement: Alpha-Lipoic Acid 600 mg
The use of a placebo in the control group
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
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
Salivary 8-OHdG
Evaluation of changes in salivary 8-OHdG levels following non-surgical periodontal treatment combined with alpha-lipoic acid (ALA) or placebo supplementation in individuals with gingivitis. Salivary 8-OHdG levels will be measured using an enzyme-linked immunosorbent assay (ELISA).
Time frame: Baseline, 6 weeks, and 12 weeks after non-surgical periodontal treatment
Changes in Probing Pocket Depth (PPD)
Evaluation of changes in probing pocket depth following non-surgical periodontal therapy combined with ALA or placebo supplementation in individuals with gingivitis.
Time frame: Baseline, Week 6, and Week 12
Changes in Bleeding on Probing
Assessment of changes in bleeding on probing values following non-surgical periodontal therapy combined with ALA or placebo supplementation in individuals with gingivitis.
Time frame: Baseline, Week 6, and Week 12
Changes in Plaque Score (PS)
Assessment of changes in plaque score following non-surgical periodontal therapy combined with ALA or placebo supplementation in individuals with gingivitis. Plaque score will be calculated as the percentage of tooth surfaces with detectable plaque.
Time frame: Baseline, Week 6, and Week 12
Changes in Salivary MDA, TAC, and CRP Levels
Evaluation of changes in salivary oxidative stress and inflammatory biomarkers, including MDA, TAC, and CRP levels, following non-surgical periodontal therapy combined with ALA or placebo supplementation in individuals with gingivitis.
Time frame: Baseline, Week 6, and Week 12
Changes in Serum 8-OHdG, MDA, TAC, and CRP Levels
Evaluation of changes in serum oxidative stress and inflammatory biomarkers, including 8-OHdG, MDA, TAC, and CRP levels, following non-surgical periodontal therapy combined with ALA or placebo supplementation in individuals with gingivitis.
Time frame: Baseline, Week 6, and Week 12
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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