Clinical trial NCT06653231: Assessment the Efficacy of Curcumin Local Delivery Gel in Treatment of Periodontitis in Smokers
Official title: Assessment the Efficacy of Curcumin Local Delivery Gel in Treatment of Periodontitis in Smokers. Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Periodontitis
Keywords: curcumin
local delivery gel
smokers
periodontitis
RCT
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-10-22
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Smokers usually respond less favourably to non-surgical periodontal treatment compared to non-smokers. Numerous studies reported that smoker patients exhibited less reduction in probing depth and less gains in clinical attachment level values following scaling and root planing (Kanmaz et al., 2021, Alwithanani, 2023)

Several studies have proposed the use of adjunctive treatment approaches such as local/systemic antimicrobials and anti-inflammatory agents to improve the effects of basic periodontal therapy in smokers. However, no studies have been published evaluated the conventional management of topically delivered curcumin gel in conjunction with scaling and root planing demonstrating its ability to improve periodontal outcomes in smokers.

Meanwhile, some clinical trials indicate that local and systemic administration of curcumin can enhance the results of SRP in periodontal treatment. Local delivery allows higher concentrations of the active compounds in the diseased site and avoids possible adverse effects of systemic administration.

Detailed description: Tobacco use increases the risk and progression of periodontitis by multiple factors including decreased gingival perfusion, which restricts nutrients and oxygen delivery as well as the removal of waste products. In addition, it affects the circulating levels of immune-inflammatory cells in gingival crevicular fluid, and affects the dysbiosis microbiota reducing the ability of the periodontium to repair.

Curcumin is an extract from the turmeric plant Curcuma longa L. It has been shown potent anti-microbial, anti-carcinogenic, antiviral, antioxidant, and anti-inflammatory properties.

In periodontitis, curcumin plays a pivotal role in anti-inflammatory properties, by inhibiting pro-inflammatory cytokines, reducing the prostaglandin biosynthesis, inhibiting the mRNA and protein expression of cyclo-oxygenase-2, through down-regulation of NF-kB activation.

Meanwhile, some clinical trials indicate that local and systemic administration of curcumin can enhance the results of SRP in periodontal treatment; local delivery allows higher concentrations of the active compounds in the diseased site and avoids possible adverse effects of systemic administration (Pérez-Pacheco et al., 2021, Borgohain et al., 2023, Chatzopoulos et al., 2023).

Eligibility criteria: Inclusion Criteria:

1. Patients diagnosed with generalized periodontitis with stage II
2. Nonsurgical or surgical periodontal therapy in the last 3 months were considered as eligible for the study.
3. Current smoker or smoker over the past 5 years.

Exclusion Criteria:

1. Presence of overhanging restorations,
2. antibiotics or any form of periodontal therapy in the previous 6 months.
3. History of systemic disease, cardiovascular diseases, diabetes mellitus, hypertension, bleeding disorders, hyperparathyroidism, and compromised medical conditions, pregnancy and lactation.
4. Teeth with both endo-perio lesions.
5. Patient on antibiotics within 3 months prior to the study.

Primary outcomes:
measure: probing pocket depth
timeFrame: 45 days
measure: clinical attachment level
timeFrame: 45 days
Secondary outcomes:
measure: gingival index
timeFrame: 45 days
measure: Paque index
timeFrame: 45 days
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: MTI University
Study officials:
affiliation: MTI University
name: Parryhan M Abdelsamie
role: PRINCIPAL_INVESTIGATOR
References: