Curcumin Paste as an Adjunctive Therapy in Periodontitis

NCT04032132 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: FER16 20-M
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

The turmeric (Curcuma longa) plant, a herb belonging to the ginger family. The most active component of turmeric is curcumin, which makes up 2 to 5% of the spice. Curcumin showed has antibacterial effect against periodontal pathogen and positive result regarding conventional treatment of periodontal disease due to its anti-inflammatory, anti-oxidant and wound healing properties. This study will be carried out to examine the effect of curcumin when used in conjunction with open flap debridement treating deep periodontal pockets. (suggesting that it may have positive effect)

Conditions

Periodontitis

Keywords

curcumin; CBCT; HPLC; periodontitis

Outcome Measures

Primary Outcomes (1)

• clinical score

  Evaluate the influence of curcumin paste on the clinical outcomes of the surgical treatment.to see if curcumin has a positive effect in reduction oh deep periodontal pockets and leads to greater bone gain

  change from base line at 6 months

Study Arms (2)

curcumin paste in conjunction with open flap debridement surge

EXPERIMENTAL

curcumin paste (2% circumin) in conjunction with open flap debridement surgery

Drug: curcumin paste; Procedure: curettage

open flap debridement surgery only

PLACEBO COMPARATOR

surgical treatment for periodontal pocket

Procedure: curettage

Interventions

curcumin paste DRUG

curcumin is a herb used for medical purpose

curcumin paste in conjunction with open flap debridement surge

curettage PROCEDURE

open flab debridement surgery

curcumin paste in conjunction with open flap debridement surge; open flap debridement surgery only

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female with age range 25-45 years.
• At least a single posterior 2-3 wall periodontal defect of pocket depth ≥ 5mm; clinical attachment level ≥ 3 mm, Intrabony component ≥ 3 mm and with plaque index ≤1 (Löe 1967) and bleeding index ≤1 (Mühlemann \& Son 1971). All the previous criteria were determined 2 weeks after phase I conventional periodontal therapy.
• Systemically Healthy as evidenced by Burket's oral medicine health history questionnaire (Glick et al., 2008).

You may not qualify if:

• Smokers. 2- Pregnant. 3- Patient unwilling to comply to periodontaloral hygienic instructions. 4- Vulnerable groups. (e.g: Decisionally impaired individual)

Sponsors & Collaborators

• Ain Shams University: lead

MeSH Terms

Conditions

Periodontitis

Interventions

Curettage

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Ahmed Y Gamal, professor

  Faculty of dentistry -Ain Shams university

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Administrator of oral medicine and periodontology

Study Record Dates

• First Submitted: July 19, 2019
• First Posted: July 25, 2019
• Study Start: August 20, 2016
• Primary Completion: May 6, 2018
• Study Completion: November 5, 2018
• Last Updated: July 25, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share