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

Primary Purpose

Periodontitis Stage I, Periodontal Diseases, Periodontal Inflammation

Status
Not yet recruiting
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Vitamin B3 100 MG Oral Tablet
vitamin B9
Placebo
full mouth non surgical periodontal treatment
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis Stage I

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    vitamin B3

    Vitamin B-9

    Placebo capsule

    Arm Description

    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 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 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

    Outcomes

    Primary Outcome Measures

    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)
    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)

    Secondary Outcome Measures

    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)
    change form the baseline in bleeding on probing at 90 days
    Using UNC15 periodontal probe at six sites of the tooth (mesiobuccal-distobucal-midbucal-mesiolingual-distolingual-midlingual) recorded at each site as present or absent
    change form the baseline in plaque index at 90 days
    Manual UNC periodontal probe setting Scores of : 0: No plaque A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after application of a disclosing solution or by using the probe on the tooth surface. Moderate accumulation of soft deposits within the gingival pocket, or the tooth and gingival margin, which can be seen with the naked eye. Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.
    Patient satsification
    VAS for patient satisfaction a Scale from 1-10 0 (completely dissatisfied)to 10 (completely satisfied).

    Full Information

    First Posted
    June 17, 2022
    Last Updated
    June 22, 2022
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05435378
    Brief Title
    Effect of Adjunctive Use of Vitamin B3 and B9 on Myeloperoxidase Level in the GCF of Patients With Stage I and II Periodontitis
    Official Title
    Effect of Adjunctive Use of Vitamin B3 and B9 on Myeloperoxidase Level in the GCF of Patients With Stage I and II Periodontitis, a Randomized, Parallel Group, Double Blinded, Placebo Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 1, 2022 (Anticipated)
    Primary Completion Date
    October 1, 2022 (Anticipated)
    Study Completion Date
    December 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    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: Non-surgical scaling and debridement with placebo Non-surgical scaling and debridement with vitamin B-3 Non-surgical scaling and debridement with vitamin B-9 Before intervention, a gingival cervicular fluid sample will be collected for all groups to measure the myeloperoxidase level at baseline before treatment then a 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. The systemically administered vitamin B or placebo capsules will then given to the patients and instructed to be taken once daily for 30 days. Patients are instructed not to take any vitamin B supplementations during the period of treatment, patients are also instructed to discontinue using the drug if any allergic reaction appeared and directly report it to the investigator. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Periodontitis Stage I, Periodontal Diseases, Periodontal Inflammation, Periodontal Attachment Loss, Periodontitis, Periodontitis Stage II

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    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.
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    vitamin B3
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Vitamin B-9
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Placebo capsule
    Arm Type
    Placebo Comparator
    Arm Description
    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
    Intervention Type
    Drug
    Intervention Name(s)
    Vitamin B3 100 MG Oral Tablet
    Other Intervention Name(s)
    niacin, niacinamide, nicotinamide
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    vitamin B9
    Other Intervention Name(s)
    Folic acid, Folate, folacin
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Other Intervention Name(s)
    inactive drug
    Intervention Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    full mouth non surgical periodontal treatment
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    change form the baseline in myeloperoxidase level in gingival crevicular fluid at 90 days
    Description
    biological sample of GCF will be collected and the enzyme level in GCF will be measured using The enzyme-linked immunosorbent assay (ELISA)
    Time Frame
    baseline and 90 days
    Title
    change form the baseline in clinical attachment level at 90 days
    Description
    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)
    Time Frame
    baseline and 90 days
    Secondary Outcome Measure Information:
    Title
    change form the baseline in periodontal pocket depth at 90 days
    Description
    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)
    Time Frame
    baseline and 90 days
    Title
    change form the baseline in bleeding on probing at 90 days
    Description
    Using UNC15 periodontal probe at six sites of the tooth (mesiobuccal-distobucal-midbucal-mesiolingual-distolingual-midlingual) recorded at each site as present or absent
    Time Frame
    baseline and 90 days
    Title
    change form the baseline in plaque index at 90 days
    Description
    Manual UNC periodontal probe setting Scores of : 0: No plaque A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after application of a disclosing solution or by using the probe on the tooth surface. Moderate accumulation of soft deposits within the gingival pocket, or the tooth and gingival margin, which can be seen with the naked eye. Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.
    Time Frame
    parameter will be evaluated at baseline and at 90 days
    Title
    Patient satsification
    Description
    VAS for patient satisfaction a Scale from 1-10 0 (completely dissatisfied)to 10 (completely satisfied).
    Time Frame
    Parameter will be evaluated at 90 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Elham Elkholy
    Phone
    +201111342530
    Email
    elham.hussien@dentistry.cu.edu.eg
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Riham Omar, professor
    Organizational Affiliation
    main supervisor
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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