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NCT Number: NCT06653231

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

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.

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Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

21 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

MTI University

Cairo, Egypt

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

local delivery of Curcumin gel

Drug

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

Other names: turmeric plant Curcuma longa L

Primary outcomes

  1. probing pocket depth

    Time frame: 45 days

    The depth of the pocket will be measured from the gingival margin to the base of the pocket.

  2. clinical attachment level

    Time frame: 45 days

    The clinical attachment level will be measured from the CEJ to the base of pocket.

Secondary outcomes

  1. gingival index

    Time frame: 45 days

    Score 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.

  2. Paque index

    Time frame: 45 days

    Score 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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 22, 2024
Registry last updated
Jul 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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