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Effect of daily vitamin C supplementation with or without flavonoid supplements on periodontal and systemic conditions before and after periodontal treatment

Recruiting
Conditions
gum disease
periodontitis
10004018
Registration Number
NL-OMON46353
Lead Sponsor
niversiteit van Amsterdam
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
81
Inclusion Criteria

- age: >=18 years;
- proximal bone loss of > 3mm in 2 non-adjacent teeth,
- probing pocket depth > 3 mm and bleeding on probing on at least 25% of their total sites and documented radiographic bone loss,
- good general health.

Exclusion Criteria

- diagnosis of any acute periodontal problem which requires immediate treatment;
- use of antibiotics within the previous 6 months;
- pregnant or lactating women;
- previous initial periodontal treatment within the last year;
- current orthodontic treatment;
- use of any medication which may interfere with quercetin, or with the study outcomes.*
- current daily use of supplements containing vitamin C
- patients who have had immunotherapy (<3 months before appointment) or who need treatment for malignancy
- patients who have been irradiated in head and neck area
- patients in whom the immune response has been compromised (eg Papillon Lefèvre syndrome)
- patients who are unable to provide oral hygiene themselves (physically or mentally handicapped)
- patients with a jaw resection done
- patients with Sjögren's syndrome
* Antibiotics (incl. Prophylaxis) and regular use (more than once a week) of anti-inflammatory drugs, steroidal anti-inflammatory drugs (NSAIDs, namely Ibuprofen, Diclofenac, Acetylsalicylic acid, Naproxen) and non-steroidal anti-inflammatory drugs (corticosteroids).

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Clinical measurements:<br /><br>bleeding on pocket probing (bop),</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Clinical measurements:<br /><br><br /><br>probing pocket depth (ppd),<br /><br>clinical attachment level (cal),<br /><br>gingival recessions (rec),<br /><br>plaque (plq),<br /><br>tooth mobility (mob),<br /><br>pocket suppuration (sup).<br /><br><br /><br><br /><br>Lab variables:<br /><br><br /><br>Subgingival microbiological profile (analyses by 16S rRNA gene amplicon<br /><br>sequencing by Illumina Miseq platform),<br /><br>Systemic biomarkers HbA1C, hs-CRP, and vitamin C (from venous blood).<br /><br>high density lipids (hdl)<br /><br>low density lipids (ldl)<br /><br>creatinine (crea)<br /><br>triglycerides (trigl)<br /><br><br /><br><br /><br>General measurements:<br /><br><br /><br>Body mass index (bmi)<br /><br>Waist circumference (wc)<br /><br>Bloodpressure (bp)</p><br>
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