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Assessment the Efficacy of Curcumin Local Delivery Gel in Treatment of Periodontitis in Smokers

Assessment the Efficacy of Curcumin Local Delivery Gel in Treatment of Periodontitis in Smokers. Randomized Controlled Clinical Trial

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06653231
Enrollment
30
Registered
2024-10-22
Start date
2024-11-01
Completion date
2025-03-01
Last updated
2025-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontitis

Keywords

curcumin, local delivery gel, smokers, periodontitis, RCT

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).

Interventions

DRUGlocal delivery of Curcumin gel

The test site will be completely undiluted curcumin gel through a 2 mL disposable syringe was placed in the test site

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Double blinded

Eligibility

Sex/Gender
ALL
Age
21 Years to 50 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
probing pocket depth45 daysThe depth of the pocket will be measured from the gingival margin to the base of the pocket.
clinical attachment level45 daysThe clinical attachment level will be measured from the CEJ to the base of pocket.

Secondary

MeasureTime frameDescription
gingival index45 daysScore 0 normal gingiva and no inflammation Score 1 mild inflammation with a slight change in colour, slight oedema, no bleeding on probing. Score 2 moderate inflammation with redness, oedema and glazing or bleeding on probing. Score 3 severe inflammation with marked redness and hypertrophy and a tendency toward spontaneous bleeding and ulceration.
Paque index45 daysScore 0 no plaque Score 1 A film of plaque adhering to the free gingival margin and adjacent area of the tooth, which cannot be seen with the naked eye but only by using disclosing solution or probe. Score 2 Moderate accumulation of soft deposits within the gingival pocket, on the gingival margin and/or adjacent tooth surface, which can be seen with the naked eye. Score 3 Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026