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

NCT ID: NCT06653231

Last Updated: 2025-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2025-03-01

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).

Conditions

Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

SRP with local delivery of Curcumin gel

Scaling and root planing in combination with local delivery of Curcumin gel

Group Type: EXPERIMENTAL

local delivery of Curcumin gel

Intervention Type: DRUG

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

SRP alone

Scaling and root plaing alone

Group Type: ACTIVE_COMPARATOR

local delivery of Curcumin gel

Intervention Type: DRUG

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

Interventions

local 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

Intervention Type: DRUG

Other Intervention Names

turmeric plant Curcuma longa L

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Parryhan Mohamed Abdelsamie

Lecturer of periodontology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Parryhan M Abdelsamie

Role: PRINCIPAL_INVESTIGATOR

MTI University

Locations

MTI University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

102024

Identifier Type: -

Identifier Source: org_study_id