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

NCT ID: NCT05435378

Last Updated: 2022-06-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2022-12-01

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:

1. Non-surgical scaling and debridement with placebo

2. Non-surgical scaling and debridement with vitamin B-3

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

vitamin B3

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

Group Type: EXPERIMENTAL

Vitamin B3 100 MG Oral Tablet

Intervention Type: 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.

full mouth non surgical periodontal treatment

Intervention Type: 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.

Vitamin B-9

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

Group Type: EXPERIMENTAL

vitamin B9

Intervention Type: 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.

full mouth non surgical periodontal treatment

Intervention Type: 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

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

full mouth non surgical periodontal treatment

Intervention Type: 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.

Interventions

Vitamin B3 100 MG Oral Tablet

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

vitamin B9

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

Placebo

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: DRUG

full mouth non surgical periodontal treatment

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.

Intervention Type: PROCEDURE

Other Intervention Names

niacin; niacinamide; nicotinamide; Folic acid; Folate; folacin; inactive drug

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Elham Essam Hussien Elkholy

doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Riham Omar, professor

Role: STUDY_CHAIR

main supervisor

Central Contacts

Elham Elkholy

Role: CONTACT

elham.hussien@dentistry.cu.edu.eg

+201111342530

Other Identifiers

PER 3.3.2

Identifier Type: -

Identifier Source: org_study_id