Gingivitis and Periodontal DiseasesNCT07882394
Alpha-Lipoic Acid as an Adjunct to Non-Surgical Periodontal Treatment in Gingivitis
A study testing Alpha-Lipoic Acid 200 mg and Alpha-Lipoic Acid 600 mg in people with Gingivitis and Periodontal Diseases, run by Biruni University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis and Periodontal Diseases
- What is being tested?
- Alpha-Lipoic Acid 200 mg and Alpha-Lipoic Acid 600 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Aug 2026to 5 Aug 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Biruni University
Istanbul, 34015
Burcu Karaduman, PhD, +90 444 8 276, bkaraduman@gmail.com
About this study
Official title: Effect of Alpha-Lipoic Acid Supplementation as an Adjunct to Non-Surgical Periodontal Treatment on Biomarker Levels in Individuals With Gingivitis
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.
- Conditions
- Gingivitis and Periodontal Diseases
- Being tested
- Placebo Administration, Alpha-Lipoic Acid 200 mg, Alpha-Lipoic Acid 600 mg
- Keywords
- Gingivitis, Non-Surgical Periodontal Treatment, Alpha-Lipoic Acid, Oxidative Stress, 8-Hydroxy-2'-deoxyguanosine, Malondialdehyde, Total Antioxidant Capacity, C-Reactive Protein
- Medical subject headings
- Gingivitis, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo AdministrationOther
The use of a placebo in the control group
Alpha-Lipoic Acid 200 mgDietary supplement
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
Alpha-Lipoic Acid 600 mgDietary supplement
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
| Study group | Role | What they receive |
|---|---|---|
| Periodontally Healthy Control | No intervention | Periodontally healthy participants who receive no periodontal or supplement intervention. Samples and clinical measurements are obtained at baseline only. |
| NSPT + Placebo | Placebo comparator | Participants with gingivitis who receive non-surgical periodontal treatment (NSPT) and placebo supplementation once daily for 12 weeks. Receives: Other: Placebo Administration |
| NSPT + ALA 200 mg | Experimental | 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. Receives: Dietary Supplement: Alpha-Lipoic Acid 200 mg |
| NSPT + ALA 600 mg | Experimental | 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. Receives: Dietary Supplement: Alpha-Lipoic Acid 600 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, 6 weeks, and 12 weeks after non-surgical periodontal treatment
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 6, and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start5 Aug 2026
- Primary completion5 May 2027 (estimated)
- Study completion5 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gingivitis and Periodontal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07882394
- Sponsor's protocol ID
- 26-AKD-188
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Surapaneni K, Koduganti RR, Ganapathi SN, Panthula VN, Jammula SP, Dasari R, Gireddy H, Ambati M. Efficacy of Systemic Administration of Alpha Lipoic Acid and Scaling and Root Planning in Patients with Chronic Periodontitis and Type 2 Diabetes Mellitus-A Randomised Controlled Trial. J Clin Diagn Res. 2018;12(4). doi:10.7860/JCDR/2018/29200.11397.
Akman S, Canakci V, Kara A, Tozoglu U, Arabaci T, Dagsuyu IM. Therapeutic effects of alpha lipoic acid and vitamin C on alveolar bone resorption after experimental periodontitis in rats: a biochemical, histochemical, and stereologic study. J Periodontol. 2013 May;84(5):666-74. doi: 10.1902/jop.2012.120252. Epub 2012 Jun 15.
PubMed 22702517