Effect of Adjunctive Use of Vitamin B3 and B9 on Myeloperoxidase Level in the GCF of Patients With Stage I and II Periodontitis

NCT05435378 | Unknown Early Phase 1

• 1 other identifier: PER 3.3.2
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Periodontitis Stage I; Periodontal Diseases; Periodontal Inflammation; Periodontal Attachment Loss; Periodontitis; Periodontitis Stage II

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• change form the baseline in periodontal pocket depth at 90 days

  baseline and 90 days

• change form the baseline in bleeding on probing at 90 days

  baseline and 90 days

• change form the baseline in plaque index at 90 days

  parameter will be evaluated at baseline and at 90 days

• Patient satsification

  Parameter will be evaluated at 90 days

Study Arms (3)

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

Drug: Vitamin B3 100 MG Oral Tablet; Procedure: full mouth non surgical periodontal treatment

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

Drug: vitamin B9; Procedure: full mouth non surgical periodontal treatment

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

Drug: Placebo; Procedure: full mouth non surgical periodontal treatment

Interventions

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.

Also known as: niacin, niacinamide, nicotinamide

vitamin B3

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.

Also known as: Folic acid, Folate, folacin

Vitamin B-9

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.

Also known as: inactive drug

Placebo capsule

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.

Placebo capsule; Vitamin B-9; vitamin B3

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with gingivitis or stage I/II periodontits. The presence of gingivitis and the presence/severity of periodontitis is registered using the American Academy of Periodontology 2017 workshop published definition With this method, patient was identified affected by periodontits when ''Interdental CAL is detectable at ≥2 non-adjacent teeth, or Buccal/oral CAL ≥3 mm with pocketing \>3 mm is detectable at ≥2 teeth'' (Toentti et al, 2018) with grade I severity being cases with interdental CAL from 1-2mm and grade II severity being cases with interdental CAL from 3-4 mm

You may not qualify if:

• Patients incapable of giving informed consent
• Patients unable to attend the 3-month follow-up
• Patients with interdental CAL \>4mm
• Patient requiring surgical periodontal treatment
• Patients on systemically administered vitamin B or vitamin B-complex
• Patients undergoing chemo- or immunosuppressive therapy over the previous 5 years
• Patients treated or undergoing treatment with intravenous amino-bisphosphonates
• Patients with poor oral motivation
• Substance abusers

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Periodontitis; Periodontal Diseases; Periodontal Attachment Loss

Interventions

Niacinamide; Tablets; Niacin; Folic Acid

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Intervention Hierarchy (Ancestors)

Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Dosage Forms; Pharmaceutical Preparations; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Riham Omar, professor

  main supervisor

  STUDY CHAIR

Central Study Contacts

Elham Elkholy

CONTACT

+201111342530; elham.hussien@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: June 17, 2022
• First Posted: June 28, 2022
• Study Start: July 1, 2022
• Primary Completion: October 1, 2022
• Study Completion: December 1, 2022
• Last Updated: June 28, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share