Periodontitis Clinical Trial
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
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.
Status | Not yet recruiting |
Enrollment | 30 |
Est. completion date | December 1, 2022 |
Est. primary completion date | October 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Cairo University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | 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 | baseline and 90 days | |
Secondary | 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. |
parameter will be evaluated at baseline and at 90 days | |
Secondary | 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 |
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