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

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.

Study Overview

• Status: Completed
• Conditions: Periodontitis
• Intervention / Treatment: Drug: local delivery of Curcumin gel

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).

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • MTI University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: SRP alone; Scaling and root plaing alone	Drug: 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; Other Names: turmeric plant Curcuma longa L
Experimental: SRP with local delivery of Curcumin gel; Scaling and root planing in combination with local delivery of Curcumin gel	Drug: 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; Other Names: turmeric plant Curcuma longa L

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
probing pocket depth	The depth of the pocket will be measured from the gingival margin to the base of the pocket.	45 days
clinical attachment level	The clinical attachment level will be measured from the CEJ to the base of pocket.	45 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
gingival index	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.	45 days
Paque index	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	45 days

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Parryhan M Abdelsamie, MTI University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Actual): February 1, 2025
• Study Completion (Actual): March 1, 2025

Study Registration Dates

• First Submitted: October 20, 2024
• First Submitted That Met QC Criteria: October 21, 2024
• First Posted (Actual): October 22, 2024

Study Record Updates

• Last Update Posted (Actual): July 18, 2025
• Last Update Submitted That Met QC Criteria: July 15, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: RCT; periodontitis; smokers; curcumin; local delivery gel
• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontitis; Antineoplastic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Antirheumatic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Anti-Inflammatory Agents, Non-Steroidal; Curcumin
• Other Study ID Numbers: 102024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No