Vitamin D Deficiency
Conditions
Brief summary
Clinical Assessment of Adjunctive Omega-3 Versus Vitamin D daily Supplements on Active Periodontal Therapy with Stage II Grade B Periodontitis Patients: A Randomized controlled clinical trial.
Detailed description
This randomized clinical trial evaluates the effect of Omega- 3 versus Vitamin D regarding Clinical evaluation 1. Clinical attachment loss (CAL) 2. Plaque index (PI) 3. Gingival index (GI)
Interventions
PROCEDUREnon-surgical periodontal therapy (SRP)
* The CAL PPD and mSBI will be measured for each patient and will be recorded at baseline and 6 weeks * all patients will receive supragingival and sub-gingival plaque and calculus debridement (SRP) with an ultrasonic scaler (Various 350; NSK, Japan) and a manual universal curette (Gracey; Hu-Friday, Chicago, USA) where, conventional scaling and root planning (SRP) to the bottom of the pocket of 4 mm or more * Subgingival saline irrigation will be performed adjunctively to Sub-gingival curettage.
DIETARY_SUPPLEMENTnon-surgical periodontal therapy (SRP)+ Omega-3
* The CAL PPD and mSBI will be measured for each patient and will be recorded at baseline and 6 weeks * all patients will receive supragingival and sub-gingival plaque and calculus debridement (SRP) with an ultrasonic scaler (Various 350; NSK, Japan) and a manual universal curette (Gracey; Hu-Friday, Chicago, USA) * Subgingival saline irrigation will be performed adjunctively to Sub-gingival curettage. * Patients will start taking Omega-3 supplements on the day of SRP procedure.
DIETARY_SUPPLEMENTnon-surgical periodontal therapy (SRP)+ Vitamin D
* The CAL PPD and mSBI will be measured for each patient and will be recorded at baseline and 6 weeks * all patients will receive supragingival and sub-gingival plaque and calculus debridement (SRP) with an ultrasonic scaler (Various 350; NSK, Japan) and a manual universal curette (Gracey; Hu-Friday, Chicago, USA) where, conventional scaling and root planning (SRP) to the bottom of the pocket of 4 mm or more * Subgingival saline irrigation will be performed adjunctively to Sub-gingival curettage. * Serum vitamin D levels will be assessed at baseline and 6 weeks after intervention in all groups.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* • Systemic healthy patients * Patients aged \> 25 years * Patients suffering from stage II periodontitis with grade B were included in this study, according to 2017 world workshop classification of periodontal disease (Papapanou et al. 2017). * Patients with interdental clinical attachment loss (CAL) of 3-4 mm * No history of previous periodontal therapy. * No taken medications known to interfere healing or periodontal tissue health such as anticonvulsants, calcium channel blockers, or immunosuppressant drugs. * No previous periodontal surgery at involved sites. * Good oral hygiene and good compliance with the plaque control instructions following initial therapy. * Neither taken antibiotics within the last three months nor nonsteroidal anti-inflammatory drugs within the last three months * Absence of diseases or conditions that would interfere with wound healing such as diabetes mellitus or coagulation disorders * Absence of oral mucosal inflammatory conditions such as aphthous ulcers or lichen planus.
Exclusion criteria
* • Patients taking Omega- 3 or Vitamin D as a nutritional supplement were excluded from the study * Smoking habits * Pregnant and lactating mothers * Patients who have been received periodontal surgery in the study area during the last 6 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| clinical attachment loss (CAL) | Day 0 - month 3- month 6 | * All clinical outcomes will be measured baseline, 6 weeks after SRP alone and in conjunction with Omega- 3 and Vitamin D. * CAL will be measured form cemento- enamel junction (CEJ) to the depth of the pocket using UNC periodontal probe. * It will be recorded at 6 sites per tooth, the recorded readings will be used to generate mean values at each time point. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plaque index (PI) | Day 0 - month 3- month 6 | • through the Silness \& Loe plaque index score: score the thickness of plaque, sum the scores, and divide by the number of surfaces/teeth to get an average score. 0: no plaque - 1: thin film on gingival margin - 2: visible plaque in pocket and on gingival margin - 3: dense plaque in pocket and on gingival margin |
| Gingival index (GI) | Day 0- month 3- month 6 | through the modified Loe \& Silness score by assigning a score to each site based on these criteria as follows. 0: normal gingiva - 2: mild inflammation (slight color change, slight edema, no bleeding on probing) - 3: moderate inflammation (redness-edema-glazing-bleeding on probing) - 3: severe inflammation (marked redness, edema, spontaneous bleeding, or ulceration). |
Countries
Egypt
Outcome results
None listed