Diabete Mellitus, Periodontitis
Conditions
Brief summary
Background: Smoking reduces the effect of non-surgical periodontal therapy, a host modulation regimen consisting of omega-3 polyunsaturated fatty acids (ω-3 PUFA) supplementation with low-dose aspirin (ASA) with or without systemic doxycycline has been proposed to improve treatment response. The Aim of the study is to explore the clinical effects of orally administered omega-3 PUFA and ASA with or without systemic doxycycline with periodontal debridement in treatment of smoker individuals with stage III periodontitis.
Interventions
OTHEROmega-3 PUFA and Aspirin as adjunctive therapy to (SRP)
fifteen patients will receive ω-3 PUFA + ASA (1g of fish oil/day + 75mg ASA/day for 2 months) after periodontal debridement (TG1)
OTHEROmega-3 PUFA and Aspirin and doxycycline as adjunctive therapy to (SRP)
fifteen patients will receive ω-3 PUFA + ASA (1g of fish oil/day + 75mg ASA/day for 2 months) and oral dosage of doxycycline (100mg every 12 hours on day 1, then 100 mg once daily for 6 days) after periodontal debridement (TG2)
fifteen patients will receive periodontal debridement (CG)
Sponsors
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Smoker patients who smoke ≥ 10 cigarettes per day. * Stages III, Grades C periodontitis with at least one site with PD≥6 and CAL ≥5 mm.
Exclusion criteria
* Scaling and root planning in the previous 6 months(that may confound the effect of treatment) * Antimicrobial therapy in the previous 6 months(that may confound the effect of treatment) * Chronic systemic diseases that may have an impact on periodontitis progression (diabetes mellitus). * Systemic diseases that may contraindicate aspirin or doxycycline taking (kidney and liver diseases) * Allergy to doxycycline * Long-term usage of medications that may impair periodontal health * Allergy to fish/seafood
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in probing depth | baseline (t0) and at 3 (t1) and 6 months (t2) | the distance (in millimeters) from the gingival margin to the base of the gingival sulcus or periodontal pocket. |
| change in clinical attachment level | baseline (t0) and at 3 (t1) and 6 months (t2) | the distance (in millimeters) from the cemento-enamel junction (CEJ) to the base of the periodontal pocket. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in gingival index | baseline (t0) and at 3 (t1) and 6 months (t2) | score 0: Normal gingiva (pink, firm, no bleeding) score 1: Mild inflammation (Slight color change, Slight edema, No bleeding on probing) score 2:Moderate inflammation (Redness, edema, glazing, Bleeding on probing present) score 3: Severe inflammation (Marked redness and edema, Ulceration, Spontaneous bleeding) |
| change in bleeding on probing | baseline (t0) and at 3 (t1) and 6 months (t2) | presence of bleeding from the gingival sulcus or periodontal pocket within \~10 seconds after gentle probing. |
Countries
Egypt
Outcome results
None listed