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

NCT06653231 | Completed Early Phase 1

• 1 other identifier: 102024
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis

Keywords

curcumin; local delivery gel; smokers; periodontitis; RCT

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• gingival index

  45 days

• Paque index

  45 days

Study Arms (2)

SRP with local delivery of Curcumin gel

EXPERIMENTAL

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

Drug: local delivery of Curcumin gel

SRP alone

ACTIVE COMPARATOR

Scaling and root plaing alone

Drug: local delivery of Curcumin gel

Interventions

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

Also known as: turmeric plant Curcuma longa L

SRP alone; SRP with local delivery of Curcumin gel

Eligibility Criteria

• Age: 21 Years - 50 Years
• Gender Eligibility Details: age group between 21 and 50 years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

MTI University

Cairo, Egypt

Location

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Parryhan M Abdelsamie

  MTI University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of periodontology

Study Record Dates

• First Submitted: October 20, 2024
• First Posted: October 22, 2024
• Study Start: November 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: March 1, 2025
• Last Updated: July 18, 2025

Record last verified: 2025-07

Locations

EG (1)