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this study addresses the effect of the vitamin B3 and vitamin B9 on the periodontal healing at the sites of periodontal destruction due to periodontitis and evaluate its added effect to the conventional non-surgical periodontal treatment on its pivotal role in the biological activities and repair in the body in general and the periodontium in specific. The research will be conducted on patients suffering from stage I and II periodontitis that typically are to be treated with non surgical periodontal therapy, the rationale of the non surgical periodontal treatment is eliminating the plaque biofilm responsible for stimulation of host immune defense causing the inflammation and hence suppressing the periodontal destruction.
the trial is targeting enhancing the treatment effect by the administration of vitamin B3 and B9 supplements which will target the host inflammatory reaction itself and directly suppressing it as well as enhancing the periodontal regeneration and the gain of the lost attachment.
This study is a parallel group randomized, Double-blinded, Placebo-controlled clinical trial The follow up of this study is set to be in a three months interval in order to monitor the effect of the periodontal treatment with/without vitamin B-3 and B-9 supplement on the periodontal repair and regeneration
The eligible patients will be randomized into three groups with four interventions:
Periodontal maintenance appointments which will include a review of medical and dental histories, supra- and subgingival instrumentation if needed, and oral hygiene instructions and motivation will be performed at 14, 30, 60 and 90 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vitamin B3 | Experimental | Vitamin B-3 capsule consists of Manufacturer: DSM Nutritional products Ltd generic name: nicotine amide Constituent components: 100mg of nicotine amide Route of administration: orally dosing schedule:1capsule/day/ before meal duration: for 30 days |
|
| Vitamin B-9 | Experimental | Vitamin B-9 capsule Manufacturer: Hebei Jiheng pharmaceutical Co. Ltd generic name: folic acid. Constituent components: 5 mg of folic acid. Route of administration: orally dosing schedule: 1capsule/day/before meal duration: for 30 days |
|
| Placebo capsule | Placebo Comparator | Placebo capsule Manufacturer: Shivangan Foods & Pharma Products Pvt. Ltd Constituent components: inactive fillers Route of administration: orally dosing schedule: 1capsule/day/before meal duration: for 30 days |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin B3 100 MG Oral Tablet | Drug | After the non surgical treatment and the oral hygiene instructions The systemically administered vitamin B3 capsules will then given to the patients under the previously mentioned dosage. |
| Measure | Description | Time Frame |
|---|---|---|
| change form the baseline in myeloperoxidase level in gingival crevicular fluid at 90 days | biological sample of GCF will be collected and the enzyme level in GCF will be measured using The enzyme-linked immunosorbent assay (ELISA) | baseline and 90 days |
| change form the baseline in clinical attachment level at 90 days | Using a University of North Carolina probe (UNC) -15 measuring the distance from the cement-enamel junction to the base of the periodontal pocket at six sites of the tooth (mesiobuccal-distobucal-midbucal-mesiolingual-distolingual-midlingual) | baseline and 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| change form the baseline in periodontal pocket depth at 90 days | Using UNC15 periodontal probe measuring the distance from the gingival margin to the base of the pocket at six sites of the tooth (mesiobuccal-distobucal-midbucal-mesiolingual-distolingual-midlingual) | baseline and 90 days |
| change form the baseline in bleeding on probing at 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elham Elkholy | Contact | +201111342530 | elham.hussien@dentistry.cu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Riham Omar, professor | main supervisor | Study Chair |
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Trial medication will be dispensed in similar colored capsules, prepacked in similar opaque white plastic jars of 30 capsules each so that neither patient nor investigator (whom is also the care provider) will know whether patient was receiving vitamin B3, B9 or placebo. the outcome assessor will be given the data coded without knowing the data for the group of patients corresponding to which intervention group.
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| vitamin B9 | Drug | After the non surgical treatment and the oral hygiene instructions the systemically administered vitamin B9 capsules will then given to the patients under the previously mentioned dosage. |
|
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| Placebo | Drug | After the non surgical treatment and the oral hygiene instructions The systemically administered placebo capsules will then given to the patients under the previously mentioned dosage. |
|
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| full mouth non surgical periodontal treatment | Procedure | full mouth scaling and debridement will be done by the primary investigator using ultrasonic scaler and periodontal curettes. After the non surgical treatment patients will be given oral hygiene instructions where they will be instructed to brush twice daily and shown how to brush using the horizontal scraping technique they will also be instructed to use the dental floss and shown how to use it. |
|
Using UNC15 periodontal probe at six sites of the tooth (mesiobuccal-distobucal-midbucal-mesiolingual-distolingual-midlingual) recorded at each site as present or absent |
| baseline and 90 days |
| change form the baseline in plaque index at 90 days | Manual UNC periodontal probe setting Scores of : 0: No plaque
| parameter will be evaluated at baseline and at 90 days |
| Patient satsification | VAS for patient satisfaction a Scale from 1-10 0 (completely dissatisfied)to 10 (completely satisfied). | Parameter will be evaluated at 90 days |
| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D010510 | Periodontal Diseases |
| D017622 | Periodontal Attachment Loss |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D055093 | Periodontal Atrophy |
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| ID | Term |
|---|---|
| D009536 | Niacinamide |
| D013607 | Tablets |
| D009525 | Niacin |
| D005492 | Folic Acid |
| ID | Term |
|---|---|
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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