Clinical trial NCT05435378: 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
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Periodontitis Stage I
Periodontal Diseases
Periodontal Inflammation
Periodontal Attachment Loss
Periodontitis
Periodontitis Stage II
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-06-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: change form the baseline in myeloperoxidase level in gingival crevicular fluid at 90 days
timeFrame: baseline and 90 days
measure: change form the baseline in clinical attachment level at 90 days
timeFrame: baseline and 90 days
Secondary outcomes:
measure: change form the baseline in periodontal pocket depth at 90 days
timeFrame: baseline and 90 days
measure: change form the baseline in bleeding on probing at 90 days
timeFrame: baseline and 90 days
measure: change form the baseline in plaque index at 90 days
timeFrame: parameter will be evaluated at baseline and at 90 days
measure: Patient satsification
timeFrame: Parameter will be evaluated at 90 days
Other outcomes:
Locations:
Study officials:
affiliation: main supervisor
name: Riham Omar, professor
role: STUDY_CHAIR
References: